An Open-label, Uncontrolled Study of ONO-4578 and ONO-4538 in Combination With Standard-of-care Docetaxel and Ramucirumab as Second-line Therapy in Patients With Advanced or Recurrent Non-small Cell Lung Cancer
Phase 1 Study of ONO-4578 Given as Combinations of ONO-4578, ONO-4538, Docetaxel and Ramucirumab in Subjects With Metastatic Non-small Cell Lung Cancer Who Have Had Disease Progression During or After One Prior First-line Anti-PD-(L) 1 Antibody and Platinum-based Chemotherapy for Advanced/Metastatic Disease
Sponsor: Ono Pharmaceutical Co., Ltd.
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Dose-limiting toxicities（DLT）
Time frame: 21 days
Adverse event(AE)
Time frame: Up to 28 days after the last dose
Secondary Endpoints
Pharmacokinetics（Plasma concentration of ONO-4578）
Pharmacokinetics（serum concentration of ONO-4538）
Overall response rate (ORR)
Eligibility Criteria
Inclusion Criteria: 1. Clinical stage III B/ III C with unsuitable for radical irradiation, Clinical stage IV or recurrent non-small cell lung cancer 2. Life expectancy of at least 3 months 3. Patients with ECOG performance status 0 or 1 Exclusion Criteria: 1. Patients with severe complication 2. Patients with multiple primary cancers
✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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