Erlotinib Hydrochloride With or Without Bevacizumab in Treating Patients With Stage IV Non-small Cell Lung Cancer With Epidermal Growth Factor Receptor Mutations
NCT ID: NCT01532089
Last Updated: 2020-10-06
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE2
Total Enrollment
88 participants
Study Classification
INTERVENTIONAL
Study Start Date
2012-03-16
Study Completion Date
2020-08-18
Brief Summary
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This randomized phase II trial studies how well erlotinib hydrochloride (Tarceva) with or without bevacizumab (Avastin) works in treating patients with stage IV non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, may block tumor growth in different ways by targeting certain cells. Bevacizumab may also stop the growth of NSCLC by blocking the growth of new blood vessels necessary for tumor growth. It is not yet known whether erlotinib hydrochloride is more effective when given alone or with bevacizumab in treating patients with NSCLC.
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Detailed Description
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PRIMARY OBJECTIVE:
I. To determine the progression-free survival of erlotinib (erlotinib hydrochloride) and bevacizumab versus that of erlotinib alone for the purpose of deciding if the combination arm is worth pursuing in a phase III trial.
SECONDARY OBJECTIVES:
I. To investigate the overall survival of erlotinib and bevacizumab versus erlotinib alone.
II. To investigate the response rate of erlotinib and bevacizumab versus erlotinib alone.
III. To investigate the progression-free survival in patients with exon deletion 19 or exon 21 L858R point mutations.
IV. To investigate the toxicity of erlotinib and bevacizumab versus erlotinib alone using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
CORRELATIVE RESEARCH OBJECTIVES:
I. To correlate EGFR mutations detected in plasma deoxyribonucleic acid (DNA) with those detected in tumor DNA.
II. To estimate the prevalence of EGFR T790M resistance mutations from pretreatment tumor biopsies using more sensitive mutation detection methods.
III. To investigate progression free survival of EGFR mutant NSCLC patients with and without concurrent EGFR T790M detected from pre-treatment tumor specimen using allele specific quantitative polymerase chain reaction (PCR).
IV. To prospectively evaluate the predictive value of plasma VEGF-A levels on progression free survival in patients treated with erlotinib alone or in combination with bevacizumab.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM A: Patients receive erlotinib hydrochloride orally (PO) once daily (QD) on days 1-21. (erlotinib will no longer be supplied and all patients will be removed from study treatment. No further follow-up by any study participants as of September 1, 2019)
ARM B: Patients receive erlotinib hydrochloride as in Arm A and bevacizumab intravenously (IV) over 30-90 minutes on day 1. (erlotinib will no longer be supplied and all patients will be removed from study treatment. No further follow-up by any study participants as of September 1, 2019)
In both arms, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3-6 months for 6 years.
I. To determine the progression-free survival of erlotinib (erlotinib hydrochloride) and bevacizumab versus that of erlotinib alone for the purpose of deciding if the combination arm is worth pursuing in a phase III trial.
SECONDARY OBJECTIVES:
I. To investigate the overall survival of erlotinib and bevacizumab versus erlotinib alone.
II. To investigate the response rate of erlotinib and bevacizumab versus erlotinib alone.
III. To investigate the progression-free survival in patients with exon deletion 19 or exon 21 L858R point mutations.
IV. To investigate the toxicity of erlotinib and bevacizumab versus erlotinib alone using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
CORRELATIVE RESEARCH OBJECTIVES:
I. To correlate EGFR mutations detected in plasma deoxyribonucleic acid (DNA) with those detected in tumor DNA.
II. To estimate the prevalence of EGFR T790M resistance mutations from pretreatment tumor biopsies using more sensitive mutation detection methods.
III. To investigate progression free survival of EGFR mutant NSCLC patients with and without concurrent EGFR T790M detected from pre-treatment tumor specimen using allele specific quantitative polymerase chain reaction (PCR).
IV. To prospectively evaluate the predictive value of plasma VEGF-A levels on progression free survival in patients treated with erlotinib alone or in combination with bevacizumab.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM A: Patients receive erlotinib hydrochloride orally (PO) once daily (QD) on days 1-21. (erlotinib will no longer be supplied and all patients will be removed from study treatment. No further follow-up by any study participants as of September 1, 2019)
ARM B: Patients receive erlotinib hydrochloride as in Arm A and bevacizumab intravenously (IV) over 30-90 minutes on day 1. (erlotinib will no longer be supplied and all patients will be removed from study treatment. No further follow-up by any study participants as of September 1, 2019)
In both arms, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3-6 months for 6 years.
Conditions
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EGFR Exon 19 Deletion Mutation
EGFR NP_005219.2:p.L858R
Lung Non-Squamous Non-Small Cell Carcinoma
Stage IV Lung Non-Small Cell Cancer AJCC v7
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
SINGLE
Outcome Assessors
Study Groups
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Arm A (erlotinib hydrochloride)
Patients receive erlotinib hydrochloride PO QD on days 1-21. (erlotinib will no longer be supplied and all patients will be removed from study treatment. No further follow-up by any study participants as of September 1, 2019)
Group Type
ACTIVE_COMPARATOR
Erlotinib
Intervention Type
DRUG
Given PO
Erlotinib Hydrochloride
Intervention Type
DRUG
Given PO
Laboratory Biomarker Analysis
Intervention Type
OTHER
Correlative studies
Arm B (erlotinib hydrochloride, bevacizumab)
Patients receive erlotinib hydrochloride as in Arm A and bevacizumab IV over 30-90 minutes on day 1. (erlotinib will no longer be supplied and all patients will be removed from study treatment. No further follow-up by any study participants as of September 1, 2019)
Group Type
EXPERIMENTAL
Bevacizumab
Intervention Type
BIOLOGICAL
Given IV
Erlotinib
Intervention Type
DRUG
Given PO
Erlotinib Hydrochloride
Intervention Type
DRUG
Given PO
Laboratory Biomarker Analysis
Intervention Type
OTHER
Correlative studies
Interventions
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Bevacizumab
Given IV
Intervention Type
BIOLOGICAL
Erlotinib
Given PO
Intervention Type
DRUG
Erlotinib Hydrochloride
Given PO
Intervention Type
DRUG
Laboratory Biomarker Analysis
Correlative studies
Intervention Type
OTHER
Other Intervention Names
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Anti-VEGF
Anti-VEGF Humanized Monoclonal Antibody
Anti-VEGF rhuMAb
Avastin
Bevacizumab awwb
Bevacizumab Biosimilar BEVZ92
Bevacizumab Biosimilar BI 695502
Bevacizumab Biosimilar CBT 124
Bevacizumab Biosimilar CT-P16
Bevacizumab Biosimilar FKB238
Bevacizumab Biosimilar HD204
Bevacizumab Biosimilar HLX04
Bevacizumab Biosimilar IBI305
Bevacizumab Biosimilar LY01008
Bevacizumab Biosimilar MIL60
Bevacizumab Biosimilar QL 1101
Bevacizumab Biosimilar RPH-001
Bevacizumab Biosimilar SCT501
BP102
BP102 Biosimilar
HD204
Immunoglobulin G1 (Human-Mouse Monoclonal rhuMab-VEGF Gamma-Chain Anti-Human Vascular Endothelial Growth Factor), Disulfide With Human-Mouse Monoclonal rhuMab-VEGF Light Chain, Dimer
Recombinant Humanized Anti-VEGF Monoclonal Antibody
rhuMab-VEGF
SCT501
Cp-358,774
OSI-774
Tarceva
Eligibility Criteria
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Inclusion Criteria
* Histologic documentation of primary lung carcinoma, non-squamous histology with activating epidermal growth factor receptor (defined as deletion 19 or exon 21 L858R mutation); Note: EGFR mutation testing must be performed at a Clinical Laboratory Improvement Amendments (CLIA) certified lab; either institutional or through a commercial laboratory (e.g. Genzyme, Response Genetics, etc); the laboratory report from the commercial laboratories report the specific mutations detected, and the method of detecting the exon 19 and exon 21 L858R point mutations must be available
* Stage IV disease according to the 7th Edition of the American Joint Committee on Cancer staging system
* Measurable disease
* Life expectancy of \>= 12 months
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
* Absolute neutrophil count (ANC) \>= 1,500/mm\^3 obtained =\< 14 days prior to randomization
* Platelet count \>= 100,000/mm\^3 obtained =\< 14 days prior to randomization
* Hemoglobin \>= 9.0 g/dL obtained =\< 14 days prior to randomization
* Total bilirubin =\< 1.5 x upper limit of normal (ULN) obtained =\< 14 days prior to randomization
* Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) and serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) =\< 2.5 x ULN in patients without liver or bone metastases; \< 5 x ULN in patients with liver or bone metastases obtained =\< 14 days prior to randomization
* Cockcroft-Gault calculated creatinine clearance of \>= 45 ml/min or creatinine =\< 1.5 x ULN obtained =\< 14 days prior to randomization
* Urine dipstick proteinuria \< 2+ or urine protein/creatinine (UPC) ratio =\< 1.0 obtained =\< 14 days prior to randomization
* Note: patients discovered to have \>= 2 + proteinuria on dipstick urinalysis at baseline should undergo a 24-hour urine collection and must demonstrate =\< 1 g of protein in 24 hours
* Negative pregnancy test done =\< 7 days prior to randomization, for women of childbearing potential only
* Provide informed written consent
* Willing to return to Academic and Community Cancer Research United (ACCRU) enrolling institution for follow-up
* Willing to provide tissue and blood samples for correlative research purposes
* Stage IV disease according to the 7th Edition of the American Joint Committee on Cancer staging system
* Measurable disease
* Life expectancy of \>= 12 months
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
* Absolute neutrophil count (ANC) \>= 1,500/mm\^3 obtained =\< 14 days prior to randomization
* Platelet count \>= 100,000/mm\^3 obtained =\< 14 days prior to randomization
* Hemoglobin \>= 9.0 g/dL obtained =\< 14 days prior to randomization
* Total bilirubin =\< 1.5 x upper limit of normal (ULN) obtained =\< 14 days prior to randomization
* Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) and serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) =\< 2.5 x ULN in patients without liver or bone metastases; \< 5 x ULN in patients with liver or bone metastases obtained =\< 14 days prior to randomization
* Cockcroft-Gault calculated creatinine clearance of \>= 45 ml/min or creatinine =\< 1.5 x ULN obtained =\< 14 days prior to randomization
* Urine dipstick proteinuria \< 2+ or urine protein/creatinine (UPC) ratio =\< 1.0 obtained =\< 14 days prior to randomization
* Note: patients discovered to have \>= 2 + proteinuria on dipstick urinalysis at baseline should undergo a 24-hour urine collection and must demonstrate =\< 1 g of protein in 24 hours
* Negative pregnancy test done =\< 7 days prior to randomization, for women of childbearing potential only
* Provide informed written consent
* Willing to return to Academic and Community Cancer Research United (ACCRU) enrolling institution for follow-up
* Willing to provide tissue and blood samples for correlative research purposes
Exclusion Criteria
* Mixed, non-small cell and small cell tumors or mixed adenosquamous carcinomas with a predominant squamous component
* Prior chemotherapy or treatment for metastatic non-small cell lung cancer
* Any of the following:
* Pregnant women
* Nursing women
* Men or women of childbearing potential who are unwilling to employ adequate contraception
* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
* Immunocompromised patients (other than that related to the use of corticosteroids) including patients known to be human immunodeficiency virus (HIV) positive, per medical doctor (MD) discretion
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations, or any other medical condition that would limit compliance with study requirements
* Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
* Other active malignancy =\< 3 years prior to randomization; EXCEPTIONS: non melanotic skin cancer or carcinoma-in-situ of the cervix; Note: if there is a history of prior malignancy, they must not be receiving other specific treatment (i.e. hormonal therapy) for their cancer
* History of myocardial infarction or other evidence of arterial thrombotic disease (angina), symptomatic congestive heart failure (New York Heart Association \>= grade 2), unstable angina pectoris, or cardiac arrhythmia; Note: allowed only if patient has no evidence of active disease for at least 6 months prior to randomization
* History of cerebral vascular accident (CVA) or transient ischemic attack (TIA) =\< 6 months prior to randomization
* History of bleeding diathesis or coagulopathy
* Inadequately controlled hypertension (systolic blood pressure of \> 150 mmHg or diastolic pressure \> 100 mmHg on anti-hypertensive medications); Note: history of hypertensive crisis or hypertensive encephalopathy not allowed
* Current or recent (=\< 10 days prior to randomization) use of aspirin (\> 325 mg/day), clopidogrel (\> 75 mg/day), or prasugrel (\> 10 mg/day)
* Serious non-healing wound, ulcer, bone fracture, or have undergone a major surgical procedure, open biopsy, or significant traumatic injury =\< 28 days or core biopsy =\< 7 days prior to randomization
* History of abdominal fistula, gastrointestinal perforation, or intraabdominal abscess =\< 6 months prior to randomization
* Known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
* History of hemoptysis \>= grade 2 (defined as bright red blood of at least 2.5 mL) =\< 3 months prior to randomization
* Known central nervous system (CNS) disease, except for treated brain metastasis; Note: treatment for brain metastases may include whole brain radiotherapy (WBRT), radiosurgery (RS); gamma knife, linear accelerator (LINAC), or equivalent or a combination as deemed appropriate by the treating physician; patients with CNS metastases treated by neurosurgical resection or brain biopsy performed =\< 3 months prior to randomization will be excluded; Note: craniotomy or intracranial biopsy site must be adequately healed, free of drainage or cellulitis, and the underlying cranioplasty must appear intact at the time of randomization; study treatment should be initiated \> 28 days following the last surgical procedure (including biopsy, surgical resection, wound revision, or any other major surgery involving entry into a body cavity)
* Significant vascular disease (e.g. aortic aneurysm surgical repair or recent peripheral arterial thrombosis) =\< 6 months prior to randomization
* Radiotherapy to any site for any reason =\< 14 days prior to randomization
* Receiving any medications or substances that are strong or moderate inhibitors of CYP3A4; use of the following strong or moderate inhibitors are prohibited =\< 7 days prior to randomization:
* Strong inhibitors of CYP3A4: indinavir (Crixivan), nelfinavir (Viracept), atazanavir (Reyataz), ritonavir (Norvir), clarithromycin (Biaxin, Biaxin XL), itraconazole (Sporanox), ketoconazole (Nizoral), nefazodone (Serzone), saquinavir (Fortovase, Invirase), telithromycin (Ketek)
* Moderate inhibitors of CYP3A4: aprepitant (Emend), erythromycin (Erythrocin, E.E.S, Ery-Tab, Eryc, EryPed, PCE, fluconazole (Diflucan), grapefruit juice, verapamil (Calan, Calan SR, Covera-HS, Isoptin SR, Verelan, Verelan PM), diltiazem (Cardizem, Cardizem CD, Cardizem LA, Cardizem SR, Cartia XT, Dilacor XR, Diltia XT, Taztia XT, Tiazac)
* Receiving any medications or substances that are strong or moderate inducers of CYP3A4; use of the following inducers are prohibited =\< 7 days prior to randomization: efavirenz (Sustiva), nevirapine (Viramune), carbamazepine (Carbatrol, Epitol, Equetro, Tegretol, Tegretol-XR), modafinil (Provigil), phenobarbital (Luminal), phenytoin (Dilantin, Phenytek), pioglitazone (Actos), rifabutin (Mycobutin), rifampin (Rifadin), St. John?s wort
* Prior chemotherapy or treatment for metastatic non-small cell lung cancer
* Any of the following:
* Pregnant women
* Nursing women
* Men or women of childbearing potential who are unwilling to employ adequate contraception
* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
* Immunocompromised patients (other than that related to the use of corticosteroids) including patients known to be human immunodeficiency virus (HIV) positive, per medical doctor (MD) discretion
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations, or any other medical condition that would limit compliance with study requirements
* Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
* Other active malignancy =\< 3 years prior to randomization; EXCEPTIONS: non melanotic skin cancer or carcinoma-in-situ of the cervix; Note: if there is a history of prior malignancy, they must not be receiving other specific treatment (i.e. hormonal therapy) for their cancer
* History of myocardial infarction or other evidence of arterial thrombotic disease (angina), symptomatic congestive heart failure (New York Heart Association \>= grade 2), unstable angina pectoris, or cardiac arrhythmia; Note: allowed only if patient has no evidence of active disease for at least 6 months prior to randomization
* History of cerebral vascular accident (CVA) or transient ischemic attack (TIA) =\< 6 months prior to randomization
* History of bleeding diathesis or coagulopathy
* Inadequately controlled hypertension (systolic blood pressure of \> 150 mmHg or diastolic pressure \> 100 mmHg on anti-hypertensive medications); Note: history of hypertensive crisis or hypertensive encephalopathy not allowed
* Current or recent (=\< 10 days prior to randomization) use of aspirin (\> 325 mg/day), clopidogrel (\> 75 mg/day), or prasugrel (\> 10 mg/day)
* Serious non-healing wound, ulcer, bone fracture, or have undergone a major surgical procedure, open biopsy, or significant traumatic injury =\< 28 days or core biopsy =\< 7 days prior to randomization
* History of abdominal fistula, gastrointestinal perforation, or intraabdominal abscess =\< 6 months prior to randomization
* Known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
* History of hemoptysis \>= grade 2 (defined as bright red blood of at least 2.5 mL) =\< 3 months prior to randomization
* Known central nervous system (CNS) disease, except for treated brain metastasis; Note: treatment for brain metastases may include whole brain radiotherapy (WBRT), radiosurgery (RS); gamma knife, linear accelerator (LINAC), or equivalent or a combination as deemed appropriate by the treating physician; patients with CNS metastases treated by neurosurgical resection or brain biopsy performed =\< 3 months prior to randomization will be excluded; Note: craniotomy or intracranial biopsy site must be adequately healed, free of drainage or cellulitis, and the underlying cranioplasty must appear intact at the time of randomization; study treatment should be initiated \> 28 days following the last surgical procedure (including biopsy, surgical resection, wound revision, or any other major surgery involving entry into a body cavity)
* Significant vascular disease (e.g. aortic aneurysm surgical repair or recent peripheral arterial thrombosis) =\< 6 months prior to randomization
* Radiotherapy to any site for any reason =\< 14 days prior to randomization
* Receiving any medications or substances that are strong or moderate inhibitors of CYP3A4; use of the following strong or moderate inhibitors are prohibited =\< 7 days prior to randomization:
* Strong inhibitors of CYP3A4: indinavir (Crixivan), nelfinavir (Viracept), atazanavir (Reyataz), ritonavir (Norvir), clarithromycin (Biaxin, Biaxin XL), itraconazole (Sporanox), ketoconazole (Nizoral), nefazodone (Serzone), saquinavir (Fortovase, Invirase), telithromycin (Ketek)
* Moderate inhibitors of CYP3A4: aprepitant (Emend), erythromycin (Erythrocin, E.E.S, Ery-Tab, Eryc, EryPed, PCE, fluconazole (Diflucan), grapefruit juice, verapamil (Calan, Calan SR, Covera-HS, Isoptin SR, Verelan, Verelan PM), diltiazem (Cardizem, Cardizem CD, Cardizem LA, Cardizem SR, Cartia XT, Dilacor XR, Diltia XT, Taztia XT, Tiazac)
* Receiving any medications or substances that are strong or moderate inducers of CYP3A4; use of the following inducers are prohibited =\< 7 days prior to randomization: efavirenz (Sustiva), nevirapine (Viramune), carbamazepine (Carbatrol, Epitol, Equetro, Tegretol, Tegretol-XR), modafinil (Provigil), phenobarbital (Luminal), phenytoin (Dilantin, Phenytek), pioglitazone (Actos), rifabutin (Mycobutin), rifampin (Rifadin), St. John?s wort
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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National Cancer Institute (NCI)
NIH
Sponsor Role
collaborator
Academic and Community Cancer Research United
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Thomas E Stinchcombe
Role: PRINCIPAL_INVESTIGATOR
Academic and Community Cancer Research United
Locations
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UC San Diego Moores Cancer Center
La Jolla, California, United States
Site Status
Heartland Cancer Research NCORP
Decatur, Illinois, United States
Site Status
Illinois CancerCare-Peoria
Peoria, Illinois, United States
Site Status
Carle Cancer Center NCI Community Oncology Research Program
Urbana, Illinois, United States
Site Status
Michigan Cancer Research Consortium NCORP
Ann Arbor, Michigan, United States
Site Status
Cancer Research Consortium of West Michigan NCORP
Grand Rapids, Michigan, United States
Site Status
Mayo Clinic
Rochester, Minnesota, United States
Site Status
Coborn Cancer Center at Saint Cloud Hospital
Saint Cloud, Minnesota, United States
Site Status
Washington University School of Medicine
St Louis, Missouri, United States
Site Status
New Hampshire Oncology Hematology PA-Hooksett
Hooksett, New Hampshire, United States
Site Status
Hematology Oncology Associates of Central New York-East Syracuse
East Syracuse, New York, United States
Site Status
State University of New York Upstate Medical University
Syracuse, New York, United States
Site Status
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
Site Status
Duke University Medical Center
Durham, North Carolina, United States
Site Status
Sanford Broadway Medical Center
Fargo, North Dakota, United States
Site Status
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Site Status
Upstate Carolina CCOP
Spartanburg, South Carolina, United States
Site Status
Rapid City Regional Hospital
Rapid City, South Dakota, United States
Site Status
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, United States
Site Status
Countries
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United States
References
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Stinchcombe TE, Janne PA, Wang X, Bertino EM, Weiss J, Bazhenova L, Gu L, Lau C, Paweletz C, Jaslowski A, Gerstner GJ, Baggstrom MQ, Graziano S, Bearden J 3rd, Vokes EE. Effect of Erlotinib Plus Bevacizumab vs Erlotinib Alone on Progression-Free Survival in Patients With Advanced EGFR-Mutant Non-Small Cell Lung Cancer: A Phase 2 Randomized Clinical Trial. JAMA Oncol. 2019 Oct 1;5(10):1448-1455. doi: 10.1001/jamaoncol.2019.1847.
Reference Type
DERIVED
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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NCI-2012-00053
Identifier Type: REGISTRY
Identifier Source: secondary_id
11-006881
Identifier Type: -
Identifier Source: secondary_id
RC1126
Identifier Type: OTHER
Identifier Source: secondary_id
RC1126
Identifier Type: -
Identifier Source: org_study_id
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PHASE2
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PHASE2
Combination Chemotherapy, Bev, RT, and Erlotinib in Treating Patients With Stage III Non-Small Cell Lung Cancer
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PHASE1/PHASE2
Erlotinib in Treating Patients With Advanced Non-Small Cell Lung Cancer
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PHASE2
Erlotinib and Cetuximab in Treating Patients With Advanced Solid Tumors With Emphasis on Non-Small Cell Lung Cancer
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COMPLETED
PHASE1/PHASE2