Erlotinib Hydrochloride and Cabozantinib-s-Malate Alone or in Combination as Second or Third Line Therapy in Treating Patients With Stage IV Non-small Cell Lung Cancer
A Randomized Phase II Trial of Erlotinib, Cabozantinib, or Erlotinib Plus Cabozantinib as 2nd or 3rd Line Therapy in Patients With EGFR Wild-Type NSCLC
6 other identifiers
interventional
125
1 country
357
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2013
Longer than P75 for phase_2
357 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 15, 2012
CompletedFirst Posted
Study publicly available on registry
October 17, 2012
CompletedStudy Start
First participant enrolled
February 13, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 14, 2015
CompletedResults Posted
Study results publicly available
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2027
ExpectedMay 29, 2026
March 1, 2026
2.5 years
October 15, 2012
October 6, 2016
May 28, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Overall Survival (OS)
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
Proportion of Patients With Objective Response
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
Proportion of Patients With MET Positivity
Assessed at baseline
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
Study Arms (4)
Arm A (erlotinib)
EXPERIMENTALPatients receive erlotinib PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Arm B (cabozantinib)
EXPERIMENTALPatients 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)
EXPERIMENTALPatients 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 (erlotinib+cabozantinib; step II)
EXPERIMENTALPatients 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.
Interventions
Given PO
Given PO
Correlative studies
Eligibility Criteria
You may qualify if:
- 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
- +6 more criteria
You may not qualify if:
- 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
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (357)
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259, United States
Memorial Medical Center
Modesto, California, 95355, United States
Community Hospital of Monterey Peninsula
Monterey, California, 93940, United States
Stanford Cancer Institute Palo Alto
Palo Alto, California, 94304, United States
VA Palo Alto Health Care System
Palo Alto, California, 94304, United States
Eisenhower Medical Center
Rancho Mirage, California, 92270, United States
The Medical Center of Aurora
Aurora, Colorado, 80012, United States
Boulder Community Foothills Hospital
Boulder, Colorado, 80303, United States
Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado, 80304, United States
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, 80907, United States
Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado, 80907, United States
AdventHealth Porter
Denver, Colorado, 80210, United States
Colorado Blood Cancer Institute
Denver, Colorado, 80218, United States
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, 80218, United States
Rocky Mountain Cancer Centers-Midtown
Denver, Colorado, 80218, United States
Saint Joseph Hospital - Cancer Centers of Colorado
Denver, Colorado, 80218, United States
Rocky Mountain Cancer Centers-Rose
Denver, Colorado, 80220, United States
Rose Medical Center
Denver, Colorado, 80220, United States
Western States Cancer Research NCORP
Denver, Colorado, 80222, United States
Mercy Medical Center
Durango, Colorado, 81301, United States
Mountain Blue Cancer Care Center - Swedish
Englewood, Colorado, 80113, United States
Swedish Medical Center
Englewood, Colorado, 80113, United States
Mountain Blue Cancer Care Center
Golden, Colorado, 80401, United States
Banner North Colorado Medical Center
Greeley, Colorado, 80631, United States
Rocky Mountain Cancer Centers-Greenwood Village
Greenwood Village, Colorado, 80111, United States
CommonSpirit Saint Anthony Hospital Cancer Center
Lakewood, Colorado, 80228, United States
Rocky Mountain Cancer Centers-Lakewood
Lakewood, Colorado, 80228, United States
AdventHealth Littleton
Littleton, Colorado, 80122, United States
Rocky Mountain Cancer Centers-Sky Ridge
Lone Tree, Colorado, 80124, United States
Sky Ridge Medical Center
Lone Tree, Colorado, 80124, United States
Longmont United Hospital
Longmont, Colorado, 80501, United States
Rocky Mountain Cancer Centers-Longmont
Longmont, Colorado, 80501, United States
Banner North Colorado Medical Center - Loveland Campus
Loveland, Colorado, 80539, United States
AdventHealth Parker
Parker, Colorado, 80138, United States
Rocky Mountain Cancer Centers-Parker
Parker, Colorado, 80138, United States
Saint Mary Corwin Medical Center
Pueblo, Colorado, 81004, United States
Rocky Mountain Cancer Centers - Pueblo
Pueblo, Colorado, 81008, United States
Intermountain Health Lutheran Hospital
Wheat Ridge, Colorado, 80401, United States
Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut, 06105, United States
The Hospital of Central Connecticut
New Britain, Connecticut, 06050, United States
Beebe Medical Center
Lewes, Delaware, 19958, United States
Delaware Clinical and Laboratory Physicians PA
Newark, Delaware, 19713, United States
Helen F Graham Cancer Center
Newark, Delaware, 19713, United States
Medical Oncology Hematology Consultants PA
Newark, Delaware, 19713, United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware, 19718, United States
Beebe Health Campus
Rehoboth Beach, Delaware, 19971, United States
TidalHealth Nanticoke / Allen Cancer Center
Seaford, Delaware, 19973, United States
Christiana Care Health System-Wilmington Hospital
Wilmington, Delaware, 19801, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136, United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342, United States
Atlanta VA Medical Center
Decatur, Georgia, 30033, United States
Atrium Health Navicent
Macon, Georgia, 31201, United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, 31405, United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706, United States
Rush-Copley Medical Center
Aurora, Illinois, 60504, United States
OSF Saint Joseph Medical Center
Bloomington, Illinois, 61701, United States
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704, United States
Illinois CancerCare-Canton
Canton, Illinois, 61520, United States
Illinois CancerCare-Carthage
Carthage, Illinois, 62321, United States
Centralia Oncology Clinic
Centralia, Illinois, 62801, United States
Northwestern University
Chicago, Illinois, 60611, United States
Carle at The Riverfront
Danville, Illinois, 61832, United States
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526, United States
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
Heartland Cancer Research NCORP
Decatur, Illinois, 62526, United States
Carle Physician Group-Effingham
Effingham, Illinois, 62401, United States
Crossroads Cancer Center
Effingham, Illinois, 62401, United States
Illinois CancerCare-Eureka
Eureka, Illinois, 61530, United States
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, 60201, United States
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401, United States
NorthShore University HealthSystem-Glenbrook Hospital
Glenview, Illinois, 60026, United States
Ingalls Memorial Hospital
Harvey, Illinois, 60426, United States
Hematology Oncology Associates of Illinois-Highland Park
Highland Park, Illinois, 60035, United States
NorthShore University HealthSystem-Highland Park Hospital
Highland Park, Illinois, 60035, United States
Presence Saint Mary's Hospital
Kankakee, Illinois, 60901, United States
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, 61443, United States
AMG Libertyville - Oncology
Libertyville, Illinois, 60048, United States
Illinois CancerCare-Macomb
Macomb, Illinois, 61455, United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938, United States
Garneau, Stewart C MD (UIA Investigator)
Moline, Illinois, 61265, United States
Porubcin, Michael MD (UIA Investigator)
Moline, Illinois, 61265, United States
Spector, David MD (UIA Investigator)
Moline, Illinois, 61265, United States
Trinity Medical Center
Moline, Illinois, 61265, United States
Illinois CancerCare-Monmouth
Monmouth, Illinois, 61462, United States
Illinois Cancer Specialists-Niles
Niles, Illinois, 60714, United States
Carle Cancer Institute Normal
Normal, Illinois, 61761, United States
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350, United States
Ottawa Regional Hospital and Healthcare Center
Ottawa, Illinois, 61350, United States
Illinois CancerCare-Pekin
Pekin, Illinois, 61554, United States
OSF Saint Francis Radiation Oncology at Pekin
Pekin, Illinois, 61554, United States
Proctor Hospital
Peoria, Illinois, 61614, United States
Illinois CancerCare-Peoria
Peoria, Illinois, 61615, United States
Methodist Medical Center of Illinois
Peoria, Illinois, 61636, United States
OSF Saint Francis Medical Center
Peoria, Illinois, 61637, United States
Illinois CancerCare-Peru
Peru, Illinois, 61354, United States
Illinois Valley Hospital
Peru, Illinois, 61354, United States
Illinois CancerCare-Princeton
Princeton, Illinois, 61356, United States
Swedish American Hospital
Rockford, Illinois, 61104, United States
UW Health Carbone Cancer Center Rockford
Rockford, Illinois, 61114, United States
Hematology Oncology Associates of Illinois - Skokie
Skokie, Illinois, 60076, United States
Springfield Memorial Hospital
Springfield, Illinois, 62781, United States
Carle Cancer Center
Urbana, Illinois, 61801, United States
The Carle Foundation Hospital
Urbana, Illinois, 61801, United States
Rush-Copley Healthcare Center
Yorkville, Illinois, 60560, United States
IU Health Bloomington
Bloomington, Indiana, 47408, United States
Elkhart Clinic
Elkhart, Indiana, 46514-2098, United States
Michiana Hematology Oncology PC-Elkhart
Elkhart, Indiana, 46514, United States
Elkhart General Hospital
Elkhart, Indiana, 46515, United States
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202, United States
IU Health Central Indiana Cancer Centers-East
Indianapolis, Indiana, 46219, United States
Community Howard Regional Health
Kokomo, Indiana, 46904, United States
IU Health La Porte Hospital
La Porte, Indiana, 46350, United States
Franciscan Saint Anthony Health-Michigan City
Michigan City, Indiana, 46360, United States
Woodland Cancer Care Center
Michigan City, Indiana, 46360, United States
Michiana Hematology Oncology PC-Mishawaka
Mishawaka, Indiana, 46545, United States
Saint Joseph Regional Medical Center-Mishawaka
Mishawaka, Indiana, 46545, United States
IU Health Ball Memorial Hospital
Muncie, Indiana, 47303, United States
Michiana Hematology Oncology PC-Plymouth
Plymouth, Indiana, 46563, United States
Memorial Hospital of South Bend
South Bend, Indiana, 46601, United States
South Bend Clinic
South Bend, Indiana, 46617, United States
Northern Indiana Cancer Research Consortium
South Bend, Indiana, 46628, United States
Michiana Hematology Oncology PC-Westville
Westville, Indiana, 46391, United States
Mary Greeley Medical Center
Ames, Iowa, 50010, United States
McFarland Clinic - Ames
Ames, Iowa, 50010, United States
Constantinou, Costas L MD (UIA Investigator)
Bettendorf, Iowa, 52722, United States
McFarland Clinic - Boone
Boone, Iowa, 50036, United States
Mercy Hospital
Cedar Rapids, Iowa, 52403, United States
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, 52403, United States
Mercy Cancer Center-West Lakes
Clive, Iowa, 50325, United States
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa, 50325, United States
Iowa Methodist Medical Center
Des Moines, Iowa, 50309, United States
Iowa-Wide Oncology Research Coalition NCORP
Des Moines, Iowa, 50309, United States
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa, 50309, United States
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314, United States
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa, 50314, United States
Iowa Lutheran Hospital
Des Moines, Iowa, 50316, United States
McFarland Clinic - Jefferson
Jefferson, Iowa, 50129, United States
McFarland Clinic - Marshalltown
Marshalltown, Iowa, 50158, United States
Mercy Medical Center - North Iowa
Mason City, Iowa, 50401, United States
Siouxland Regional Cancer Center
Sioux City, Iowa, 51101, United States
Mercy Medical Center-Sioux City
Sioux City, Iowa, 51102, United States
Saint Luke's Regional Medical Center
Sioux City, Iowa, 51104, United States
Mercy Medical Center-West Lakes
West Des Moines, Iowa, 50266, United States
Cancer Center of Kansas - Chanute
Chanute, Kansas, 66720, United States
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, 67801, United States
Cancer Center of Kansas - El Dorado
El Dorado, Kansas, 67042, United States
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, 66701, United States
Cancer Center of Kansas-Independence
Independence, Kansas, 67301, United States
Cancer Center of Kansas-Kingman
Kingman, Kansas, 67068, United States
Lawrence Memorial Hospital
Lawrence, Kansas, 66044, United States
Cancer Center of Kansas-Liberal
Liberal, Kansas, 67905, United States
Cancer Center of Kansas-Manhattan
Manhattan, Kansas, 66502, United States
Cancer Center of Kansas - McPherson
McPherson, Kansas, 67460, United States
Cancer Center of Kansas - Newton
Newton, Kansas, 67114, United States
Cancer Center of Kansas - Parsons
Parsons, Kansas, 67357, United States
Cancer Center of Kansas - Pratt
Pratt, Kansas, 67124, United States
Cancer Center of Kansas - Salina
Salina, Kansas, 67401, United States
Cancer Center of Kansas - Wellington
Wellington, Kansas, 67152, United States
Associates In Womens Health
Wichita, Kansas, 67208, United States
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, 67208, United States
Ascension Via Christi Hospitals Wichita
Wichita, Kansas, 67214, United States
Cancer Center of Kansas - Wichita
Wichita, Kansas, 67214, United States
Wichita NCI Community Oncology Research Program
Wichita, Kansas, 67214, United States
Cancer Center of Kansas - Winfield
Winfield, Kansas, 67156, United States
Ochsner Health Center-Summa
Baton Rouge, Louisiana, 70809, United States
Ochsner Baptist Medical Center
New Orleans, Louisiana, 70115, United States
Ochsner Medical Center Jefferson
New Orleans, Louisiana, 70121, United States
York Hospital
York Village, Maine, 03909, United States
Greater Baltimore Medical Center
Baltimore, Maryland, 21204, United States
Christiana Care - Union Hospital
Elkton, Maryland, 21921, United States
Bixby Medical Center
Adrian, Michigan, 49221, United States
Hickman Cancer Center
Adrian, Michigan, 49221, United States
Michigan Cancer Research Consortium NCORP
Ann Arbor, Michigan, 48106, United States
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, 48106, United States
Corewell Health Dearborn Hospital
Dearborn, Michigan, 48124, United States
Henry Ford Health Saint John Hospital
Detroit, Michigan, 48236, United States
OSF Saint Francis Hospital and Medical Group
Escanaba, Michigan, 49829, United States
Genesys Hurley Cancer Institute
Flint, Michigan, 48503, United States
Hurley Medical Center
Flint, Michigan, 48503, United States
Allegiance Health
Jackson, Michigan, 49201, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007, United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007, United States
Beacon Kalamazoo
Kalamazoo, Michigan, 49048, United States
University of Michigan Health - Sparrow Lansing
Lansing, Michigan, 48912, United States
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, 48154, United States
Mercy Memorial Hospital
Monroe, Michigan, 48162, United States
Toledo Clinic Cancer Centers-Monroe
Monroe, Michigan, 48162, United States
Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan, 48341, United States
Lake Huron Medical Center
Port Huron, Michigan, 48060, United States
MyMichigan Medical Center Saginaw
Saginaw, Michigan, 48601, United States
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
Saint Joseph, Michigan, 49085, United States
Corewell Health Lakeland Hospitals - Saint Joseph Hospital
Saint Joseph, Michigan, 49085, United States
Henry Ford Health Warren Hospital
Warren, Michigan, 48093, United States
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, 56601, United States
Fairview Ridges Hospital
Burnsville, Minnesota, 55337, United States
Mercy Hospital
Coon Rapids, Minnesota, 55433, United States
Fairview Southdale Hospital
Edina, Minnesota, 55435, United States
Unity Hospital
Fridley, Minnesota, 55432, United States
Hutchinson Area Health Care
Hutchinson, Minnesota, 55350, United States
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, 55109, United States
Saint John's Hospital - Healtheast
Maplewood, Minnesota, 55109, United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415, United States
New Ulm Medical Center
New Ulm, Minnesota, 56073, United States
North Memorial Medical Health Center
Robbinsdale, Minnesota, 55422, United States
Metro Minnesota Community Oncology Research Consortium
Saint Louis Park, Minnesota, 55416, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416, United States
Regions Hospital
Saint Paul, Minnesota, 55101, United States
United Hospital
Saint Paul, Minnesota, 55102, United States
Saint Francis Regional Medical Center
Shakopee, Minnesota, 55379, United States
Lakeview Hospital
Stillwater, Minnesota, 55082, United States
Ridgeview Medical Center
Waconia, Minnesota, 55387, United States
Rice Memorial Hospital
Willmar, Minnesota, 56201, United States
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota, 55125, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703, United States
Nebraska Cancer Research Center
Lincoln, Nebraska, 68510, United States
Missouri Valley Cancer Consortium
Omaha, Nebraska, 68106, United States
Alegent Health Immanuel Medical Center
Omaha, Nebraska, 68122, United States
Alegent Health Bergan Mercy Medical Center
Omaha, Nebraska, 68124, United States
Alegent Health Lakeside Hospital
Omaha, Nebraska, 68130, United States
Creighton University Medical Center
Omaha, Nebraska, 68131, United States
Cancer and Blood Specialists-Henderson
Henderson, Nevada, 89052, United States
Comprehensive Cancer Centers of Nevada - Henderson
Henderson, Nevada, 89052, United States
Las Vegas Cancer Center-Henderson
Henderson, Nevada, 89052, United States
Comprehensive Cancer Centers of Nevada-Southeast Henderson
Henderson, Nevada, 89074, United States
Oncology Las Vegas - Henderson
Henderson, Nevada, 89074, United States
University Medical Center of Southern Nevada
Las Vegas, Nevada, 89102, United States
Cancer and Blood Specialists-Shadow
Las Vegas, Nevada, 89106, United States
Radiation Oncology Centers of Nevada Central
Las Vegas, Nevada, 89106, United States
HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
Las Vegas, Nevada, 89109, United States
HealthCare Partners Medical Group Oncology/Hematology-San Martin
Las Vegas, Nevada, 89113, United States
Radiation Oncology Centers of Nevada Southeast
Las Vegas, Nevada, 89119, United States
Nevada Cancer Research Foundation NCORP
Las Vegas, Nevada, 89120, United States
Cancer Therapy and Integrative Medicine
Las Vegas, Nevada, 89121, United States
Cancer and Blood Specialists-Tenaya
Las Vegas, Nevada, 89128, United States
Comprehensive Cancer Centers of Nevada - Northwest
Las Vegas, Nevada, 89128, United States
HealthCare Partners Medical Group Oncology/Hematology-Tenaya
Las Vegas, Nevada, 89128, United States
Oncology Las Vegas - Tenaya
Las Vegas, Nevada, 89128, United States
Comprehensive Cancer Centers of Nevada-Summerlin
Las Vegas, Nevada, 89144, United States
Las Vegas Cancer Center-Medical Center
Las Vegas, Nevada, 89148-2405, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89148, United States
HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
Las Vegas, Nevada, 89149, United States
Comprehensive Cancer Centers of Nevada - Central Valley
Las Vegas, Nevada, 89169, United States
OptumCare Cancer Care at Fort Apache
Las Vegas, Nevada, 89183, United States
Cooper Hospital University Medical Center
Camden, New Jersey, 08103, United States
Veterans Adminstration New Jersey Health Care System
East Orange, New Jersey, 07018-1095, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Monmouth Medical Center
Long Branch, New Jersey, 07740, United States
Morristown Medical Center
Morristown, New Jersey, 07960, United States
Virtua Memorial
Mount Holly, New Jersey, 08060, United States
Rutgers New Jersey Medical School
Newark, New Jersey, 07101, United States
Overlook Hospital
Summit, New Jersey, 07902, United States
Inspira Medical Center Vineland
Vineland, New Jersey, 08360, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106, United States
Memorial Medical Center-Las Cruces
Las Cruces, New Mexico, 88011, United States
Stony Brook University Medical Center
Stony Brook, New York, 11794, United States
Montefiore Medical Center-Weiler Hospital
The Bronx, New York, 10461, United States
Montefiore Medical Center - Moses Campus
The Bronx, New York, 10467, United States
Dickstein Cancer Treatment Center
White Plains, New York, 10601, United States
Sanford Broadway Medical Center
Fargo, North Dakota, 58122, United States
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122, United States
Summa Health System - Akron Campus
Akron, Ohio, 44304, United States
Strecker Cancer Center-Belpre
Belpre, Ohio, 45714, United States
Toledo Clinic Cancer Centers-Bowling Green
Bowling Green, Ohio, 43402, United States
Cleveland Clinic Mercy Hospital
Canton, Ohio, 44708, United States
Adena Regional Medical Center
Chillicothe, Ohio, 45601, United States
Case Western Reserve University
Cleveland, Ohio, 44106, United States
MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
Columbus Oncology and Hematology Associates Inc
Columbus, Ohio, 43214, United States
Riverside Methodist Hospital
Columbus, Ohio, 43214, United States
Columbus NCI Community Oncology Research Program
Columbus, Ohio, 43215, United States
Grant Medical Center
Columbus, Ohio, 43215, United States
The Mark H Zangmeister Center
Columbus, Ohio, 43219, United States
Mount Carmel Health Center West
Columbus, Ohio, 43222, United States
Doctors Hospital
Columbus, Ohio, 43228, United States
Delaware Health Center-Grady Cancer Center
Delaware, Ohio, 43015, United States
Delaware Radiation Oncology
Delaware, Ohio, 43015, United States
Grady Memorial Hospital
Delaware, Ohio, 43015, United States
Fairfield Medical Center
Lancaster, Ohio, 43130, United States
Saint Rita's Medical Center
Lima, Ohio, 45801, United States
Lima Memorial Hospital
Lima, Ohio, 45804, United States
Marietta Memorial Hospital
Marietta, Ohio, 45750, United States
Toledo Clinic Cancer Centers-Maumee
Maumee, Ohio, 43537, United States
Knox Community Hospital
Mount Vernon, Ohio, 43050, United States
Licking Memorial Hospital
Newark, Ohio, 43055, United States
Newark Radiation Oncology
Newark, Ohio, 43055, United States
Saint Charles Hospital
Oregon, Ohio, 43616, United States
Toledo Clinic Cancer Centers-Oregon
Oregon, Ohio, 43616, United States
Southern Ohio Medical Center
Portsmouth, Ohio, 45662, United States
Springfield Regional Medical Center
Springfield, Ohio, 45504, United States
ProMedica Flower Hospital
Sylvania, Ohio, 43560, United States
Mercy Hospital of Tiffin
Tiffin, Ohio, 44883, United States
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
Toledo, Ohio, 43606, United States
Mercy Health - Saint Vincent Hospital
Toledo, Ohio, 43608, United States
University of Toledo
Toledo, Ohio, 43614, United States
Toledo Community Hospital Oncology Program CCOP
Toledo, Ohio, 43617, United States
Mercy Health - Saint Anne Hospital
Toledo, Ohio, 43623, United States
Toledo Clinic Cancer Centers-Toledo
Toledo, Ohio, 43623, United States
Fulton County Health Center
Wauseon, Ohio, 43567, United States
Saint Ann's Hospital
Westerville, Ohio, 43081, United States
Genesis Healthcare System Cancer Care Center
Zanesville, Ohio, 43701, United States
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, 19010, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
Doylestown Hospital
Doylestown, Pennsylvania, 18901, United States
UPMC Hillman Cancer Center Erie
Erie, Pennsylvania, 16505, United States
Geisinger Medical Center-Cancer Center Hazleton
Hazleton, Pennsylvania, 18201, United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033-0850, United States
Lancaster General Hospital
Lancaster, Pennsylvania, 17602, United States
Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania, 17837, United States
Paoli Memorial Hospital
Paoli, Pennsylvania, 19301, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Einstein Medical Center Philadelphia
Philadelphia, Pennsylvania, 19141, United States
Geisinger Cancer Services-Pottsville
Pottsville, Pennsylvania, 17901, United States
Guthrie Medical Group PC-Robert Packer Hospital
Sayre, Pennsylvania, 18840, United States
Geisinger Medical Group
State College, Pennsylvania, 16801, United States
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, 18711, United States
Lankenau Medical Center
Wynnewood, Pennsylvania, 19096, United States
Main Line Health NCORP
Wynnewood, Pennsylvania, 19096, United States
WellSpan Health-York Hospital
York, Pennsylvania, 17403, United States
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, 57104, United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134, United States
Dell Seton Medical Center at The University of Texas
Austin, Texas, 78701, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
University of Texas Health Science Center at Tyler
Tyler, Texas, 75708, United States
Fredericksburg Oncology Inc
Fredericksburg, Virginia, 22401, United States
West Virginia University Charleston Division
Charleston, West Virginia, 25304, United States
West Virginia University Healthcare
Morgantown, West Virginia, 26506, United States
Wheeling Hospital/Schiffler Cancer Center
Wheeling, West Virginia, 26003, United States
Marshfield Clinic-Chippewa Center
Chippewa Falls, Wisconsin, 54729, United States
HSHS Sacred Heart Hospital
Eau Claire, Wisconsin, 54701, United States
Marshfield Clinic Cancer Center at Sacred Heart
Eau Claire, Wisconsin, 54701, United States
Green Bay Oncology at Saint Vincent Hospital
Green Bay, Wisconsin, 54301-3526, United States
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, 54301, United States
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, 54303, United States
University of Wisconsin Carbone Cancer Center - Johnson Creek
Johnson Creek, Wisconsin, 53038, United States
SSM Health Dean Medical Group - South Madison Campus
Madison, Wisconsin, 53715, United States
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, 53792, United States
Holy Family Memorial Hospital
Manitowoc, Wisconsin, 54221, United States
Bay Area Medical Center
Marinette, Wisconsin, 54143, United States
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449, United States
Marshfield Medical Center
Marshfield, Wisconsin, 54449, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Marshfield Medical Center - Minocqua
Minocqua, Wisconsin, 54548, United States
Cancer Center of Western Wisconsin
New Richmond, Wisconsin, 54017, United States
ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, 53066, United States
Saint Vincent Hospital Cancer Center at Oconto Falls
Oconto Falls, Wisconsin, 54154, United States
Aspirus Cancer Care - James Beck Cancer Center
Rhinelander, Wisconsin, 54501, United States
Saint Mary's Hospital
Rhinelander, Wisconsin, 54501, United States
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, 54868, United States
HSHS Saint Nicholas Hospital
Sheboygan, Wisconsin, 53081, United States
Aspirus Cancer Care - Stevens Point
Stevens Point, Wisconsin, 54481, United States
ProHealth Waukesha Memorial Hospital
Waukesha, Wisconsin, 53188, United States
Marshfield Clinic-Wausau Center
Wausau, Wisconsin, 54401, United States
Marshfield Medical Center - Weston
Weston, Wisconsin, 54476, United States
Aspirus Cancer Care - Wisconsin Rapids
Wisconsin Rapids, Wisconsin, 54494, United States
Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids, Wisconsin, 54494, United States
Related Publications (1)
Neal JW, Dahlberg SE, Wakelee HA, Aisner SC, Bowden M, Huang Y, Carbone DP, Gerstner GJ, Lerner RE, Rubin JL, Owonikoko TK, Stella PJ, Steen PD, Khalid AA, Ramalingam SS; ECOG-ACRIN 1512 Investigators. Erlotinib, cabozantinib, or erlotinib plus cabozantinib as second-line or third-line treatment of patients with EGFR wild-type advanced non-small-cell lung cancer (ECOG-ACRIN 1512): a randomised, controlled, open-label, multicentre, phase 2 trial. Lancet Oncol. 2016 Dec;17(12):1661-1671. doi: 10.1016/S1470-2045(16)30561-7. Epub 2016 Nov 4.
PMID: 27825638DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Statistician
- Organization
- ECOG-ACRIN Statistical Office
Study Officials
- PRINCIPAL INVESTIGATOR
Joel W Neal
ECOG-ACRIN Cancer Research Group
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 15, 2012
First Posted
October 17, 2012
Study Start
February 13, 2013
Primary Completion
August 14, 2015
Study Completion (Estimated)
March 31, 2027
Last Updated
May 29, 2026
Results First Posted
December 1, 2016
Record last verified: 2026-03