Randomized Proteomic Stratified Phase III Study of Second-Line Erlotinib Versus Chemotherapy in Patients With Inoperable Non Small Cell Lung Cancer
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- Enrollment
- 275
- Locations
- 2
- Primary Endpoint
- Overall survival
Study Overview
Brief Summary
RATIONALE: Studying the proteins expressed in samples of blood and tissue from patients with cancer may help doctors identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.
PURPOSE: This randomized phase III trial is studying blood and tissue samples in predicting response to second-line therapy using erlotinib hydrochloride or chemotherapy in patients with advanced non-small cell lung cancer.
Detailed Description
OBJECTIVES:
- To evaluate the predictive value of proteomic profiling on the effect of second-line therapy with erlotinib hydrochloride vs standard chemotherapy (pemetrexed disodium or docetaxel) in patients with advanced non-small cell lung cancer.
- To assess the role of other known tissue-based predictive markers (e.g., EGFR-gene copy number, EGFR-protein expression, pAkt, pMAPK, EGFR mutations, EMT markers, and k-Ras mutation).
OUTLINE: This is a multicenter study. Patients are stratified according to smoking status, performance status, proteomic profile, and participating center. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive standard chemotherapy with pemetrexed disodium, docetaxel, or another standard drug.
- Arm II: Patients receive standard non-chemotherapy treatment with erlotinib hydrochloride.
Serum is collected after failure of first-line therapy for proteomic analysis by matrix-associated laser desorption/ionization-time of flight. Tissue and blood samples are collected periodically for analysis including EGFR based on IHC and FISH, EGFR and k-Ras mutations, pAkt, pMAPK by IHC, and EMT markers based on IHC and breath condensate protein profile.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC)
- •Advanced NSCLC (stage IIIB or IV)
- •Measurable disease
- •Underwent previous treatment with 1 non-tyrosine kinase inhibitor as first-line therapy for advanced NSCLC
- •No clinical evidence of uncontrolled brain metastases
- •PATIENT CHARACTERISTICS:
- •Caucasian
- •ECOG performance status 0-2
- •Absolute granulocyte count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Bilirubin ≤ 1.5 times upper limit of normal (ULN) (≤ 2.5 times ULN in patients with known liver metastases)
- •ALT or AST ≤ 3 times ULN (≤ 5 times ULN in patients with known liver metastases)
- •Creatinine clearance ≥ 50 mL/min
- •Not pregnant or nursing
- •Able to comply with planned study procedures
- •No multiple severe diseases that can compromise safety (cardiac and renal failure, peripheral neuropathy)
- •No other malignancy (except for basal cell skin carcinoma) or pre-neoplastic condition requiring chemotherapeutic treatment
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •At least 3 weeks since prior surgery or radiotherapy
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Overall survival
Secondary Outcomes
- Progression-free survival
- Overall response rate according to RECIST criteria