A Phase 2 Randomized Open-label Study of Erlotinib Plus Tivantinib (ARQ 197) Versus Single Agent Chemotherapy in Previously Treated KRAS Mutation Positive Subjects With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
The purpose of this study is to evaluate progression-free survival among subjects with KRAS mutation positive Non-Small Cell Lung Cancer (NSCLC) treated with erlotinib plus tivantinib (ARQ 197) compared to single agent chemotherapy.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : Pemetrexed, docetaxel or gemcitabine
- drug : ARQ 197 plus erlotinib
Phase: Phase 2
Ages Eligible For Study:
1. Provide signed and dated informed consent prior to study-specific screening procedures 2. Male or female at least 18 years of age 3. Histologically or cytologically confirmed inoperable locally advanced or metastatic (stage IVA/IVB) NSCLC 4. Documented KRAS mutation positive status (per LCMC guidelines; see www.golcmc.com) 5. At least one prior chemotherapy regimen for advanced NSCLC 6. Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria, Version 1.1 7. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 8. Male or female subjects of child-producing potential must agree to use double barrier contraception, oral contraceptives or avoidance of pregnancy measures during the study and for 90 days after the last day of treatment 9. Females of childbearing potential must have a negative serum pregnancy test 10. Aspartate transaminase (AST) and alanine transaminase (ALT) ? 2.5 × upper limit of normal (ULN) or ? 5 × ULN with metastatic liver disease 11. Total bilirubin ? 1.5 × ULN 12. Serum creatinine ? 1.5 × ULN 13. Absolute neutrophil count (ANC) ? 1.5 x 10^9/L 14. Platelets ? 100 x 10^9/L 15. Hemoglobin ? 10 g/dL (transfusion is allowed at least 7 days prior to randomization) 16. Subjects must agree to allow testing for c-Met status if archival and/or fresh tissue biopsy samples are available.