Status:
TERMINATED
Erlotinib Hydrochloride or Crizotinib and Chemoradiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Collaborating Sponsors:
NRG Oncology
Conditions:
Stage III Non-Small Cell Lung Cancer AJCC v7
Stage IIIA Non-Small Cell Lung Cancer AJCC v7
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This randomized phase II trial studies how well erlotinib hydrochloride or crizotinib with chemoradiation therapy works in treating patients with stage III non-small cell lung cancer. Radiation therap...
Detailed Description
PRIMARY OBJECTIVES: I. To assess whether patients with unresectable local-regionally advanced non-small cell lung cancer (NSCLC) treated with targeted agents based on molecular characteristics have a...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed, newly diagnosed non-squamous NSCLC
- Unresectable stage IIIA or IIIB disease; patients must be surgically staged to confirm N2 or N3 disease; patients may have invasive mediastinal staging by mediastinoscopy, mediastinotomy, endobronchial ultrasound transbronchial aspiration (EBUS-TBNA), endoscopic ultrasound (EUS), or video-assisted thoracoscopic surgery (VATS)
- Patients with any tumor (T) with node (N)2 or N3 are eligible; patients with T3, N1-N3 disease are eligible if deemed unresectable; patients with T4, any N are eligible
- Patients must have measurable disease, i.e., lesions that can be accurately measured in at least 1 dimension (longest dimension in the plane of measurement is to be recorded) with a minimum size of 10 mm by computed tomography (CT) scan (CT scan slice thickness no greater than 5 mm)
- Patients with a pleural effusion, which is a transudate, cytologically negative and non-bloody, are eligible if the radiation oncologist feels the tumor can be encompassed within a reasonable field of radiotherapy
- If a pleural effusion can be seen on the chest CT but not on chest x-ray and is too small to tap, the patient will be eligible; patients who develop a new pleural effusion after thoracotomy or other invasive thoracic procedure will be eligible
- The institution's pre-enrollment biomarker screening at a Clinical Laboratory Improvement Amendments (CLIA) certified lab documents presence of known "sensitive" mutations in epidermal growth factor receptor tyrosine kinase (EGFR TK) domain (exon 19 deletion, L858) and/or EML4-anaplastic lymphoma kinase (ALK) fusion arrangement; either the primary tumor or the metastatic lymph node tissue may be used for testing of mutations
- The institution's pre-enrollment biomarker screening at a CLIA certified lab documents absence of T790M mutation in the EGFR TK domain
- Appropriate stage for protocol entry, including no distant metastases, based upon the following minimum diagnostic workup:
- History/physical examination, including recording of pulse, blood pressure (BP), weight, and body surface area, within 45 days prior to registration
- Whole body fludeoxyglucose-positron emission tomography (FDG-PET)/CT (orbits to mid-thighs) within 30 days prior to registration; PET/CT must be negative for distant metastasis
- CT scan with contrast of the chest and upper abdomen to include liver and adrenals (unless medically contraindicated) within 30 days prior to registration
- Magnetic resonance imaging (MRI) of the brain with contrast (or CT scan with contrast, if MRI medically contraindicated) within 30 days prior to registration
- Zubrod performance status 0-1 within 14 days prior to registration
- Absolute neutrophil count (ANC) \>= 1,000 cells/mm\^3
- Platelets \>= 100,000 cells/mm\^3
- Hemoglobin \>= 8.0 g/dl (Note: the use of transfusion or other intervention to achieve hemoglobin \[Hgb\] \>= 8.0 g/dl is acceptable)
- Serum creatinine \< 1.5 mg/dL or calculated creatinine clearance \>= 50 ml/min (by Cockcroft-Gault formula) within 14 days prior to registration
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 2.5 x upper limit of normal (ULN) within 14 days prior to registration
- Bilirubin within normal institutional limits within 14 days prior to registration
- Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential
- Patient must provide study specific informed consent prior to study entry, including consent for mandatory screening of tissue
Exclusion
- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 730 days (2 years) (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible)
- Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable
- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
- Atelectasis of the entire lung
- Contralateral hilar node involvement
- Exudative, bloody, or cytologically malignant effusions
- Severe, active co-morbidity, defined as follows:
- Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
- Transmural myocardial infarction within the last 6 months
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
- Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration; hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
- Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol; protocol-specific requirements may also exclude immuno-compromised patients
- Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
- Prior allergic reaction to the study drug(s) involved in this protocol
Key Trial Info
Start Date :
November 4 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 4 2018
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT01822496
Start Date
November 4 2013
End Date
June 4 2018
Last Update
August 5 2019
Active Locations (174)
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1
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States, 35233
2
Providence Alaska Medical Center
Anchorage, Alaska, United States, 99508
3
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
4
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259