Non-small-cell Lung Cancer
Conditions
Brief summary
The primary objective of this study is to determine if the combination regimen of ARQ 197 with erlotinib will improve overall survival (OS) compared to erlotinib monotherapy in subjects with locally advanced or metastatic non-squamous NSCLC with wild-type EGFR who have received 1 or 2 prior systemic anti-cancer therapies in the Intent-to-Treat (ITT) population.
Interventions
DRUGPlacebo and Erlotinib
Oral twice daily administration of placebo and oral once daily administration of erlotinib
Oral twice daily administration of ARQ197 and oral once daily administration of erlotinib
Sponsors
Kyowa Kirin Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female at least 20 years of age with life expectancy ≥ 3 months 2. Histologically or cytologically confirmed surgically unresectable locally advanced or metastatic (stage IIIB/IV) non-squamous NSCLC with wild-type (excluding major activating mutation (exon 19 deletion and/or exon 21 L858R mutation)) EGFR gene status confirmed by a highly sensitive PCR assay 3. Evaluable disease according to RECIST, Version 1.1 4. Received one or two prior lines of systemic anti-cancer therapy for advanced or metastatic disease, one of which must be a platinum-based therapy 5. ECOG performance status of 0 or 1 6. Demonstrate adequate bone marrow, liver, and renal functions, defined as: • ALT and AST ≤ 2.5 × upper limit of normal (ULN), total bilirubin ≤ 1.5 × ULN, ANC ≥1.5 × 10\^9/L, platelet count ≥100 × 10\^9/L, hemoglobin ≥9.0 g/dL, and serum creatinine ≤1.5 mg/dL. 7. Voluntary written informed consent form before performance of any study-specific procedures or tests
Exclusion criteria
1. Prior therapy with an EGFR inhibitor and/or tivantinib 2. Any systemic anti-tumor treatment for NSCLC or investigational agents within 4 weeks prior to randomization 3. Palliative radiotherapy within 2 weeks, or radiotherapy for curative intent of target lesions within 8 weeks for chest and within 4 weeks for other areas prior to randomization 4. Major surgical procedure within 4 weeks prior to randomization 5. History of cardiac disease 6. Known symptomatic brain metastases 7. Need to breastfeed a child during or within 12 weeks of completing the study 8. Significant gastrointestinal disorder that could interfere with absorption of tivantinib and/or erlotinib 9. History of malignancy other than NSCLC 10. Known infection with HIV, active HBV or HCV 11. Clinically significant interstitial lung diseases detected by CT scan or prior history of such diseases 12. Psychiatric disease that could affect the informed consent process 13. Subjects who wish to have a child and who would not agree to use one or more contraceptive measures that are highly effective 14. Positive serum or urine pregnancy test in female subjects of childbearing potential 15. Any other significant co-morbid condition that, in opinion of the investigator/sub-investigator, would impair study participation or cooperation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival | — | — |
| Objective response rate | — | Each assessment will be determined based on RECIST criteria version 1.1 by investigator |
| Number of patients with adverse events | — | — |
Countries
Japan
Outcome results
None listed