Stage IIIB Non-Small Cell Lung Cancer Clinical Trial
Official title:
Randomized Phase II Trial of Concurrent Chemoradiotherapy +/- Metformin HCL in Locally Advanced NSCLC
Verified date | June 2023 |
Source | NRG Oncology |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This randomized phase II trial studies how well chemotherapy and radiation therapy given with or without metformin hydrochloride works in treating patients with stage III non-small cell lung cancer. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Metformin hydrochloride may shrink tumors and keep them from coming back. It is not yet known whether chemotherapy and radiation therapy is more effective when given with or without metformin hydrochloride in treating stage III non-small cell lung cancer.
Status | Active, not recruiting |
Enrollment | 170 |
Est. completion date | April 16, 2025 |
Est. primary completion date | April 16, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Pathologically (histologically or cytologically) proven diagnosis of stage IIIA or IIIB non-small cell lung cancer within 84 days of registration; eligible histologies include adenocarcinoma, adenosquamous, large cell carcinoma, squamous carcinoma, non-lobar and non-diffuse bronchoalveolar cell carcinoma or non-small cell lung cancer not otherwise specified) - Patients must have measurable disease - Patients must have unresectable disease, be medically inoperable, or unwilling to undergo surgical management - Appropriate stage for protocol entry, including no distant metastases, based upon the following minimum diagnostic workup: - History/physical examination, including documentation of height, weight, body surface area, and vital signs, within 30 days prior to registration - Computed tomography (CT) with IV contrast or magnetic resonance imaging (MRI) imaging (if CT scan with contrast is medically contraindicated) of the lung and upper abdomen through the adrenal glands, required within 45 days prior to registration (recommended within 30 days prior to registration - MRI of the brain with contrast (or CT with contrast if MRI is medically contraindicated) within 45 days prior to registration; note: the use of intravenous contrast is required for the MRI or CT; an MRI without contrast is only permitted if the patient has a contrast allergy - Whole-body fludeoxyglucose (FDG)-positron emission tomography (PET)/CT required within 45 days prior to registration (recommended within 30 days prior to registration; note: patients do not need to have a separate CT of the chest and upper abdomen with contrast if PET/CT imaging includes a high quality CT with contrast - Zubrod performance status 0-1 - Absolute neutrophil count (ANC) >= 1,500 cells/mm^3 - Complete blood count(CBC)/differential obtained within 14 days prior to registration on study, with adequate bone marrow function defined as follows: - Absolute neutrophil count (ANC) = 1,500 cells/mm3 - Platelets >= 100,000 cells/mm^3 - Hemoglobin >= 8.0 g/dl (note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 8.0 g/dl is acceptable) - Adequate renal function within 14 days prior to registration, defined as serum creatinine within normal institutional limits or creatinine clearance must be at least 60 ml/min; - Adequate hepatic function within 14 days prior to registration, defined as total bilirubin = 1.5 x upper limit of normal (ULN) for the institution and alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase = 2.5 x ULN for the institution; - Fasting blood glucose = 125 mg/dL within 14 days prior to registration; - Serum albumin > 3.0 g/dl within 14 days prior to registration; - For women of childbearing potential, a serum pregnancy test within 72 hours prior to registration; - Patients with post-obstructive pneumonia are eligible provided they no longer require intravenous antibiotics at registration; - Patients must be at least 3 weeks from prior thoracotomy (if performed); - If a pleural effusion is present, the following criteria must be met at registration to exclude malignant involvement (incurable M1a disease): - When pleural fluid is visible on both the CT scan and on a chest x-ray, a pleuracentesis is required to confirm that the pleural fluid is cytologically negative; - Effusions that are minimal (i.e. not visible under ultrasound guidance) and that are too small to safely tap are eligible. - Women of childbearing potential and male participants must practice adequate contraception throughout the study; Exclusion Criteria: - Patients with mixed small cell and non-small cell histologies - Patients with distant metastasis - Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible) - Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable - Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields - Patients currently using metformin (metformin hydrochloride), other oral hypoglycemic agents or insulin - Patients with any history of allergic reaction to paclitaxel or other taxanes or carboplatin - Patients with a history of chronic kidney disease or lactic acidosis - Patients with >= 10% weight loss within the past month - Severe, active co-morbidity, defined as follows: - Diagnosis of type I or type II diabetes mellitus - Uncontrolled neuropathy >= grade 2 regardless of cause - Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months - Transmural myocardial infarction within the last 6 months - Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration - Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration - Severe hepatic disease, defined as a diagnosis of Child-Pugh class B or C hepatic disease - Human immunodeficiency virus (HIV) positive with cluster of differentiation (CD)4 count < 200 cells/microliter; note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count >= 200 cells/microliter within 30 days prior to registration; note also that HIV testing is not required for eligibility for this protocol - End-stage renal disease (ie, on dialysis or dialysis has been recommended) - Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception |
Country | Name | City | State |
---|---|---|---|
Canada | Jewish General Hospital | Montreal | Quebec |
Canada | Allan Blair Cancer Centre | Regina | Saskatchewan |
Canada | Saskatoon Cancer Centre | Saskatoon | Saskatchewan |
Israel | Chaim Sheba Medical Center | Tel Hashomer | |
United States | The Cancer Center of Hawaii-Pali Momi | 'Aiea | Hawaii |
United States | Abington Memorial Hospital | Abington | Pennsylvania |
United States | New Mexico Oncology Hematology Consultants | Albuquerque | New Mexico |
United States | University of New Mexico Cancer Center | Albuquerque | New Mexico |
United States | AnMed Health Cancer Center | Anderson | South Carolina |
United States | Northwest Community Hospital | Arlington Heights | Illinois |
United States | Piedmont Hospital | Atlanta | Georgia |
United States | Sutter Cancer Centers Radiation Oncology Services-Auburn | Auburn | California |
United States | University of Colorado Hospital | Aurora | Colorado |
United States | University of Maryland/Greenebaum Cancer Center | Baltimore | Maryland |
United States | Louisiana Hematology Oncology Associates LLC | Baton Rouge | Louisiana |
United States | LSU Health Baton Rouge-North Clinic | Baton Rouge | Louisiana |
United States | Mary Bird Perkins Cancer Center | Baton Rouge | Louisiana |
United States | Our Lady of the Lake Physicians Group - Medical Oncology | Baton Rouge | Louisiana |
United States | UHHS-Chagrin Highlands Medical Center | Beachwood | Ohio |
United States | UM Upper Chesapeake Medical Center | Bel Air | Maryland |
United States | Gaston Hematology and Oncology Associates-Belmont | Belmont | North Carolina |
United States | Sanford Joe Lueken Cancer Center | Bemidji | Minnesota |
United States | Central Vermont Medical Center/National Life Cancer Treatment | Berlin | Vermont |
United States | Billings Clinic Cancer Center | Billings | Montana |
United States | Sanford Bismarck Medical Center | Bismarck | North Dakota |
United States | IU Health Bloomington | Bloomington | Indiana |
United States | Saint Alphonsus Cancer Care Center-Boise | Boise | Idaho |
United States | Boston Medical Center | Boston | Massachusetts |
United States | Harrison Medical Center | Bremerton | Washington |
United States | New York-Presbyterian/Brooklyn Methodist Hospital | Brooklyn | New York |
United States | University of Vermont Medical Center | Burlington | Vermont |
United States | Sutter Cancer Centers Radiation Oncology Services-Cameron Park | Cameron Park | California |
United States | Aultman Health Foundation | Canton | Ohio |
United States | Mercy Medical Center | Canton | Ohio |
United States | Saint Francis Medical Center | Cape Girardeau | Missouri |
United States | Southeast Cancer Center | Cape Girardeau | Missouri |
United States | Eden Hospital Medical Center | Castro Valley | California |
United States | Mercy Hospital | Cedar Rapids | Iowa |
United States | Geauga Hospital | Chardon | Ohio |
United States | John H Stroger Jr Hospital of Cook County | Chicago | Illinois |
United States | Rush University Medical Center | Chicago | Illinois |
United States | Adena Regional Medical Center | Chillicothe | Ohio |
United States | University of Cincinnati/Barrett Cancer Center | Cincinnati | Ohio |
United States | Case Western Reserve University | Cleveland | Ohio |
United States | Cleveland Clinic Cancer Center/Fairview Hospital | Cleveland | Ohio |
United States | Cleveland Clinic Foundation | Cleveland | Ohio |
United States | Penrose-Saint Francis Healthcare | Colorado Springs | Colorado |
United States | UCHealth Memorial Hospital Central | Colorado Springs | Colorado |
United States | John B Amos Cancer Center | Columbus | Georgia |
United States | Mount Carmel Health Center West | Columbus | Ohio |
United States | Ohio State University Comprehensive Cancer Center | 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 | Mary Bird Perkins Cancer Center - Covington | Covington | Louisiana |
United States | Geisinger Medical Center | Danville | Pennsylvania |
United States | Good Samaritan Hospital - Dayton | Dayton | Ohio |
United States | Decatur Memorial Hospital | Decatur | Illinois |
United States | Dekalb Medical Center | Decatur | Georgia |
United States | Henry Ford Hospital | Detroit | Michigan |
United States | Wentworth-Douglass Hospital | Dover | New Hampshire |
United States | Saint Luke's Hospital of Duluth | Duluth | Minnesota |
United States | Northeast Radiation Oncology Center | Dunmore | Pennsylvania |
United States | Fairview-Southdale Hospital | Edina | Minnesota |
United States | Hardin Memorial Hospital | Elizabethtown | Kentucky |
United States | Mercy Cancer Center-Elyria | Elyria | Ohio |
United States | Swedish Medical Center | Englewood | Colorado |
United States | The Regional Cancer Center | Erie | Pennsylvania |
United States | Sanford Roger Maris Cancer Center | Fargo | North Dakota |
United States | Augusta Health Center for Cancer and Blood Disorders | Fishersville | Virginia |
United States | McLaren Cancer Institute-Flint | Flint | Michigan |
United States | Parkview Hospital Randallia | Fort Wayne | Indiana |
United States | Radiation Oncology Associates PC | Fort Wayne | Indiana |
United States | University of Texas Medical Branch | Galveston | Texas |
United States | CaroMont Regional Medical Center | Gastonia | North Carolina |
United States | Gaston Hematology and Oncology Associates | Gastonia | North Carolina |
United States | UM Baltimore Washington Medical Center/Tate Cancer Center | Glen Burnie | Maryland |
United States | Aurora Cancer Care-Grafton | Grafton | Wisconsin |
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 | North Colorado Medical Center | Greeley | Colorado |
United States | Aurora BayCare Medical Center | Green Bay | Wisconsin |
United States | Greenville Health System Cancer Institute-Eastside | Greenville | South Carolina |
United States | Greenville Health System Cancer Institute-Faris | Greenville | South Carolina |
United States | Saint Francis Cancer Center | Greenville | South Carolina |
United States | Self Regional Healthcare | Greenwood | South Carolina |
United States | Gibbs Cancer Center-Pelham | Greer | South Carolina |
United States | Greenville Health System Cancer Institute-Greer | Greer | South Carolina |
United States | Queen's Medical Center | Honolulu | Hawaii |
United States | The Cancer Center of Hawaii-Liliha | Honolulu | Hawaii |
United States | Mary Bird Perkins Cancer Center - Houma | Houma | Louisiana |
United States | M D Anderson Cancer Center | Houston | Texas |
United States | MD Anderson in Katy | Houston | Texas |
United States | The Methodist Hospital System | Houston | Texas |
United States | Cleveland Clinic Cancer Center Independence | Independence | Ohio |
United States | Franciscan Health Indianapolis | Indianapolis | Indiana |
United States | University of Mississippi Medical Center | Jackson | Mississippi |
United States | West Michigan Cancer Center | Kalamazoo | Michigan |
United States | North Kansas City Hospital | 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 | University of Kansas Cancer Center | Kansas City | Kansas |
United States | CHI Health Good Samaritan | Kearney | Nebraska |
United States | Aurora Cancer Care-Kenosha South | Kenosha | Wisconsin |
United States | Kettering Medical Center | Kettering | Ohio |
United States | UC San Diego Moores Cancer Center | La Jolla | California |
United States | McLaren Cancer Institute-Lapeer Region | Lapeer | Michigan |
United States | Lawrence Memorial Hospital | Lawrence | Kansas |
United States | UTMB Cancer Center at Victory Lakes | League City | Texas |
United States | Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire |
United States | The University of Kansas Cancer Center-Lee's Summit | Lee's Summit | Missouri |
United States | Baptist Health Lexington | Lexington | Kentucky |
United States | University of Kentucky/Markey Cancer Center | Lexington | Kentucky |
United States | PeaceHealth Saint John Medical Center | Longview | Washington |
United States | McKee Medical Center | Loveland | Colorado |
United States | Lowell General Hospital | Lowell | Massachusetts |
United States | Bay Area Medical Center | Marinette | Wisconsin |
United States | Marshfield Medical Center-Marshfield | Marshfield | Wisconsin |
United States | Hillcrest Hospital Cancer Center | Mayfield Heights | Ohio |
United States | Community Memorial Hospital | Menomonee Falls | Wisconsin |
United States | UH Seidman Cancer Center at Lake Health Mentor Campus | Mentor | Ohio |
United States | Ascension Columbia Saint Mary's Hospital Ozaukee | Mequon | Wisconsin |
United States | UH Seidman Cancer Center at Southwest General Hospital | Middleburg Heights | Ohio |
United States | Ascension Columbia Saint Mary's Water Tower Medical Commons | Milwaukee | Wisconsin |
United States | Aurora Saint Luke's Medical Center | Milwaukee | Wisconsin |
United States | Medical College of Wisconsin | Milwaukee | Wisconsin |
United States | Zablocki Veterans Administration Medical Center | Milwaukee | Wisconsin |
United States | Abbott-Northwestern Hospital | Minneapolis | Minnesota |
United States | Hennepin County Medical Center | Minneapolis | Minnesota |
United States | Marshfield Clinic-Minocqua Center | Minocqua | Wisconsin |
United States | Community Medical Hospital | Missoula | Montana |
United States | Memorial Medical Center | Modesto | California |
United States | McLaren Cancer Institute-Macomb | Mount Clemens | Michigan |
United States | Virtua Memorial | Mount Holly | New Jersey |
United States | McLaren Cancer Institute-Central Michigan | Mount Pleasant | Michigan |
United States | Good Samaritan Regional Health Center | Mount Vernon | Illinois |
United States | Intermountain Medical Center | Murray | Utah |
United States | Mercy Health Mercy Campus | Muskegon | Michigan |
United States | MD Anderson League City | Nassau Bay | Texas |
United States | Cancer Center of Western Wisconsin | New Richmond | Wisconsin |
United States | Christiana Care Health System-Christiana Hospital | Newark | Delaware |
United States | Newark Radiation Oncology | Newark | Ohio |
United States | Kaiser Permanente Oakland-Broadway | Oakland | California |
United States | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma |
United States | Nebraska Methodist Hospital | Omaha | Nebraska |
United States | University of Nebraska Medical Center | Omaha | Nebraska |
United States | UF Cancer Center at Orlando Health | Orlando | Florida |
United States | University of Kansas Cancer Center-Overland Park | Overland Park | Kansas |
United States | McLaren Cancer Institute-Owosso | Owosso | Michigan |
United States | 21st Century Oncology-Palatka | Palatka | Florida |
United States | University Hospitals Parma Medical Center | Parma | Ohio |
United States | OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center | Pekin | 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 | McLaren Cancer Institute-Northern Michigan | Petoskey | Michigan |
United States | Thomas Jefferson University Hospital | Philadelphia | Pennsylvania |
United States | FirstHealth of the Carolinas-Moore Regional Hospital | Pinehurst | North Carolina |
United States | UPMC-Shadyside Hospital | Pittsburgh | Pennsylvania |
United States | Saint Joseph Mercy Oakland | Pontiac | Michigan |
United States | Southern Ohio Medical Center | Portsmouth | Ohio |
United States | Kootenai Cancer Center | Post Falls | Idaho |
United States | Kaiser Permanente-Rancho Cordova Cancer Center | Rancho Cordova | California |
United States | Marshfield Medical Center-Rice Lake | Rice Lake | Wisconsin |
United States | University of Rochester | Rochester | New York |
United States | Rohnert Park Cancer Center | Rohnert Park | California |
United States | Delbert Day Cancer Institute at PCRMC | Rolla | Missouri |
United States | Sutter Cancer Centers Radiation Oncology Services-Roseville | Roseville | California |
United States | The Permanente Medical Group-Roseville Radiation Oncology | Roseville | California |
United States | William Beaumont Hospital-Royal Oak | Royal Oak | Michigan |
United States | South Sacramento Cancer Center | Sacramento | California |
United States | Sutter Medical Center Sacramento | Sacramento | California |
United States | Norris Cotton Cancer Center-North | Saint Johnsbury | Vermont |
United States | Lakeland Medical Center Saint Joseph | Saint Joseph | Michigan |
United States | Mercy Hospital Saint Louis | Saint Louis | Missouri |
United States | Missouri Baptist Medical Center | Saint Louis | Missouri |
United States | Regions Hospital | Saint Paul | Minnesota |
United States | United Hospital | Saint Paul | Minnesota |
United States | Peninsula Regional Medical Center | Salisbury | Maryland |
United States | UCSF Medical Center-Mount Zion | San Francisco | California |
United States | North Coast Cancer Care | Sandusky | Ohio |
United States | UH Seidman Cancer Center at Firelands Regional Medical Center | Sandusky | Ohio |
United States | Lewis Cancer and Research Pavilion at Saint Joseph's/Candler | Savannah | Georgia |
United States | Memorial Health University Medical Center | Savannah | Georgia |
United States | Maine Medical Center- Scarborough Campus | Scarborough | Maine |
United States | Greenville Health System Cancer Institute-Seneca | Seneca | South Carolina |
United States | Sanford USD Medical Center - Sioux Falls | Sioux Falls | South Dakota |
United States | Kaiser Permanente Cancer Treatment Center | South San Francisco | California |
United States | Greenville Health System Cancer Institute-Spartanburg | Spartanburg | South Carolina |
United States | Spartanburg Medical Center | Spartanburg | South Carolina |
United States | CoxHealth South Hospital | Springfield | Missouri |
United States | Memorial Medical Center | Springfield | Illinois |
United States | Saint Michael's Hospital | Stevens Point | Wisconsin |
United States | Cleveland Clinic Cancer Center Strongsville | Strongsville | Ohio |
United States | MD Anderson in Sugar Land | Sugar Land | Texas |
United States | Aurora Medical Center in Summit | Summit | Wisconsin |
United States | MD Anderson in The Woodlands | The Woodlands | Texas |
United States | Community Medical Center | Toms River | New Jersey |
United States | William Beaumont Hospital - Troy | Troy | Michigan |
United States | Banner University Medical Center - Tucson | Tucson | Arizona |
United States | Lewis and Faye Manderson Cancer Center | Tuscaloosa | Alabama |
United States | Saint Luke's Mountain States Tumor Institute-Twin Falls | Twin Falls | Idaho |
United States | Vince Lombardi Cancer Clinic-Two Rivers | Two Rivers | Wisconsin |
United States | Carle Cancer Center | Urbana | Illinois |
United States | Sutter Cancer Centers Radiation Oncology Services-Vacaville | Vacaville | California |
United States | PeaceHealth Southwest Medical Center | Vancouver | Washington |
United States | Virtua Voorhees | Voorhees | New Jersey |
United States | Aurora West Allis Medical Center | West Allis | Wisconsin |
United States | The Alyce and Elmore Kraemer Cancer Care Center | West Bend | Wisconsin |
United States | University Pointe | West Chester | Ohio |
United States | Reading Hospital | West Reading | Pennsylvania |
United States | UHHS-Westlake Medical Center | Westlake | Ohio |
United States | Diagnostic and Treatment Center | Weston | Wisconsin |
United States | SCL Health Lutheran Medical Center | Wheat Ridge | Colorado |
United States | Wheeling Hospital/Schiffler Cancer Center | Wheeling | West Virginia |
United States | Ascension Via Christi Hospitals Wichita | Wichita | Kansas |
United States | Wesley Medical Center | Wichita | Kansas |
United States | Geisinger Wyoming Valley/Henry Cancer Center | Wilkes-Barre | Pennsylvania |
United States | Rice Memorial Hospital | Willmar | Minnesota |
United States | Aspirus UW Cancer Center | Wisconsin Rapids | Wisconsin |
United States | Cleveland Clinic Wooster Family Health and Surgery Center | Wooster | Ohio |
United States | Lankenau Medical Center | Wynnewood | Pennsylvania |
United States | Genesis Healthcare System Cancer Care Center | Zanesville | Ohio |
Lead Sponsor | Collaborator |
---|---|
NRG Oncology | National Cancer Institute (NCI) |
United States, Canada, Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Participants Alive Without Progression (Progression-free Survival) | Progression is defined per RECIST v1.1 as change in a known lesion(s) meeting one of the following criteria: [1] At least a 20% increase in the sum of the longest diameter of target lesions such that the absolute increase must be > 5 mm. [2] Appearance of =1 new lesions. Progression-free survival time is defined as time from randomization to the date of first progression, death, or last known follow-up (censored). Progression-free survival rates are estimated using the Kaplan-Meier method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. One-year rates are provided. Analysis occurred after 102 progression-free survival events were reported. | From randomization to last follow-up. Maximum follow-up at time of analysis was 47.2 months. | |
Secondary | Percentage of Participants Alive (Overall Survival) | Overall survival time is defined as time from randomization to the date of death from any cause or last known follow-up (censored). Overall survival rates are estimated using the Kaplan-Meier method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. One-year rates are provided. Analysis occurred after 102 progression-free survival events were reported. | From randomization to last follow-up. Maximum follow-up at time of analysis was 47.2 months. | |
Secondary | Percentage of Participants With Local-regional Progression | Local-regional progression (LRP) is defined as progression within the planned treatment volume (PTV) or outside the PTV but within the same lobe(s) of the lung as the primary tumor or in regional lymph nodes. Progression is defined as change in a known lesion(s) meeting one of the following criteria: [1] = 20% increase in the sum of the longest diameter of target lesions such that the absolute increase must be > 5 mm. [2] Appearance of =1 new lesions. LRP time is defined as time from randomization to the date of first LRP, death without LRP (competing risk), or last known follow-up (censored). LRP rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. One-year rates are provided. Analysis occurred after 102 LRP events were reported. | From randomization to last follow-up. Maximum follow-up at time of analysis was 47.2 months. | |
Secondary | Percentage of Participants With Distant Metastases | Distant metastasis (DM) is defined as the appearance of = 1 new lesions at any site (including pleural or pericardial effusion) outside of the following: the planned treatment volume, the same lobe(s) of the lung as the primary tumor, or regional lymph nodes. Time to DM is defined as time from randomization to the date of first DM, death without DM (competing risk), or last known follow-up (censored). DM rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. One-year rates are provided. Analysis occurred after 102 progression-free survival events were reported. | From randomization to last follow-up. Maximum follow-up at time of analysis was 47.2 months. | |
Secondary | Percentage of Participants With Treatment-related Grade 3 or Higher Adverse Events | Adverse events (AE) were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to adverse event. "Treatment-related" is defined definitely, probably, or possibly related to treatment. | From start of treatment to last follow-up. Maximum follow-up at time of analysis was 47.2 months. |
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