Stage IV Non-Small Cell Lung Cancer Clinical Trial
Official title:
A Randomized Phase II/III Trial of Afatinib Plus Cetuximab Versus Afatinib Alone in Treatment-Naive Patients With Advanced, EGFR Mutation Positive Non-small Cell Lung Cancer (NSCLC)
Verified date | February 2024 |
Source | SWOG Cancer Research Network |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This randomized phase II/III trial studies how well afatinib dimaleate with cetuximab works and compares it with afatinib dimaleate alone in treating patients with newly diagnosed stage IV or recurrent (has come back), epidermal growth factor receptor (EGFR) mutation positive non-small cell lung cancer. Afatinib dimaleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab, may block tumor growth in different ways by targeting certain cells. It is not yet known whether afatinib dimaleate is more effective when given alone or with cetuximab in treating patients with non-small cell lung cancer.
Status | Active, not recruiting |
Enrollment | 174 |
Est. completion date | December 15, 2024 |
Est. primary completion date | September 25, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Patients must have histologically or cytologically confirmed stage IV (American Joint Committee on Cancer [AJCC] 7th Edition) or recurrent non-small cell lung cancer (NSCLC) - Patients must have documented presence of an EGFR exon 19 deltion or exon 21 (L858R) substitution mutation; T790M mutation or other molecular abnormality will be allowed as long as it accompanies one of the mutations listed above; EGFR testing must be performed using a Food and Drug Administration (FDA)-approved test or in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory. - Patients must have tissue available and must agree to submission of tissue and blood; one to two paraffin-embedded tissue blocks or 15-20 unstained slides are requested (a minimum of 12 slides is required); cytology (i.e. fine-needle aspirations, pleural effusion specimens) is acceptable if a cell block or sufficient unstained slides are available; tumor material must be reviewed by a local pathologist who must confirm that at least 100 viable tumor cells are present in the sample and sign the S1403 Pathology Review Form; patients must also be willing to submit blood samples for correlative research at baseline, during treatment and at progression - Patients enrolled at sites participating in the Repeat Biopsy Study must agree to submission of tissue obtained by a repeat biopsy performed at the time of disease progression - Patients must not have received any prior systemic anticancer therapy for advanced or metastatic disease including chemotherapy or EGFR tyrosine kinase inhibitor therapy (including gefitinib, erlotinib, afatinib, or any experimental EGFR tyrosine kinase inhibitors [TKI] agents); prior chemotherapy for non-metastatic disease (i.e. adjuvant therapy or concurrent chemo-radiotherapy) is allowed as long as > 12 months has passed since completion of therapy; adjuvant EGFR-directed therapy is not allowed; local therapy (i.e. palliative radiotherapy) is allowed as long as a period of 7 days has passed since the last dose was received and the patient has recovered from any associated toxicity at the time of registration - Patients may have measurable or non-measurable disease documented by computed tomography (CT) or magnetic resonance imaging (MRI) within 42 days prior to registration; the CT from a combined positron emission tomography (PET)/CT may be used only if it is of diagnostic quality; laboratory parameters are not acceptable as the only evidence of disease; in order to qualify as measurable, measurable disease must be outside previous radiation field; all disease must be assessed and documented on the Baseline Tumor Assessment Form (Response Evaluation Criteria in Solid Tumors [RECIST] 1.1) - Patients must have a CT or MRI scan of the brain to evaluate for central nervous system (CNS) disease within 42 days prior to registration; patient must not have symptomatic brain metastases or evidence of leptomeningeal carcinomatosis; patients with asymptomatic brain metastases are eligible if off of steroids for at least 7 days prior to registration without development of symptoms - Patients must not have any known clinically active interstitial lung disease - Absolute neutrophil count (ANC) >= 1,500/mcL - Platelets >= 75,000/mcL - Hemoglobin >= 9 g/dL - Total bilirubin =< 1.5 x institutional upper limit of normal (IULN) - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x IULN (or =< 5 x IULN for patients with known liver metastases) - Serum creatinine =< 1.5 x IULN OR measured or calculated creatinine clearance >= 60 mL/min - Patients must not have significant gastrointestinal disorders with diarrhea as a major symptom (e.g. Crohn's disease, malabsorption, etc) - Patients must be able to swallow medication by oral route - Patients must not have a history of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure New York Heart Association (NYHA) classification of 3, unstable angina or poorly controlled arrhythmia or myocardial infarction within 6 months prior to registration; if clinically indicated, echocardiogram or multigated acquisition (MUGA) must be performed and cardiac ejection fraction must be >= 50% - Patients must not have had major surgery within 28 days prior to registration or be scheduled for surgery during the projected course of protocol treatment; tumor biopsy is allowed - Patients must not have a known history of active hepatitis B infection (defined as presence of hepatitis B surface antigen [Hep B sAg] and/ or Hep B deoxyribonucleic acid [DNA]), active hepatitis C infection (defined as presence of hepatitis C [Hep C] ribonucleic acid [RNA]) and/or known human immunodeficiency virus (HIV) seropositive - Patients must not have any other concomitant serious illness or organ system dysfunction which in the opinion of the investigator would either compromise patient safety or interfere with the evaluation of the safety of the study drug - Patients must not be planning to receive any other investigational agents during the course of protocol treatment - Patients must not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to afatinib and/or cetuximab - Prestudy history and physical must be obtained with 28 days prior to registration - Patients must have Zubrod performance status of 0 - 2 - No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for three years - Patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method; a woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures - Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines - As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system |
Country | Name | City | State |
---|---|---|---|
United States | Hawaii Oncology Inc-Pali Momi | 'Aiea | Hawaii |
United States | Pali Momi Medical Center | 'Aiea | Hawaii |
United States | The Cancer Center of Hawaii-Pali Momi | 'Aiea | Hawaii |
United States | Akron General Medical Center | Akron | Ohio |
United States | Lovelace Medical Center-Saint Joseph Square | Albuquerque | New Mexico |
United States | New Mexico Oncology Hematology Consultants | Albuquerque | New Mexico |
United States | University of New Mexico Cancer Center | Albuquerque | New Mexico |
United States | Lehigh Valley Hospital-Cedar Crest | Allentown | Pennsylvania |
United States | Mary Greeley Medical Center | Ames | Iowa |
United States | McFarland Clinic PC-William R Bliss Cancer Center | Ames | Iowa |
United States | Kaiser Permanente-Anaheim | Anaheim | California |
United States | Saint Joseph Mercy Hospital | Ann Arbor | Michigan |
United States | University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan |
United States | Langlade Hospital and Cancer Center | Antigo | Wisconsin |
United States | PCR Oncology | Arroyo Grande | California |
United States | Asheville Hematology-Oncology Associates | Asheville | North Carolina |
United States | Cancer Care of Western North Carolina | Asheville | North Carolina |
United States | Mission Hospital-Memorial Campus | Asheville | North Carolina |
United States | Sutter Auburn Faith Hospital | Auburn | California |
United States | Sutter Cancer Centers Radiation Oncology Services-Auburn | Auburn | California |
United States | Harold Alfond Center for Cancer Care | Augusta | Maine |
United States | Rush - Copley Medical Center | Aurora | Illinois |
United States | Saint Alphonsus Medical Center-Baker City | Baker City | Oregon |
United States | AIS Cancer Center at San Joaquin Community Hospital | Bakersfield | California |
United States | Kaiser Permanente-Baldwin Park | Baldwin Park | California |
United States | Eastern Maine Medical Center | Bangor | Maine |
United States | Flaget Memorial Hospital | Bardstown | Kentucky |
United States | Boston Baskin Cancer Center-Bartlett | Bartlett | Tennessee |
United States | Bronson Battle Creek | Battle Creek | Michigan |
United States | UPMC-Heritage Valley Health System Beaver | Beaver | Pennsylvania |
United States | Indu and Raj Soin Medical Center | Beavercreek | Ohio |
United States | Kaiser Permanente-Bellflower | Bellflower | California |
United States | Strecker Cancer Center-Belpre | Belpre | Ohio |
United States | Sanford Clinic North-Bemidgi | Bemidji | Minnesota |
United States | Alta Bates Summit Medical Center-Herrick Campus | Berkeley | California |
United States | Lehigh Valley Hospital - Muhlenberg | Bethlehem | Pennsylvania |
United States | Constantinou, Costas L MD (UIA Investigator) | Bettendorf | Iowa |
United States | Beverly Hospital | Beverly | Massachusetts |
United States | Billings Clinic Cancer Center | Billings | Montana |
United States | Saint Vincent Healthcare | Billings | Montana |
United States | Sanford Bismarck Medical Center | Bismarck | North Dakota |
United States | Illinois CancerCare-Bloomington | Bloomington | Illinois |
United States | Saint Joseph Medical Center | Bloomington | Illinois |
United States | Saint Alphonsus Cancer Care Center-Boise | Boise | Idaho |
United States | Central Care Cancer Center - Bolivar | Bolivar | Missouri |
United States | Parkland Health Center-Bonne Terre | Bonne Terre | Missouri |
United States | McFarland Clinic PC-Boone | Boone | Iowa |
United States | Bozeman Deaconess Hospital | Bozeman | Montana |
United States | Cox Cancer Center Branson | Branson | Missouri |
United States | Harrison HealthPartners Hematology and Oncology-Bremerton | Bremerton | Washington |
United States | Harrison Medical Center | Bremerton | Washington |
United States | Lafayette Family Cancer Center-EMMC | Brewer | Maine |
United States | IHA Hematology Oncology Consultants-Brighton | Brighton | Michigan |
United States | Saint Joseph Mercy Brighton | Brighton | Michigan |
United States | Saint Joseph Regional Cancer Center | Bryan | Texas |
United States | Highline Medical Center-Main Campus | Burien | Washington |
United States | Mills-Peninsula Medical Center | Burlingame | California |
United States | Aurora Cancer Care-Southern Lakes VLCC | Burlington | Wisconsin |
United States | Lahey Hospital and Medical Center | Burlington | Massachusetts |
United States | Fairview Ridges Hospital | Burnsville | Minnesota |
United States | Saint James Community Hospital and Cancer Treatment Center | Butte | Montana |
United States | Saint Alphonsus Cancer Care Center-Caldwell | Caldwell | Idaho |
United States | Sutter Cancer Centers Radiation Oncology Services-Cameron Park | Cameron Park | California |
United States | IHA Hematology Oncology Consultants-Canton | Canton | Michigan |
United States | Illinois CancerCare-Canton | Canton | Illinois |
United States | Mercy Medical Center | Canton | Ohio |
United States | Saint Joseph Mercy Canton | Canton | Michigan |
United States | Saint Francis Medical Center | Cape Girardeau | Missouri |
United States | Southeast Cancer Center | Cape Girardeau | Missouri |
United States | Memorial Hospital of Carbondale | Carbondale | Illinois |
United States | Caro Cancer Center | Caro | Michigan |
United States | Carson Tahoe Regional Medical Center | Carson City | Nevada |
United States | SIH Cancer Institute | Carterville | Illinois |
United States | Illinois CancerCare-Carthage | Carthage | Illinois |
United States | Eden Hospital Medical Center | Castro Valley | California |
United States | Dayton Physicians LLC-Miami Valley South | Centerville | Ohio |
United States | Miami Valley Hospital South | Centerville | Ohio |
United States | Centralia Oncology Clinic | Centralia | Illinois |
United States | Christiana Care Health System-Concord Health Center | Chadds Ford | Pennsylvania |
United States | Cancer Center of Kansas - Chanute | Chanute | Kansas |
United States | Memorial Hospital | Chattanooga | Tennessee |
United States | IHA Hematology Oncology Consultants-Chelsea | Chelsea | Michigan |
United States | Saint Joseph Mercy Chelsea | Chelsea | Michigan |
United States | Adena Regional Medical Center | Chillicothe | Ohio |
United States | Marshfield Clinic-Chippewa Center | Chippewa Falls | Wisconsin |
United States | Bethesda North Hospital | Cincinnati | Ohio |
United States | Good Samaritan Hospital - Cincinnati | Cincinnati | Ohio |
United States | Oncology Hematology Care Inc - Anderson | Cincinnati | Ohio |
United States | Oncology Hematology Care Inc-Blue Ash | Cincinnati | Ohio |
United States | Oncology Hematology Care Inc-Eden Park | Cincinnati | Ohio |
United States | Oncology Hematology Care Inc-Kenwood | Cincinnati | Ohio |
United States | Oncology Hematology Care Inc-Mercy West | Cincinnati | Ohio |
United States | TriHealth Cancer Institute-Anderson | Cincinnati | Ohio |
United States | TriHealth Cancer Institute-Westside | Cincinnati | Ohio |
United States | Hematology Oncology Consultants-Clarkston | Clarkston | Michigan |
United States | Newland Medical Associates-Clarkston | Clarkston | Michigan |
United States | Sampson Radiation Oncology | Clinton | North Carolina |
United States | Southeastern Medical Oncology Center-Clinton | Clinton | North Carolina |
United States | Medical Oncology and Hematology Associates-West Des Moines | Clive | Iowa |
United States | Mercy Cancer Center-West Lakes | Clive | Iowa |
United States | Big Horn Basin Cancer Center | Cody | Wyoming |
United States | Billings Clinic-Cody | Cody | Wyoming |
United States | Kootenai Medical Center | Coeur d'Alene | Idaho |
United States | Coffeyville Regional Medical Center | Coffeyville | Kansas |
United States | Integrity Oncology PLLC-Collierville | Collierville | Tennessee |
United States | Penrose-Saint Francis Healthcare | Colorado Springs | Colorado |
United States | Rocky Mountain Cancer Centers-Penrose | Colorado Springs | Colorado |
United States | Columbus Oncology and Hematology Associates Inc | Columbus | Ohio |
United States | Doctors Hospital | Columbus | Ohio |
United States | Grant Medical Center | Columbus | Ohio |
United States | Mount Carmel Health Center West | Columbus | Ohio |
United States | Riverside Methodist Hospital | Columbus | Ohio |
United States | The Mark H Zangmeister Center | Columbus | Ohio |
United States | Mercy Hospital | Coon Rapids | Minnesota |
United States | Commonwealth Cancer Center-Corbin | Corbin | Kentucky |
United States | Alegent Health Mercy Hospital | Council Bluffs | Iowa |
United States | Greater Regional Medical Center | Creston | Iowa |
United States | Oncology Hematology Care Inc-Crestview | Crestview Hills | Kentucky |
United States | Carle on Vermilion | Danville | Illinois |
United States | Sutter Davis Hospital | Davis | California |
United States | Dayton Physicians LLC-Samaritan North | Dayton | Ohio |
United States | Good Samaritan Hospital - Dayton | Dayton | Ohio |
United States | Miami Valley Hospital | Dayton | Ohio |
United States | Samaritan North Health Center | Dayton | Ohio |
United States | Beaumont Hospital-Dearborn | Dearborn | Michigan |
United States | Cancer Care Specialists of Central Illinois | Decatur | Illinois |
United States | Decatur Memorial Hospital | Decatur | Illinois |
United States | Delaware Health Center-Grady Cancer Center | Delaware | Ohio |
United States | Delaware Radiation Oncology | Delaware | Ohio |
United States | Grady Memorial Hospital | Delaware | Ohio |
United States | Porter Adventist Hospital | Denver | Colorado |
United States | Smilow Cancer Hospital-Derby Care Center | Derby | Connecticut |
United States | Medical Oncology and Hematology Associates-Laurel | Des Moines | Iowa |
United States | Mercy Medical Center - Des Moines | Des Moines | Iowa |
United States | Saint John Hospital and Medical Center | Detroit | Michigan |
United States | Wayne State University/Karmanos Cancer Institute | Detroit | Michigan |
United States | Cancer Center of Kansas - Dodge City | Dodge City | Kansas |
United States | Mercy Medical Center | Durango | Colorado |
United States | Southwest Oncology PC | Durango | Colorado |
United States | Greenville Health System Cancer Institute-Easley | Easley | South Carolina |
United States | Great Lakes Cancer Management Specialists-Doctors Park | East China Township | Michigan |
United States | Marshfield Clinic Cancer Center - Eau Claire | Eau Claire | Wisconsin |
United States | Marshfield Clinic Cancer Center at Sacred Heart | Eau Claire | Wisconsin |
United States | Sacred Heart Hospital | Eau Claire | Wisconsin |
United States | Fairview-Southdale Hospital | Edina | Minnesota |
United States | Carle Physician Group-Effingham | Effingham | Illinois |
United States | Crossroads Cancer Center | Effingham | Illinois |
United States | Cancer Center of Kansas - El Dorado | El Dorado | Kansas |
United States | Elmhurst Memorial Hospital | Elmhurst | Illinois |
United States | Walter Knox Memorial Hospital | Emmett | Idaho |
United States | Englewood Hospital and Medical Center | Englewood | New Jersey |
United States | Saint Elizabeth Hospital | Enumclaw | Washington |
United States | Ephrata Cancer Center | Ephrata | Pennsylvania |
United States | Ephrata Community Hospital | Ephrata | Pennsylvania |
United States | Illinois CancerCare-Eureka | Eureka | Illinois |
United States | Deaconess Clinic Downtown | Evansville | Indiana |
United States | Oncology Hematology Care Inc-Healthplex | Fairfield | Ohio |
United States | Smilow Cancer Hospital Care Center-Fairfield | Fairfield | Connecticut |
United States | Roger Maris Cancer Center | Fargo | North Dakota |
United States | Sanford Broadway Medical Center | Fargo | North Dakota |
United States | Sanford Clinic North-Fargo | Fargo | North Dakota |
United States | Weisberg Cancer Treatment Center | Farmington Hills | Michigan |
United States | Saint Francis Hospital | Federal Way | Washington |
United States | Armes Family Cancer Center | Findlay | Ohio |
United States | Blanchard Valley Hospital | Findlay | Ohio |
United States | Orion Cancer Care | Findlay | Ohio |
United States | Genesee Cancer and Blood Disease Treatment Center | Flint | Michigan |
United States | Genesee Hematology Oncology PC | Flint | Michigan |
United States | Genesys Hurley Cancer Institute | Flint | Michigan |
United States | Hurley Medical Center | Flint | Michigan |
United States | McLeod Regional Medical Center | Florence | South Carolina |
United States | Aurora Health Center-Fond du Lac | Fond Du Lac | Wisconsin |
United States | Kaiser Permanente-Fontana | Fontana | California |
United States | McFarland Clinic PC-Trinity Cancer Center | Fort Dodge | Iowa |
United States | Cancer Center of Kansas - Fort Scott | Fort Scott | Kansas |
United States | Mercy Hospital Fort Smith | Fort Smith | Arkansas |
United States | Parkview Hospital Randallia | Fort Wayne | Indiana |
United States | Atrium Medical Center-Middletown Regional Hospital | Franklin | Ohio |
United States | Dayton Physicians LLC-Atrium | Franklin | Ohio |
United States | Vanderbilt-Ingram Cancer Center Cool Springs | Franklin | Tennessee |
United States | Palo Alto Medical Foundation-Fremont | Fremont | California |
United States | Unity Hospital | Fridley | Minnesota |
United States | Illinois CancerCare-Galesburg | Galesburg | Illinois |
United States | Western Illinois Cancer Treatment Center | Galesburg | Illinois |
United States | Saint Catherine Hospital | Garden City | Kansas |
United States | Aurora Health Care Germantown Health Center | Germantown | Wisconsin |
United States | Adams Cancer Center | Gettysburg | Pennsylvania |
United States | Addison Gilbert Hospital | Gloucester | Massachusetts |
United States | Mountain Blue Cancer Care Center | Golden | Colorado |
United States | Southeastern Medical Oncology Center-Goldsboro | Goldsboro | North Carolina |
United States | Wayne Memorial Hospital | Goldsboro | North Carolina |
United States | Wayne Radiation Oncology | Goldsboro | North Carolina |
United States | Aurora Cancer Care-Grafton | Grafton | Wisconsin |
United States | Altru Cancer Center | Grand Forks | North Dakota |
United States | CHI Health Saint Francis | Grand Island | Nebraska |
United States | Mercy Health Saint Mary's | Grand Rapids | Michigan |
United States | Spectrum Health at Butterworth Campus | Grand Rapids | Michigan |
United States | Three Rivers Community Hospital | Grants Pass | Oregon |
United States | Central Care Cancer Center - Great Bend | Great Bend | Kansas |
United States | Saint Rose Ambulatory and Surgery Center | Great Bend | Kansas |
United States | Benefis Healthcare- Sletten Cancer Institute | Great Falls | Montana |
United States | Aurora BayCare Medical Center | Green Bay | Wisconsin |
United States | UPMC Cancer Centers - Arnold Palmer Pavilion | Greensburg | Pennsylvania |
United States | Dayton Physicians LLC-Wayne | Greenville | Ohio |
United States | Greenville Health System Cancer Institute-Butternut | Greenville | South Carolina |
United States | Greenville Health System Cancer Institute-Eastside | Greenville | South Carolina |
United States | Greenville Health System Cancer Institute-Faris | Greenville | South Carolina |
United States | Greenville Memorial Hospital | Greenville | South Carolina |
United States | Saint Francis Cancer Center | Greenville | South Carolina |
United States | Saint Francis Hospital | Greenville | South Carolina |
United States | Wayne Hospital | Greenville | Ohio |
United States | Greenville Health System Cancer Institute-Greer | Greer | South Carolina |
United States | Great Lakes Cancer Management Specialists-Van Elslander Cancer Center | Grosse Pointe Woods | Michigan |
United States | Lymphoma Clinic of Michigan | Grosse Pointe Woods | Michigan |
United States | Michigan Breast Specialists-Grosse Pointe Woods | Grosse Pointe Woods | Michigan |
United States | Yale-New Haven Shoreline Medical Center | Guilford | Connecticut |
United States | Cherry Tree Cancer Center | Hanover | Pennsylvania |
United States | Kaiser Permanente - Harbor City | Harbor City | California |
United States | Smilow Cancer Hospital Care Center at Saint Francis | Hartford | Connecticut |
United States | Hays Medical Center | Hays | Kansas |
United States | Saint Peter's Community Hospital | Helena | Montana |
United States | 21st Century Oncology-Henderson | Henderson | Nevada |
United States | Cancer and Blood Specialists-Henderson | Henderson | Nevada |
United States | Comprehensive Cancer Centers of Nevada - Henderson | Henderson | Nevada |
United States | Comprehensive Cancer Centers of Nevada-Horizon Ridge | Henderson | Nevada |
United States | Comprehensive Cancer Centers of Nevada-Southeast Henderson | Henderson | Nevada |
United States | Las Vegas Cancer Center-Henderson | Henderson | Nevada |
United States | Hendersonville Hematology and Oncology at Pardee | Hendersonville | North Carolina |
United States | Margaret R Pardee Memorial Hospital | Hendersonville | North Carolina |
United States | Park Ridge Hospital Breast Health Center | Hendersonville | North Carolina |
United States | Pulmonary Medicine Center of Chattanooga-Hixson | Hixson | Tennessee |
United States | Hawaii Cancer Care Inc-Liliha | Honolulu | Hawaii |
United States | Hawaii Cancer Care Inc-POB II | Honolulu | Hawaii |
United States | Hawaii Oncology Inc-Kuakini | Honolulu | Hawaii |
United States | Hawaii Oncology Inc-POB I | Honolulu | Hawaii |
United States | Island Urology | Honolulu | Hawaii |
United States | Kapiolani Medical Center for Women and Children | Honolulu | Hawaii |
United States | Kuakini Medical Center | Honolulu | Hawaii |
United States | Queen's Medical Center | Honolulu | Hawaii |
United States | Straub Clinic and Hospital | Honolulu | Hawaii |
United States | The Cancer Center of Hawaii-Liliha | Honolulu | Hawaii |
United States | University of Hawaii Cancer Center | Honolulu | Hawaii |
United States | CHI Saint Vincent Cancer Center Hot Springs | Hot Springs | Arkansas |
United States | Saint Mary's Medical Center | Huntington | West Virginia |
United States | Cancer Center of Kansas-Independence | Independence | Kansas |
United States | Centerpoint Medical Center LLC | Independence | Missouri |
United States | Kaiser Permanente-Irvine | Irvine | California |
United States | Allegiance Health | Jackson | Michigan |
United States | Baptist MD Anderson Cancer Center | Jacksonville | Florida |
United States | Onslow Memorial Hospital | Jacksonville | North Carolina |
United States | Southeastern Medical Oncology Center-Jacksonville | Jacksonville | North Carolina |
United States | McFarland Clinic PC-Jefferson | Jefferson | Iowa |
United States | Capital Region Medical Center-Goldschmidt Cancer Center | Jefferson City | Missouri |
United States | UPMC-Johnstown/John P. Murtha Regional Cancer Center | Johnstown | Pennsylvania |
United States | Fowler Family Center for Cancer Care | Jonesboro | Arkansas |
United States | Freeman Health System | Joplin | Missouri |
United States | Mercy Hospital Joplin | Joplin | Missouri |
United States | Borgess Medical Center | Kalamazoo | Michigan |
United States | Bronson Methodist Hospital | Kalamazoo | Michigan |
United States | West Michigan Cancer Center | Kalamazoo | Michigan |
United States | Kalispell Regional Medical Center | Kalispell | Montana |
United States | Heartland Hematology and Oncology Associates Incorporated | Kansas City | Missouri |
United States | Kansas City Veterans Affairs Medical Center | Kansas City | Missouri |
United States | Research Medical Center | Kansas City | Missouri |
United States | Saint Luke's Hospital of Kansas City | Kansas City | Missouri |
United States | The University of Kansas Cancer Center-North | Kansas City | Missouri |
United States | The University of Kansas Cancer Center-South | Kansas City | Missouri |
United States | Truman Medical Center | Kansas City | Missouri |
United States | University of Kansas Cancer Center | Kansas City | Kansas |
United States | University of Kansas Cancer Center-West | Kansas City | Kansas |
United States | CHI Health Good Samaritan | Kearney | Nebraska |
United States | Heartland Hematology and Oncology | Kearney | Nebraska |
United States | Aurora Cancer Care-Kenosha South | Kenosha | Wisconsin |
United States | First Dayton Cancer Care | Kettering | Ohio |
United States | Greater Dayton Cancer Center | Kettering | Ohio |
United States | Kettering Medical Center | Kettering | Ohio |
United States | Illinois CancerCare-Kewanee Clinic | Kewanee | Illinois |
United States | Cancer Center of Kansas-Kingman | Kingman | Kansas |
United States | Kinston Medical Specialists PA | Kinston | North Carolina |
United States | Gundersen Lutheran Medical Center | La Crosse | Wisconsin |
United States | UC San Diego Moores Cancer Center | La Jolla | California |
United States | Marshfield Clinic - Ladysmith Center | Ladysmith | Wisconsin |
United States | Rocky Mountain Cancer Centers-Lakewood | Lakewood | Colorado |
United States | Saint Anthony Hospital | Lakewood | Colorado |
United States | Saint Clare Hospital | Lakewood | Washington |
United States | Fairfield Medical Center | Lancaster | Ohio |
United States | Sparrow Hospital | Lansing | Michigan |
United States | Memorial Medical Center - Las Cruces | Las Cruces | New Mexico |
United States | 21st Century Oncology | Las Vegas | Nevada |
United States | 21st Century Oncology-Fort Apache | Las Vegas | Nevada |
United States | 21st Century Oncology-Vegas Tenaya | Las Vegas | Nevada |
United States | Ann M Wierman MD LTD | Las Vegas | Nevada |
United States | Cancer and Blood Specialists-Shadow | Las Vegas | Nevada |
United States | Cancer and Blood Specialists-Tenaya | Las Vegas | Nevada |
United States | Cancer Therapy and Integrative Medicine | Las Vegas | Nevada |
United States | Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada |
United States | Comprehensive Cancer Centers of Nevada - Central Valley | Las Vegas | Nevada |
United States | Comprehensive Cancer Centers of Nevada - Northwest | Las Vegas | Nevada |
United States | Comprehensive Cancer Centers of Nevada-Summerlin | Las Vegas | Nevada |
United States | HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills | Las Vegas | Nevada |
United States | HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway | Las Vegas | Nevada |
United States | HealthCare Partners Medical Group Oncology/Hematology-San Martin | Las Vegas | Nevada |
United States | HealthCare Partners Medical Group Oncology/Hematology-Tenaya | Las Vegas | Nevada |
United States | Las Vegas Cancer Center-Medical Center | Las Vegas | Nevada |
United States | Nevada Cancer Specialists-Fort Apache | Las Vegas | Nevada |
United States | Radiation Oncology Centers of Nevada Central | Las Vegas | Nevada |
United States | Radiation Oncology Centers of Nevada Southeast | Las Vegas | Nevada |
United States | Summerlin Hospital Medical Center | Las Vegas | Nevada |
United States | University Cancer Center | Las Vegas | Nevada |
United States | University Medical Center of Southern Nevada | Las Vegas | Nevada |
United States | Lawrence Memorial Hospital | Lawrence | Kansas |
United States | Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire |
United States | Sechler Family Cancer Center | Lebanon | Pennsylvania |
United States | Saint Luke's East - Lee's Summit | Lee's Summit | Missouri |
United States | The University of Kansas Cancer Center-Lee's Summit | Lee's Summit | Missouri |
United States | Kansas Institute of Medicine Cancer and Blood Center | Lenexa | Kansas |
United States | Minimally Invasive Surgery Hospital | Lenexa | Kansas |
United States | Beebe Medical Center | Lewes | Delaware |
United States | Saint Joseph Hospital East | Lexington | Kentucky |
United States | Saint Joseph Radiation Oncology Resource Center | Lexington | Kentucky |
United States | Cancer Center of Kansas-Liberal | Liberal | Kansas |
United States | Liberty Radiation Oncology Center | Liberty | Missouri |
United States | Wilcox Memorial Hospital and Kauai Medical Clinic | Lihue | Hawaii |
United States | Nebraska Cancer Research Center | Lincoln | Nebraska |
United States | Nebraska Hematology and Oncology | Lincoln | Nebraska |
United States | Saint Elizabeth Regional Medical Center | Lincoln | Nebraska |
United States | Southeast Nebraska Cancer Center | Lincoln | Nebraska |
United States | Littleton Adventist Hospital | Littleton | Colorado |
United States | Hope Cancer Clinic | Livonia | Michigan |
United States | Saint Mary Mercy Hospital | Livonia | Michigan |
United States | Longmont United Hospital | Longmont | Colorado |
United States | Rocky Mountain Cancer Centers-Longmont | Longmont | Colorado |
United States | Kaiser Permanente Los Angeles Medical Center | Los Angeles | California |
United States | Kaiser Permanente-Cadillac | Los Angeles | California |
United States | Jewish Hospital | Louisville | Kentucky |
United States | Jewish Hospital Medical Center Northeast | Louisville | Kentucky |
United States | Saints Mary and Elizabeth Hospital | Louisville | Kentucky |
United States | Great Lakes Cancer Management Specialists-Macomb Medical Campus | Macomb | Michigan |
United States | Illinois CancerCare-Macomb | Macomb | Illinois |
United States | Michigan Breast Specialists-Macomb Township | Macomb | Michigan |
United States | Central Georgia Gynecologic Oncology | Macon | Georgia |
United States | Medical Center of Central Georgia | Macon | Georgia |
United States | Norris Cotton Cancer Center-Manchester | Manchester | New Hampshire |
United States | Cancer Center of Kansas-Manhattan | Manhattan | Kansas |
United States | Fairview Maple Grove Medical Center | Maple Grove | Minnesota |
United States | Minnesota Oncology Hematology PA-Maplewood | Maplewood | Minnesota |
United States | Saint John's Hospital - Healtheast | Maplewood | Minnesota |
United States | Marietta Memorial Hospital | Marietta | Ohio |
United States | Aurora Bay Area Medical Group-Marinette | Marinette | Wisconsin |
United States | Bay Area Medical Center | Marinette | Wisconsin |
United States | Vince Lombardi Cancer Clinic-Marinette | Marinette | Wisconsin |
United States | Saint Mary's Oncology/Hematology Associates of Marlette | Marlette | Michigan |
United States | UP Health System Hematology Oncology Marquette | Marquette | Michigan |
United States | UP Health System Marquette | Marquette | Michigan |
United States | McFarland Clinic PC-Marshalltown | Marshalltown | Iowa |
United States | Marshfield Clinic | Marshfield | Wisconsin |
United States | Marshfield Medical Center | Marshfield | Wisconsin |
United States | Fremont - Rideout Cancer Center | Marysville | California |
United States | Carle Physician Group-Mattoon/Charleston | Mattoon | Illinois |
United States | Loyola University Medical Center | Maywood | Illinois |
United States | UPMC Cancer Center at UPMC McKeesport | McKeesport | Pennsylvania |
United States | Cancer Center of Kansas - McPherson | McPherson | Kansas |
United States | Providence Medford Medical Center | Medford | Oregon |
United States | Rogue Valley Medical Center | Medford | Oregon |
United States | Baptist Memorial Hospital and Cancer Center-Memphis | Memphis | Tennessee |
United States | Baptist Memorial Hospital for Women | Memphis | Tennessee |
United States | Family Cancer Center-Memphis | Memphis | Tennessee |
United States | Columbia Saint Mary's Hospital - Ozaukee | Mequon | Wisconsin |
United States | Mercy UC Davis Cancer Center | Merced | California |
United States | Idaho Urologic Institute-Meridian | Meridian | Idaho |
United States | Franciscan Saint Anthony Health-Michigan City | Michigan City | Indiana |
United States | Woodland Cancer Care Center | Michigan City | Indiana |
United States | Dayton Physicians LLC-Signal Point | Middletown | Ohio |
United States | Middlesex Hospital | Middletown | Connecticut |
United States | Orange Regional Medical Center | Middletown | New York |
United States | Aurora Cancer Care-Milwaukee | Milwaukee | Wisconsin |
United States | Aurora Saint Luke's Medical Center | Milwaukee | Wisconsin |
United States | Aurora Sinai Medical Center | Milwaukee | Wisconsin |
United States | Columbia Saint Mary's Water Tower Medical Commons | Milwaukee | Wisconsin |
United States | Abbott-Northwestern Hospital | Minneapolis | Minnesota |
United States | Health Partners Inc | Minneapolis | Minnesota |
United States | Hennepin County Medical Center | Minneapolis | Minnesota |
United States | Marshfield Clinic-Minocqua Center | Minocqua | Wisconsin |
United States | Trinity Cancer Care Center | Minot | North Dakota |
United States | Community Medical Hospital | Missoula | Montana |
United States | Saint Patrick Hospital - Community Hospital | Missoula | Montana |
United States | Memorial Medical Center | Modesto | California |
United States | Garneau, Stewart C MD (UIA Investigator) | Moline | Illinois |
United States | Spector, David MD (UIA Investigator) | Moline | Illinois |
United States | Trinity Medical Center | Moline | Illinois |
United States | Monroe Cancer Center | Monroe | Michigan |
United States | UPMC-Coraopolis/Heritage Valley Radiation Oncology | Moon | Pennsylvania |
United States | Good Samaritan Regional Health Center | Mount Vernon | Illinois |
United States | Knox Community Hospital | Mount Vernon | Ohio |
United States | Palo Alto Medical Foundation-Camino Division | Mountain View | California |
United States | Palo Alto Medical Foundation-Gynecologic Oncology | Mountain View | California |
United States | Mercy Health Mercy Campus | Muskegon | Michigan |
United States | Saint Alphonsus Medical Center-Nampa | Nampa | Idaho |
United States | Edward Hospital/Cancer Center | Naperville | Illinois |
United States | Norris Cotton Cancer Center-Nashua | Nashua | New Hampshire |
United States | Vanderbilt Breast Center at One Hundred Oaks | Nashville | Tennessee |
United States | Vanderbilt University/Ingram Cancer Center | Nashville | Tennessee |
United States | Baptist Memorial Hospital and Cancer Center-Union County | New Albany | Mississippi |
United States | Yale University | New Haven | Connecticut |
United States | Cancer Center of Western Wisconsin | New Richmond | Wisconsin |
United States | New Ulm Medical Center | New Ulm | Minnesota |
United States | Christiana Care Health System-Christiana Hospital | Newark | Delaware |
United States | Delaware Clinical and Laboratory Physicians PA | Newark | Delaware |
United States | Helen F Graham Cancer Center | Newark | Delaware |
United States | Licking Memorial Hospital | Newark | Ohio |
United States | Medical Oncology Hematology Consultants PA | Newark | Delaware |
United States | Newark Beth Israel Medical Center | Newark | New Jersey |
United States | Newark Radiation Oncology | Newark | Ohio |
United States | Regional Hematology and Oncology PA | Newark | Delaware |
United States | Chancellor Center for Oncology | Newburgh | Indiana |
United States | Cancer Center of Kansas - Newton | Newton | Kansas |
United States | Lakeland Community Hospital | Niles | Michigan |
United States | Faith Regional Health Services Carson Cancer Center | Norfolk | Nebraska |
United States | Yale-New Haven Hospital North Haven Medical Center | North Haven | Connecticut |
United States | Great Plains Health Callahan Cancer Center | North Platte | Nebraska |
United States | Sutter Cancer Research Consortium | Novato | California |
United States | Mercy Hospital Oklahoma City | Oklahoma City | Oklahoma |
United States | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma |
United States | Olathe Medical Center | Olathe | Kansas |
United States | Alegent Health Bergan Mercy Medical Center | Omaha | Nebraska |
United States | Alegent Health Immanuel Medical Center | Omaha | Nebraska |
United States | Alegent Health Lakeside Hospital | Omaha | Nebraska |
United States | Creighton University Medical Center | Omaha | Nebraska |
United States | Hematology and Oncology Consultants PC | Omaha | Nebraska |
United States | Nebraska Cancer Specialists - Omaha | Omaha | Nebraska |
United States | Nebraska Methodist Hospital | Omaha | Nebraska |
United States | Oncology Hematology West PC | Omaha | Nebraska |
United States | Saint Alphonsus Medical Center-Ontario | Ontario | Oregon |
United States | Memorial GYN Plus | Ooltewah | Tennessee |
United States | Smilow Cancer Hospital-Orange Care Center | Orange | Connecticut |
United States | Vince Lombardi Cancer Clinic - Oshkosh | Oshkosh | Wisconsin |
United States | Illinois CancerCare-Ottawa Clinic | Ottawa | Illinois |
United States | Radiation Oncology of Northern Illinois | Ottawa | Illinois |
United States | Menorah Medical Center | Overland Park | Kansas |
United States | Saint Luke's South Hospital | Overland Park | Kansas |
United States | University of Kansas Cancer Center-Overland Park | Overland Park | Kansas |
United States | Baptist Memorial Hospital and Cancer Center-Oxford | Oxford | Mississippi |
United States | Hope Cancer Care of Nevada-Pahrump | Pahrump | Nevada |
United States | Palo Alto Medical Foundation Health Care | Palo Alto | California |
United States | Kaiser Permanente - Panorama City | Panorama City | California |
United States | Midlands Community Hospital | Papillion | Nebraska |
United States | Parker Adventist Hospital | Parker | Colorado |
United States | Rocky Mountain Cancer Centers-Parker | Parker | Colorado |
United States | Cancer Center of Kansas - Parsons | Parsons | Kansas |
United States | Singing River Hospital | Pascagoula | Mississippi |
United States | Illinois CancerCare-Pekin | Pekin | Illinois |
United States | OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center | Pekin | Illinois |
United States | Sacred Heart Hospital | Pensacola | Florida |
United States | Illinois CancerCare-Peoria | Peoria | Illinois |
United States | Methodist Medical Center of Illinois | Peoria | Illinois |
United States | OSF Saint Francis Medical Center | Peoria | Illinois |
United States | OSF Saint Francis Radiation Oncology at Peoria Cancer Center | Peoria | Illinois |
United States | Illinois CancerCare-Peru | Peru | Illinois |
United States | Valley Radiation Oncology | Peru | Illinois |
United States | Temple University Hospital | Philadelphia | Pennsylvania |
United States | Via Christi Hospital-Pittsburg | Pittsburg | Kansas |
United States | University of Pittsburgh Cancer Institute (UPCI) | Pittsburgh | Pennsylvania |
United States | UPMC-Magee Womens Hospital | Pittsburgh | Pennsylvania |
United States | UPMC-Passavant Hospital | Pittsburgh | Pennsylvania |
United States | UPMC-Presbyterian Hospital | Pittsburgh | Pennsylvania |
United States | UPMC-Saint Clair Hospital Cancer Center | Pittsburgh | Pennsylvania |
United States | UPMC-Saint Margaret | Pittsburgh | Pennsylvania |
United States | UPMC-Shadyside Hospital | Pittsburgh | Pennsylvania |
United States | Edward Hospital/Cancer Center?Plainfield | Plainfield | Illinois |
United States | 21st Century Oncology-Pontiac | Pontiac | Michigan |
United States | Hope Cancer Center | Pontiac | Michigan |
United States | Newland Medical Associates-Pontiac | Pontiac | Michigan |
United States | Saint Joseph Mercy Oakland | Pontiac | Michigan |
United States | Huron Medical Center PC | Port Huron | Michigan |
United States | Lake Huron Medical Center | Port Huron | Michigan |
United States | Kaiser Permanente Northwest | Portland | Oregon |
United States | Southern Ohio Medical Center | Portsmouth | Ohio |
United States | Kootenai Cancer Center | Post Falls | Idaho |
United States | Harrison HealthPartners Hematology and Oncology-Poulsbo | Poulsbo | Washington |
United States | Kansas City NCI Community Oncology Research Program | Prairie Village | Kansas |
United States | Cancer Center of Kansas - Pratt | Pratt | Kansas |
United States | Illinois CancerCare-Princeton | Princeton | Illinois |
United States | Rocky Mountain Cancer Centers - Pueblo | Pueblo | Colorado |
United States | Saint Mary Corwin Medical Center | Pueblo | Colorado |
United States | Aurora Cancer Care-Racine | Racine | Wisconsin |
United States | Eisenhower Medical Center | Rancho Mirage | California |
United States | Penn State Health Saint Joseph Medical Center | Reading | Pennsylvania |
United States | Spectrum Health Reed City Hospital | Reed City | Michigan |
United States | Beebe Health Campus | Rehoboth Beach | Delaware |
United States | Radiation Oncology Associates | Reno | Nevada |
United States | Renown Regional Medical Center | Reno | Nevada |
United States | Saint Mary's Regional Medical Center | Reno | Nevada |
United States | Lakeview Medical Center-Marshfield Clinic | Rice Lake | Wisconsin |
United States | Marshfield Clinic-Rice Lake Center | Rice Lake | Wisconsin |
United States | Reid Health | Richmond | Indiana |
United States | Kaiser Permanente-Riverside | Riverside | California |
United States | North Memorial Medical Health Center | Robbinsdale | Minnesota |
United States | University of Rochester | Rochester | New York |
United States | Great Lakes Cancer Management Specialists-Rochester Hills | Rochester Hills | Michigan |
United States | SwedishAmerican Regional Cancer Center/ACT | Rockford | Illinois |
United States | Penobscot Bay Medical Center | Rockport | Maine |
United States | Delbert Day Cancer Institute at PCRMC | Rolla | Missouri |
United States | Mercy Clinic-Rolla-Cancer and Hematology | Rolla | Missouri |
United States | Sutter Cancer Centers Radiation Oncology Services-Roseville | Roseville | California |
United States | Sutter Roseville Medical Center | Roseville | California |
United States | Sutter Medical Center Sacramento | Sacramento | California |
United States | University of California Davis Comprehensive Cancer Center | Sacramento | California |
United States | Oncology Hematology Associates of Saginaw Valley PC | Saginaw | Michigan |
United States | Saint Mary's of Michigan | Saginaw | Michigan |
United States | Norris Cotton Cancer Center-North | Saint Johnsbury | Vermont |
United States | Heartland Regional Medical Center | Saint Joseph | Missouri |
United States | Lakeland Hospital | Saint Joseph | Michigan |
United States | Marie Yeager Cancer Center | Saint Joseph | Michigan |
United States | Mercy Hospital Saint Louis | Saint Louis | Missouri |
United States | Missouri Baptist Medical Center | Saint Louis | Missouri |
United States | Saint Louis Cancer and Breast Institute-South City | Saint Louis | Missouri |
United States | Park Nicollet Clinic - Saint Louis Park | Saint Louis Park | Minnesota |
United States | Regions Hospital | Saint Paul | Minnesota |
United States | United Hospital | Saint Paul | Minnesota |
United States | Sainte Genevieve County Memorial Hospital | Sainte Genevieve | Missouri |
United States | Cancer Center of Kansas - Salina | Salina | Kansas |
United States | Salina Regional Health Center | Salina | Kansas |
United States | University of Texas Health Science Center at San Antonio | San Antonio | Texas |
United States | Kaiser Permanente-San Diego Mission | San Diego | California |
United States | Kaiser Permanente-San Diego Zion | San Diego | California |
United States | California Pacific Medical Center-Pacific Campus | San Francisco | California |
United States | Kaiser Permanente-San Marcos | San Marcos | California |
United States | Kootenai Cancer Clinic | Sandpoint | Idaho |
United States | Palo Alto Medical Foundation-Santa Cruz | Santa Cruz | California |
United States | Christus Saint Vincent Regional Cancer Center | Santa Fe | New Mexico |
United States | Sutter Pacific Medical Foundation | Santa Rosa | California |
United States | Lewis Cancer and Research Pavilion at Saint Joseph's/Candler | Savannah | Georgia |
United States | Low Country Cancer Care Associates PC | Savannah | Georgia |
United States | Memorial University Medical Center | Savannah | Georgia |
United States | Summit Cancer Care-Candler | Savannah | Georgia |
United States | Summit Cancer Care-Memorial | Savannah | Georgia |
United States | Guthrie Medical Group PC-Robert Packer Hospital | Sayre | Pennsylvania |
United States | Regional West Medical Center Cancer Center | Scottsbluff | Nebraska |
United States | Nanticoke Memorial Hospital | Seaford | Delaware |
United States | Greenville Health System Cancer Institute-Seneca | Seneca | South Carolina |
United States | UPMC Cancer Center at UPMC Northwest | Seneca | Pennsylvania |
United States | Saint Francis Regional Medical Center | Shakopee | Minnesota |
United States | Vince Lombardi Cancer Clinic-Sheboygan | Sheboygan | Wisconsin |
United States | Jewish Hospital Medical Center South | Shepherdsville | Kentucky |
United States | Welch Cancer Center | Sheridan | Wyoming |
United States | Dayton Physicians LLC-Wilson | Sidney | Ohio |
United States | Siouxland Regional Cancer Center | Sioux City | Iowa |
United States | Sanford Cancer Center Oncology Clinic | Sioux Falls | South Dakota |
United States | Sanford USD Medical Center - Sioux Falls | Sioux Falls | South Dakota |
United States | Baptist Memorial Hospital and Cancer Center-Desoto | Southhaven | Mississippi |
United States | Greenville Health System Cancer Institute-Spartanburg | Spartanburg | South Carolina |
United States | Central Illinois Hematology Oncology Center | Springfield | Illinois |
United States | CoxHealth South Hospital | Springfield | Missouri |
United States | Memorial Medical Center | Springfield | Illinois |
United States | Mercy Hospital Springfield | Springfield | Missouri |
United States | Southern Illinois University School of Medicine | Springfield | Illinois |
United States | Springfield Clinic | Springfield | Illinois |
United States | Springfield Regional Cancer Center | Springfield | Ohio |
United States | Springfield Regional Medical Center | Springfield | Ohio |
United States | Bhadresh Nayak MD PC-Sterling Heights | Sterling Heights | Michigan |
United States | Ascension Saint Michael's Hospital | Stevens Point | Wisconsin |
United States | Marshfield Clinic Stevens Point Center | Stevens Point | Wisconsin |
United States | Saint Michael's Hospital | Stevens Point | Wisconsin |
United States | Lakeview Hospital | Stillwater | Minnesota |
United States | Missouri Baptist Sullivan Hospital | Sullivan | Missouri |
United States | Aurora Medical Center in Summit | Summit | Wisconsin |
United States | Palo Alto Medical Foundation-Sunnyvale | Sunnyvale | California |
United States | Missouri Baptist Outpatient Center-Sunset Hills | Sunset Hills | Missouri |
United States | Cancer Care Specialists of Illinois-Swansea | Swansea | Illinois |
United States | Memorial and Saint Elizabeth's Health Care Services LLP | Swansea | Illinois |
United States | Flower Hospital | Sylvania | Ohio |
United States | Franciscan Research Center-Northwest Medical Plaza | Tacoma | Washington |
United States | Northwest Medical Specialties PLLC | Tacoma | Washington |
United States | Saint Joseph Health System-Tawas City | Tawas City | Michigan |
United States | Rocky Mountain Cancer Centers-Thornton | Thornton | Colorado |
United States | The Toledo Hospital/Toledo Children's Hospital | Toledo | Ohio |
United States | Saint Francis Hospital and Medical Center - Topeka | Topeka | Kansas |
United States | Smilow Cancer Hospital-Torrington Care Center | Torrington | Connecticut |
United States | Munson Medical Center | Traverse City | Michigan |
United States | Dayton Physicians LLC-Upper Valley | Troy | Ohio |
United States | Upper Valley Medical Center | Troy | Ohio |
United States | Gene Upshaw Memorial Tahoe Forest Cancer Center | Truckee | California |
United States | Smilow Cancer Hospital Care Center-Trumbull | Trumbull | Connecticut |
United States | Vince Lombardi Cancer Clinic-Two Rivers | Two Rivers | Wisconsin |
United States | UPMC Uniontown Hospital Radiation Oncology | Uniontown | Pennsylvania |
United States | Carle Cancer Center | Urbana | Illinois |
United States | The Carle Foundation Hospital | Urbana | Illinois |
United States | Faxton-Saint Luke's Healthcare | Utica | New York |
United States | Northbay Cancer Center | Vacaville | California |
United States | Sutter Cancer Centers Radiation Oncology Services-Vacaville | Vacaville | California |
United States | South Georgia Medical Center/Pearlman Cancer Center | Valdosta | Georgia |
United States | Sutter Solano Medical Center/Cancer Center | Vallejo | California |
United States | Inspira Medical Center Vineland | Vineland | New Jersey |
United States | Ridgeview Medical Center | Waconia | Minnesota |
United States | Advanced Breast Care Center PLLC | Warren | Michigan |
United States | Bhadresh Nayak MD PC-Warren | Warren | Michigan |
United States | Great Lakes Cancer Management Specialists-Macomb Professional Building | Warren | Michigan |
United States | Macomb Hematology Oncology PC | Warren | Michigan |
United States | Michigan Breast Specialists-Warren | Warren | Michigan |
United States | Saint John Macomb-Oakland Hospital | Warren | Michigan |
United States | UPMC Washington Hospital Radiation Oncology | Washington | Pennsylvania |
United States | Smilow Cancer Hospital-Waterbury Care Center | Waterbury | Connecticut |
United States | Aurora Cancer Care-Waukesha | Waukesha | Wisconsin |
United States | Aspirus Regional Cancer Center | Wausau | Wisconsin |
United States | Marshfield Clinic-Wausau Center | Wausau | Wisconsin |
United States | Aurora Cancer Care-Milwaukee West | Wauwatosa | Wisconsin |
United States | Cancer Center of Kansas - Wellington | Wellington | Kansas |
United States | Aurora West Allis Medical Center | West Allis | Wisconsin |
United States | Saint Mary's Oncology/Hematology Associates of West Branch | West Branch | Michigan |
United States | Chester County Hospital | West Chester | Pennsylvania |
United States | Mercy Medical Center-West Lakes | West Des Moines | Iowa |
United States | Saint Ann's Hospital | Westerville | Ohio |
United States | Diagnostic and Treatment Center | Weston | Wisconsin |
United States | Marshfield Clinic - Weston Center | Weston | Wisconsin |
United States | University of Kansas Hospital-Westwood Cancer Center | Westwood | Kansas |
United States | Associates In Womens Health | Wichita | Kansas |
United States | Cancer Center of Kansas - Wichita | Wichita | Kansas |
United States | Cancer Center of Kansas-Wichita Medical Arts Tower | Wichita | Kansas |
United States | Via Christi Regional Medical Center | Wichita | Kansas |
United States | UPMC Susquehanna | Williamsport | Pennsylvania |
United States | Rice Memorial Hospital | Willmar | Minnesota |
United States | Christiana Care Health System-Wilmington Hospital | Wilmington | Delaware |
United States | Southeastern Medical Oncology Center-Wilson | Wilson | North Carolina |
United States | Winchester Hospital | Winchester | Massachusetts |
United States | Cancer Center of Kansas - Winfield | Winfield | Kansas |
United States | Aspirus UW Cancer Center | Wisconsin Rapids | Wisconsin |
United States | Marshfield Clinic - Wisconsin Rapids Center | Wisconsin Rapids | Wisconsin |
United States | Inspira Medical Center Woodbury | Woodbury | New Jersey |
United States | Minnesota Oncology Hematology PA-Woodbury | Woodbury | Minnesota |
United States | Kaiser Permanente-Woodland Hills | Woodland Hills | California |
United States | Fairview Lakes Medical Center | Wyoming | Minnesota |
United States | Metro Health Hospital | Wyoming | Michigan |
United States | WellSpan Health-York Cancer Center | York | Pennsylvania |
United States | WellSpan Health-York Hospital | York | Pennsylvania |
United States | Rush-Copley Healthcare Center | Yorkville | Illinois |
United States | Huron Gastroenterology PC | Ypsilanti | Michigan |
United States | IHA Hematology Oncology Consultants-Ann Arbor | Ypsilanti | Michigan |
United States | Genesis Healthcare System Cancer Care Center | Zanesville | Ohio |
Lead Sponsor | Collaborator |
---|---|
SWOG Cancer Research Network | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in Copy Number Alterations in MET, EGFR, and HER2, Analyzed Using Fluorescence in Situ Hybridization | For each of these markers, a one-sample t-test (or Wilcoxon signed-rank test) will be used to test the null hypothesis that the absolute difference between the copy number after progression and the copy number in the pre-treatment specimen (or an appropriate transformation of the difference, determined after exploratory data analysis) is not equal to zero. | Baseline up to 3 years (after disease progression) | |
Other | Change in the Ratio of Sensitizing EGFR Mutation to EGFR T790 Mutation | To evaluate if EGFRs/EGFR T790M is lower at progression than in pre-treatment specimens among patients with results available for pre-treatment and progression, a one-sample t-test (or Wilcoxon signed-rank test) will be used to test the null hypothesis that the difference between the progression ratio and the pre-treatment ratio (or an appropriate transformation of the difference, determined after exploratory data analysis) is greater than zero in favor of the alternative that the difference is less than zero. | Baseline up to 3 years (at progression) | |
Other | EGFR Immunohistochemistry H-score | To evaluate the hypothesis that H-score positive status at baseline is associated with absolute difference in PFS (and OS) among patients randomized to receive afatinib dimaleate monotherapy a test of interaction will be performed at the 1-sided 20% level. | Baseline | |
Other | Levels of Circulating Tumor Markers | Tumor marker levels over time will be evaluated using a linear mixed model for continuous markers and using generalized estimating equations for binary markers. A landmark analysis will be used to evaluate the correlation between post-randomization biomarker values and PFS and OS (from the landmark timepoint) using a Cox proportional hazards model. | Up to 3 years | |
Other | Presence of de Novo EGFR T790M Mutation or Other Molecular Alterations | To evaluate if the presence of de novo T790M mutation is associated with primary resistance to afatinib dimaleate, PFS and OS will be compared between T790M mutation positive and negative patients randomized to the afatinib dimaleate monotherapy arm using a log-rank test.. | Baseline | |
Other | Ratio of Sensitizing EGFR Mutation to EGFR T790 Mutation | To evaluate if the ratio of EGFR sensitizing mutation to EGFR T790M mutation (EGFRs/EGFR T790M) among patients with T790M is predictive for afatinib dimaleate monotherapy, analyses will be performed in a similar fashion to the evaluation of T790M among patients with measurable T790M (which defines T790M). Cox regression will be used to assess the predictive association of the ratio in the afatinib dimaleate monotherapy arm with both OS and PFS | Up to 3 years | |
Primary | 2-year Overall Survival Rate | Percentage of participants still alive 2 years post registration.
KM estimate at 2 years is presented, Overall Survival assessed for a total of 3 years in order to calculate value. |
Up to 3 years post registration | |
Primary | Progression-Free Survival | From date of registration to date of first documentation of progression or symptomatic deterioration or death due to any cause.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of appropriate diameters of target measurable lesions over smallest sum observed, as well as an absolute increase of at least 0.5 cm. Unequivocal progression of non-measurable disease in the opinion of treating physician. Appearance of any new lesion/site. Death due to disease without prior documentation of progression and without symptomatic deterioration. |
up to 3 years post registration | |
Secondary | Response Rates | Percentage of participants with confirmed and unconfirmed, partial response and complete response to treatment Response Evaluation Criteria in Solid Tumors Criteria (RECIST 1.1).
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of appropriate diameters of all target measurable lesions; Overall Response (OR) = CR + PR. |
Up to 3 years | |
Secondary | Time to Treatment Discontinuation | From date of registration to date of discontinuation of treatment or death due to any cause | up to 3 years post-registration | |
Secondary | Time to Treatment Failure | From date of registration to date of first documentation of progression or symptomatic deterioration, early discontinuation of treatment, or death due to any cause. | assessed up to 3 years post registration | |
Secondary | Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Routine Adverse Events are reported by CTCAE4.0. For serious adverse event reporting, we updated from CTCAE4.0 to CTCAE5.0. . Only adverse events that are possibly, probably or definitely related to study drug are reported. | Duration of treatment and follow up until death or 3 years post registration |
Status | Clinical Trial | Phase | |
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