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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01708954
Other study ID # NCI-2012-01938
Secondary ID NCI-2012-01938EC
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date February 13, 2013
Est. completion date March 7, 2025

Study information

Verified date March 2024
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This randomized phase II trial studies how well giving erlotinib hydrochloride and cabozantinib-s-malate alone or in combination works as second or third line therapy in treating patient with stage IV non-small cell lung cancer. Erlotinib hydrochloride and cabozantinib-s-malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving erlotinib hydrochloride together with cabozantinib-s-malate is more effective than erlotinib hydrochloride or cabozantinib-s-malate alone in treating non-small cell lung cancer.


Description:

PRIMARY OBJECTIVES: I. To compare the progression-free survival (PFS) associated with patients treated with erlotinib (erlotinib hydrochloride) versus (vs) erlotinib plus cabozantinib (cabozantinib-s-malate). II. To compare the PFS associated with patients treated with erlotinib vs cabozantinib. SECONDARY OBJECTIVES: I. To evaluate overall survival in the three treatment arms. II. To evaluate best objective response rate in the three treatment arms. III. To define the toxicity associated with each regimen. IV. To conduct correlative science studies that will help to select predictive biomarkers of response to therapy, including mesenchymal-epidermal transition (MET) expression and potentially other tissue biomarkers, plasma biomarkers, and bone scans. OUTLINE: Patients are randomized to 1 of 3 treatment arms. ARM A (erlotinib): Patients receive erlotinib orally (PO) daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. ARM B (cabozantinib): Patients receive cabozantinib PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. ARM C (erlotinib+cabozantinib): Patients receive erlotinib as patients in Arm A and cabozantinib as patients in Arm B. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. ARM Z: Patients achieving disease progression in Arm A or Arm B may receive erlotinib and cabozantinib as patients in Arm C. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 125
Est. completion date March 7, 2025
Est. primary completion date August 14, 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Criteria: - Tumor with a sensitizing mutation in epidermal growth factor receptor (EGFR), defined as follows: - EGFR mutation testing of tumor has been performed and did not demonstrate an EGFR tyrosine kinase inhibitor sensitizing mutation; at minimum, testing for EGFR exon 19 deletion and exon 21 L858R mutations must have been included; OR - EGFR mutation testing has been attempted and is inconclusive (for example, due to lack of sufficient deoxyribonucleic acid [DNA] yield); OR - EGFR mutation status is unknown but tumor is positive for at least one alternative driver mutation, i.e: Kirsten rat sarcoma viral oncogene homolog (KRAS) mutation, v-raf murine sarcoma viral oncogene homolog B (BRAF) mutation, human epidermal growth factor receptor 2 (HER2) mutation, ret proto-oncogene (RET) rearrangement/fusion, or one not listed following approval by the study chair prior to registration Inclusion Criteria: - INCLUSION CRITERIA STEP 1: - Cytologically or histologically confirmed non-small cell lung carcinoma (NSCLC) - Predominant non-squamous histology (patients with NSCLC not otherwise specified [NOS] are eligible); mixed tumors will be categorized by the predominant cell type; if small cell elements are present the patient is ineligible - Stage IV disease (includes M1a, M1b, or recurrent disease), according to the 7th edition of the lung cancer TNM classification system - Patients must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 criteria; baseline measurements and evaluation of all sites of disease must be obtained within 4 weeks prior to registration - Prior to registration, the investigator/site must confirm that sufficient pathology material representative of patient's cancer is available for submission for MET immunohistochemical (IHC) testing - Patients must have received one or two lines of prior chemotherapy (first line platinum-doublet based chemotherapy plus switch maintenance chemotherapy counts as one line of therapy); prior adjuvant chemotherapy for early stage disease does not count as one line of therapy if 12 months or greater elapsed between completion of adjuvant therapy and initiation of first-line systemic therapy; if less than 12 months elapsed, adjuvant chemotherapy counts as one line of therapy - Any prior chemotherapy (based on administration schedule) must have been completed in greater than or equal to the time frames specified in the protocol - Patients must have discontinued treatment with any other type of investigational agent >= 4 weeks prior to registration - Patients must have recovered to baseline or Common Terminology Criteria for Adverse Events (CTCAE) v 4.0 =< grade 1 from toxicity due to all prior therapies except alopecia and other non-clinically significant adverse events (AEs) - Patients with no known brain metastasis at baseline must have baseline brain imaging within 12 weeks prior to study registration not demonstrating brain metastases; patients with brain metastases at baseline must have baseline brain imagining within 4 weeks prior to study registration and meet all of the specific criteria for brain mets listed in the protocol - Radiation related toxicities must have resolved to =< grade 1 prior to registration - Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status between 0-2 - Patients must have an anticipated life expectancy greater than 3 months - Acceptable bone marrow, renal and hepatic function within 2 weeks prior to registration as defined in the protocol - Patients must have corrected QT interval calculated by the Fridericia formula (QTcF) =< 500 ms within 28 days before registration - Patients must be able to swallow tablets - INCLUSION CRITERIA STEP 2: - Patients must have met all eligibility requirements for Step 1 at time of registration to Step 1 to be eligible for Step 2 - Patients must have radiographic progressive disease per RECIST v1.1 criteria after >= 2 courses of therapy on Arm A or Arm B - Patients must be registered to Step 2 within 4 weeks of the last dose of treatment administration from Step 1 - Patients must have an ECOG performance status between 0-2 - Patients must have recovered to baseline (pre-Step 1) or CTCAE version 4.0 <= grade 1 from toxicity due to all prior therapies except alopecia and other non-clinically significant AEs Exclusion Criteria: - EXCLUSION CRITERIA STEP 1: - Patients without sufficient pathology material representative of the patient's cancer (tumor block or 10 unstained slides) - Prior erlotinib, other EGFR tyrosine kinase inhibitor therapy, vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor therapy, Met tyrosine kinase inhibitor therapy, or Met monoclonal antibody (MetMAb); prior antibody therapy such as bevacizumab or cetuximab is allowed with a washout period depending on dosing interval and investigational nature - Prior radiation therapy to the thoracic cavity, abdomen, or pelvis within 3 months prior to registration, to bone or brain metastasis within 14 days prior to registration, or to any other site within 28 days prior to registration - History of the following: Clinically-significant gastrointestinal (GI) bleeding within 6 months prior to registration; Hemoptysis of >= 0.5 teaspoon (2.5 mL) of red blood within 3 months prior to registration; Any other signs indicative of pulmonary hemorrhage within 3 months prior to registration - Radiographic or other evidence of the following within 28 days prior to registration: • Tumor invading the GI tract (esophagus, stomach, small or large bowel, rectum or anus), or any evidence of endotracheal or endobronchial tumor; Cavitating pulmonary lesion(s); Tumor in contact with, invading or encasing any major blood vessels - Psychiatric illness/social situations that would limit compliance with study requirements - History of major thrombotic events (deep vein thrombosis [DVT] or pulmonary embolism [PE]) within 6 months prior to registration - Concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or warfarin-related agents, heparin, low molecular weight heparin (LMWH), thrombin or Factor Xa inhibitors, or antiplatelet agents (e.g., clopidogrel). (low dose aspirin [=< 81 mg/day] and prophylactic LMWH are permitted) - Concomitant treatment of strong cytochrome P450 3A4 (CYP3A4) inducers (e.g., dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital, and St. John's wort) - Cardiovascular disorders including: Congestive heart failure (CHF): New York Heart Association (NYHA) class III (moderate) or class IV (severe) at the time of screening; - Concurrent uncontrolled hypertension; Any history of congenital long QT syndrome; Any of the following within 6 months prior to registration: - Unstable angina pectoris - Clinically-significant cardiac arrhythmias - Stroke (including transient ischemic attack [TIA], or other ischemic event) - Myocardial infarction - GI disorders particularly those associated with a high risk of perforation or fistula formation specified in the protocol - Other disorders associated with a high risk of fistula formation including percutaneous endoscopic gastrostomy (PEG) tube placement within 3 months prior to registration - Uncontrolled, significant, intercurrent or recent illness - Prior malignancy within 2 years prior to registration which required systemic treatment or is currently active - Pregnant or breast-feeding - Patients with known human immunodeficiency virus (HIV) disease taking antiretroviral therapy - Known chronic active hepatitis B - EXCLUSION CRITERIA (STEP 2): - Intervening anticancer treatment or major surgical procedure(s) between Step 1 and Step 2, except palliative radiation to the bone finishing >= 2 weeks prior to registration to Step 2 - Central nervous system (CNS) progression; patients with stable CNS disease are allowed - Intercurrent illness or disease complication that the investigator believes would limit the ability to safely tolerate the combination of erlotinib and cabozantinib

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Cabozantinib S-malate
Given PO
Erlotinib Hydrochloride
Given PO
Other:
Laboratory Biomarker Analysis
Correlative studies

Locations

Country Name City State
United States Bixby Medical Center Adrian Michigan
United States Hickman Cancer Center Adrian Michigan
United States Summa Health System - Akron Campus Akron Ohio
United States University of New Mexico Cancer Center Albuquerque New Mexico
United States Mary Greeley Medical Center Ames Iowa
United States McFarland Clinic - Ames Ames Iowa
United States Michigan Cancer Research Consortium NCORP Ann Arbor Michigan
United States Trinity Health Saint Joseph Mercy Hospital Ann Arbor Ann Arbor Michigan
United States Emory Saint Joseph's Hospital Atlanta Georgia
United States Emory University Hospital/Winship Cancer Institute Atlanta Georgia
United States Rush - Copley Medical Center Aurora Illinois
United States The Medical Center of Aurora Aurora Colorado
United States Dell Seton Medical Center at The University of Texas Austin Texas
United States Greater Baltimore Medical Center Baltimore Maryland
United States Ochsner Health Center-Summa Baton Rouge Louisiana
United States Strecker Cancer Center-Belpre Belpre Ohio
United States Sanford Joe Lueken Cancer Center Bemidji Minnesota
United States Constantinou, Costas L MD (UIA Investigator) Bettendorf Iowa
United States Illinois CancerCare-Bloomington Bloomington Illinois
United States IU Health Bloomington Bloomington Indiana
United States OSF Saint Joseph Medical Center Bloomington Illinois
United States Saint Alphonsus Cancer Care Center-Boise Boise Idaho
United States McFarland Clinic - Boone Boone Iowa
United States Boulder Community Hospital Boulder Colorado
United States Rocky Mountain Cancer Centers-Boulder Boulder Colorado
United States Toledo Clinic Cancer Centers-Bowling Green Bowling Green Ohio
United States Montefiore Medical Center - Moses Campus Bronx New York
United States Montefiore Medical Center-Weiler Hospital Bronx New York
United States Bryn Mawr Hospital Bryn Mawr Pennsylvania
United States Fairview Ridges Hospital Burnsville Minnesota
United States Cooper Hospital University Medical Center Camden New Jersey
United States Cleveland Clinic Mercy Hospital Canton Ohio
United States Illinois CancerCare-Canton Canton Illinois
United States Saint Francis Medical Center Cape Girardeau Missouri
United States Illinois CancerCare-Carthage Carthage Illinois
United States Mercy Hospital Cedar Rapids Iowa
United States Oncology Associates at Mercy Medical Center Cedar Rapids Iowa
United States Centralia Oncology Clinic Centralia Illinois
United States Cancer Center of Kansas - Chanute Chanute Kansas
United States West Virginia University Charleston Division Charleston West Virginia
United States Northwestern University Chicago Illinois
United States Adena Regional Medical Center Chillicothe Ohio
United States Marshfield Clinic-Chippewa Center Chippewa Falls Wisconsin
United States Case Western Reserve University Cleveland Ohio
United States MetroHealth Medical Center Cleveland Ohio
United States Mercy Cancer Center-West Lakes Clive Iowa
United States Mission Cancer and Blood - West Des Moines Clive Iowa
United States Penrose-Saint Francis Healthcare Colorado Springs Colorado
United States Rocky Mountain Cancer Centers-Penrose Colorado Springs Colorado
United States Columbus NCI Community Oncology Research Program Columbus Ohio
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 Carle at The Riverfront Danville Illinois
United States Geisinger Medical Center Danville Pennsylvania
United States Beaumont Hospital - Dearborn Dearborn Michigan
United States Atlanta VA Medical Center Decatur Georgia
United States Cancer Care Specialists of Illinois - Decatur Decatur Illinois
United States Decatur Memorial Hospital Decatur Illinois
United States Heartland Cancer Research NCORP 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 Colorado Blood Cancer Institute Denver Colorado
United States Porter Adventist Hospital Denver Colorado
United States Presbyterian - Saint Lukes Medical Center - Health One Denver Colorado
United States Rocky Mountain Cancer Centers-Midtown Denver Colorado
United States Rocky Mountain Cancer Centers-Rose Denver Colorado
United States Rose Medical Center Denver Colorado
United States SCL Health Saint Joseph Hospital Denver Colorado
United States Western States Cancer Research NCORP Denver Colorado
United States Iowa Lutheran Hospital Des Moines Iowa
United States Iowa Methodist Medical Center Des Moines Iowa
United States Iowa-Wide Oncology Research Coalition NCORP Des Moines Iowa
United States Mercy Medical Center - Des Moines Des Moines Iowa
United States Mission Cancer and Blood - Des Moines Des Moines Iowa
United States Mission Cancer and Blood - Laurel Des Moines Iowa
United States Ascension Saint John Hospital Detroit Michigan
United States Cancer Center of Kansas - Dodge City Dodge City Kansas
United States Doylestown Hospital Doylestown Pennsylvania
United States Mercy Medical Center Durango Colorado
United States Veterans Adminstration New Jersey Health Care System East Orange New Jersey
United States HSHS Sacred Heart Hospital Eau Claire Wisconsin
United States Marshfield Clinic Cancer Center at Sacred Heart 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 Elkhart Clinic Elkhart Indiana
United States Elkhart General Hospital Elkhart Indiana
United States Michiana Hematology Oncology PC-Elkhart Elkhart Indiana
United States Christiana Care - Union Hospital Elkton Maryland
United States Mountain Blue Cancer Care Center - Swedish Englewood Colorado
United States Swedish Medical Center Englewood Colorado
United States UPMC Hillman Cancer Center Erie Erie Pennsylvania
United States OSF Saint Francis Hospital and Medical Group Escanaba Michigan
United States Illinois CancerCare-Eureka Eureka Illinois
United States NorthShore University HealthSystem-Evanston Hospital Evanston Illinois
United States Sanford Broadway Medical Center Fargo North Dakota
United States Sanford Clinic North-Fargo Fargo North Dakota
United States Sanford Roger Maris Cancer Center Fargo North Dakota
United States Genesys Hurley Cancer Institute Flint Michigan
United States Hurley Medical Center Flint Michigan
United States Cancer Center of Kansas - Fort Scott Fort Scott Kansas
United States Fredericksburg Oncology Inc Fredericksburg Virginia
United States Unity Hospital Fridley Minnesota
United States Illinois CancerCare-Galesburg Galesburg Illinois
United States NorthShore University HealthSystem-Glenbrook Hospital Glenview Illinois
United States Mountain Blue Cancer Care Center Golden Colorado
United States Banner North Colorado Medical Center Greeley Colorado
United States Green Bay Oncology at Saint Vincent Hospital Green Bay Wisconsin
United States Green Bay Oncology Limited at Saint Mary's Hospital Green Bay Wisconsin
United States Saint Vincent Hospital Cancer Center at Saint Mary's Green Bay Wisconsin
United States Saint Vincent Hospital Cancer Center Green Bay Green Bay Wisconsin
United States Rocky Mountain Cancer Centers-Greenwood Village Greenwood Village Colorado
United States Hackensack University Medical Center Hackensack New Jersey
United States Smilow Cancer Hospital Care Center at Saint Francis Hartford Connecticut
United States Ingalls Memorial Hospital Harvey Illinois
United States Geisinger Medical Center-Cancer Center Hazleton Hazleton Pennsylvania
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-Southeast Henderson Henderson Nevada
United States GenesisCare USA - Henderson Henderson Nevada
United States Las Vegas Cancer Center-Henderson Henderson Nevada
United States Penn State Milton S Hershey Medical Center Hershey Pennsylvania
United States Hematology Oncology Associates of Illinois-Highland Park Highland Park Illinois
United States NorthShore University HealthSystem-Highland Park Hospital Highland Park Illinois
United States Hutchinson Area Health Care Hutchinson Minnesota
United States Cancer Center of Kansas-Independence Independence Kansas
United States Indiana University/Melvin and Bren Simon Cancer Center Indianapolis Indiana
United States IU Health Central Indiana Cancer Centers-East Indianapolis Indiana
United States Green Bay Oncology - Iron Mountain Iron Mountain Michigan
United States Allegiance Health Jackson Michigan
United States McFarland Clinic - Jefferson Jefferson Iowa
United States University of Wisconsin Carbone Cancer Center - Johnson Creek Johnson Creek Wisconsin
United States Borgess Medical Center Kalamazoo Michigan
United States Bronson Methodist Hospital Kalamazoo Michigan
United States West Michigan Cancer Center Kalamazoo Michigan
United States Presence Saint Mary's Hospital Kankakee Illinois
United States Illinois CancerCare-Kewanee Clinic Kewanee Illinois
United States Cancer Center of Kansas-Kingman Kingman Kansas
United States Community Howard Regional Health Kokomo Indiana
United States IU Health La Porte Hospital La Porte Indiana
United States Rocky Mountain Cancer Centers-Lakewood Lakewood Colorado
United States Saint Anthony Hospital Lakewood Colorado
United States Fairfield Medical Center Lancaster Ohio
United States Lancaster General Hospital Lancaster Pennsylvania
United States University of Michigan Health - Sparrow Lansing Lansing Michigan
United States Memorial Medical Center - Las Cruces Las Cruces New Mexico
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 GenesisCare USA - Fort Apache Las Vegas Nevada
United States GenesisCare USA - Las Vegas Las Vegas Nevada
United States GenesisCare USA - Vegas Tenaya 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 Research Foundation NCORP Las Vegas Nevada
United States OptumCare Cancer Care at 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 University Medical Center of Southern Nevada Las Vegas Nevada
United States Lawrence Memorial Hospital Lawrence Kansas
United States Beebe Medical Center Lewes Delaware
United States Geisinger Medical Oncology-Lewisburg Lewisburg Pennsylvania
United States Cancer Center of Kansas-Liberal Liberal Kansas
United States AMG Libertyville - Oncology Libertyville Illinois
United States Lima Memorial Hospital Lima Ohio
United States Saint Rita's Medical Center Lima Ohio
United States Nebraska Cancer Research Center Lincoln Nebraska
United States Littleton Adventist Hospital Littleton Colorado
United States Trinity Health Saint Mary Mercy Livonia Hospital Livonia Michigan
United States Rocky Mountain Cancer Centers-Sky Ridge Lone Tree Colorado
United States Sky Ridge Medical Center Lone Tree Colorado
United States Monmouth Medical Center Long Branch New Jersey
United States Longmont United Hospital Longmont Colorado
United States Rocky Mountain Cancer Centers-Longmont Longmont Colorado
United States Banner McKee Medical Center Loveland Colorado
United States Illinois CancerCare-Macomb Macomb Illinois
United States Atrium Health Navicent Macon Georgia
United States SSM Health Dean Medical Group - South Madison Campus Madison Wisconsin
United States University of Wisconsin Carbone Cancer Center - University Hospital Madison Wisconsin
United States Cancer Center of Kansas-Manhattan Manhattan Kansas
United States Holy Family Memorial Hospital Manitowoc Wisconsin
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 Bay Area Medical Center Marinette Wisconsin
United States McFarland Clinic - Marshalltown Marshalltown Iowa
United States Marshfield Medical Center Marshfield Wisconsin
United States Marshfield Medical Center-Marshfield Marshfield Wisconsin
United States Mercy Medical Center - North Iowa Mason City Iowa
United States Carle Physician Group-Mattoon/Charleston Mattoon Illinois
United States Toledo Clinic Cancer Centers-Maumee Maumee Ohio
United States Cancer Center of Kansas - McPherson McPherson Kansas
United States University of Miami Miller School of Medicine-Sylvester Cancer Center Miami Florida
United States Franciscan Saint Anthony Health-Michigan City Michigan City Indiana
United States Woodland Cancer Care Center Michigan City Indiana
United States Medical College of Wisconsin 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 Michiana Hematology Oncology PC-Mishawaka Mishawaka Indiana
United States Saint Joseph Regional Medical Center-Mishawaka Mishawaka Indiana
United States Memorial Medical Center Modesto California
United States Garneau, Stewart C MD (UIA Investigator) Moline Illinois
United States Porubcin, Michael MD (UIA Investigator) Moline Illinois
United States Spector, David MD (UIA Investigator) Moline Illinois
United States Trinity Medical Center Moline Illinois
United States Illinois CancerCare-Monmouth Monmouth Illinois
United States Mercy Memorial Hospital Monroe Michigan
United States Toledo Clinic Cancer Centers-Monroe Monroe Michigan
United States Community Hospital of Monterey Peninsula Monterey California
United States West Virginia University Healthcare Morgantown West Virginia
United States Morristown Medical Center Morristown New Jersey
United States Virtua Memorial Mount Holly New Jersey
United States Knox Community Hospital Mount Vernon Ohio
United States IU Health Ball Memorial Hospital Muncie Indiana
United States The Hospital of Central Connecticut New Britain Connecticut
United States Ochsner Baptist Medical Center New Orleans Louisiana
United States Ochsner Medical Center Jefferson New Orleans Louisiana
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 Christiana Gynecologic Oncology LLC 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 Radiation Oncology Newark Ohio
United States Rutgers New Jersey Medical School Newark New Jersey
United States Cancer Center of Kansas - Newton Newton Kansas
United States Illinois Cancer Specialists-Niles Niles Illinois
United States Carle Cancer Institute Normal Normal Illinois
United States ProHealth Oconomowoc Memorial Hospital Oconomowoc Wisconsin
United States Saint Vincent Hospital Cancer Center at Oconto Falls Oconto Falls Wisconsin
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 Missouri Valley Cancer Consortium Omaha Nebraska
United States Saint Charles Hospital Oregon Ohio
United States Toledo Clinic Cancer Centers-Oregon Oregon Ohio
United States Illinois CancerCare-Ottawa Clinic Ottawa Illinois
United States Ottawa Regional Hospital and Healthcare Center Ottawa Illinois
United States Stanford Cancer Institute Palo Alto Palo Alto California
United States VA Palo Alto Health Care System Palo Alto California
United States Paoli Memorial Hospital Paoli Pennsylvania
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 Illinois CancerCare-Pekin Pekin Illinois
United States OSF Saint Francis Radiation Oncology at Pekin Pekin Illinois
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 Proctor Hospital Peoria Illinois
United States Illinois CancerCare-Peru Peru Illinois
United States Illinois Valley Hospital Peru Illinois
United States Einstein Medical Center Philadelphia Philadelphia Pennsylvania
United States Thomas Jefferson University Hospital Philadelphia Pennsylvania
United States Michiana Hematology Oncology PC-Plymouth Plymouth Indiana
United States Trinity Health Saint Joseph Mercy Oakland Hospital Pontiac Michigan
United States Lake Huron Medical Center Port Huron Michigan
United States Southern Ohio Medical Center Portsmouth Ohio
United States Geisinger Cancer Services-Pottsville Pottsville Pennsylvania
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 Eisenhower Medical Center Rancho Mirage California
United States Beebe Health Campus Rehoboth Beach Delaware
United States Ascension Saint Mary's Hospital Rhinelander Wisconsin
United States Saint Mary's Hospital Rhinelander Wisconsin
United States Marshfield Medical Center-Rice Lake Rice Lake Wisconsin
United States North Memorial Medical Health Center Robbinsdale Minnesota
United States Swedish American Hospital Rockford Illinois
United States UW Health Carbone Cancer Center Rockford Rockford Illinois
United States Ascension Saint Mary's Hospital Saginaw Michigan
United States Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center Saint Joseph Michigan
United States Corewell Health Lakeland Hospitals - Saint Joseph Hospital Saint Joseph Michigan
United States Metro Minnesota Community Oncology Research Consortium Saint Louis Park Minnesota
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 Cancer Center of Kansas - Salina Salina Kansas
United States Cancer Therapy and Research Center at The UT Health Science Center at San Antonio San Antonio Texas
United States University of Texas Health Science Center at San Antonio San Antonio Texas
United States Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Savannah Georgia
United States Guthrie Medical Group PC-Robert Packer Hospital Sayre Pennsylvania
United States Mayo Clinic in Arizona Scottsdale Arizona
United States TidalHealth Nanticoke / Allen Cancer Center Seaford Delaware
United States Saint Francis Regional Medical Center Shakopee Minnesota
United States HSHS Saint Nicholas Hospital Sheboygan Wisconsin
United States Mercy Medical Center-Sioux City Sioux City Iowa
United States Saint Luke's Regional Medical Center Sioux City Iowa
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 Hematology Oncology Associates of Illinois - Skokie Skokie Illinois
United States Memorial Hospital of South Bend South Bend Indiana
United States Michiana Hematology Oncology PC-South Bend South Bend Indiana
United States Northern Indiana Cancer Research Consortium South Bend Indiana
United States South Bend Clinic South Bend Indiana
United States Memorial Medical Center Springfield Illinois
United States Springfield Regional Medical Center Springfield Ohio
United States Geisinger Medical Group State College Pennsylvania
United States Ascension Saint Michael's Hospital Stevens Point Wisconsin
United States Lakeview Hospital Stillwater Minnesota
United States Stony Brook University Medical Center Stony Brook New York
United States Green Bay Oncology - Sturgeon Bay Sturgeon Bay Wisconsin
United States Overlook Hospital Summit New Jersey
United States ProMedica Flower Hospital Sylvania Ohio
United States Mercy Hospital of Tiffin Tiffin Ohio
United States Mercy Health - Saint Anne Hospital Toledo Ohio
United States Mercy Health - Saint Vincent Hospital Toledo Ohio
United States ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital Toledo Ohio
United States Toledo Clinic Cancer Centers-Toledo Toledo Ohio
United States Toledo Community Hospital Oncology Program CCOP Toledo Ohio
United States University of Toledo Toledo Ohio
United States University of Texas Health Science Center at Tyler Tyler Texas
United States Carle Cancer Center Urbana Illinois
United States The Carle Foundation Hospital Urbana Illinois
United States Inspira Medical Center Vineland Vineland New Jersey
United States Ridgeview Medical Center Waconia Minnesota
United States Saint John Macomb-Oakland Hospital Warren Michigan
United States ProHealth Waukesha Memorial Hospital Waukesha Wisconsin
United States Marshfield Clinic-Wausau Center Wausau Wisconsin
United States Fulton County Health Center Wauseon Ohio
United States Cancer Center of Kansas - Wellington Wellington Kansas
United States Mercy Medical Center-West Lakes West Des Moines Iowa
United States Saint Ann's Hospital Westerville Ohio
United States Ascension Saint Clare's Hospital Weston Wisconsin
United States Diagnostic and Treatment Center Weston Wisconsin
United States Marshfield Medical Center - Weston Weston Wisconsin
United States Michiana Hematology Oncology PC-Westville Westville Indiana
United States SCL Health Lutheran Medical Center Wheat Ridge Colorado
United States Wheeling Hospital/Schiffler Cancer Center Wheeling West Virginia
United States Dickstein Cancer Treatment Center White Plains New York
United States Ascension Via Christi Hospitals Wichita Wichita 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 Wichita NCI Community Oncology Research Program Wichita Kansas
United States Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre Pennsylvania
United States Rice Memorial Hospital Willmar Minnesota
United States Christiana Care Health System-Wilmington Hospital Wilmington Delaware
United States Cancer Center of Kansas - Winfield Winfield Kansas
United States Aspirus Cancer Care - Wisconsin Rapids Wisconsin Rapids Wisconsin
United States Marshfield Clinic - Wisconsin Rapids Center Wisconsin Rapids Wisconsin
United States Minnesota Oncology Hematology PA-Woodbury Woodbury Minnesota
United States Lankenau Medical Center Wynnewood Pennsylvania
United States Main Line Health NCORP Wynnewood Pennsylvania
United States WellSpan Health-York Hospital York Pennsylvania
United States York Hospital York Maine
United States Rush-Copley Healthcare Center Yorkville Illinois
United States Genesis Healthcare System Cancer Care Center Zanesville Ohio

Sponsors (1)

Lead Sponsor Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression-free Survival (PFS) PFS is defined as the time from randomization to documented disease progression or death from any cause, whichever occurred first. Patients who had not experienced an event of interest by the time of analysis were censored at the date of last disease assessment. Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry, up to 5 years
Secondary Overall Survival (OS) OS is defined as the time from randomization to death from any cause or date of last known alive. Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry, up to 5 years
Secondary Proportion of Patients With Objective Response Objective response is defined as complete response (CR) or partial response (PR) evaluated using RECIST v 1.1. CR is defined as disappearance of all lesions and any pathological lymph nodes must have reduction in short axis to < 10 mm. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions and persistence of one or more non-target lesion(s). Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry, up to 5 years
Secondary Proportion of Patients With MET Positivity Submission of archival tissue for central MET IHC testing was required for this study, and total MET IHC testing was conducted at the Brigham and Women's Hospital using the c-Met clone CVD13 (arabbit polyclonal). Membranous and cytoplasmic staining were individually scored, and positivity was declared if MET was expressed in either the membrane or cytoplasm. Assessed at baseline
Secondary Proportion of Patients With Worst Grade Toxicities of Grade 3 or Higher Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
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Active, not recruiting NCT03600701 - Atezolizumab and Cobimetinib in Treating Patients With Metastatic, Recurrent, or Refractory Non-small Cell Lung Cancer Phase 2
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Active, not recruiting NCT04837716 - Ensartinib, Carboplatin, Pemetrexed and Bevacizumab for the Treatment of Stage IIIC or IV or Recurrent ALK-Positive Non-small Cell Lung Cancer Phase 1
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