Untreated advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) without/with a STK11 mutation.
Conditions
Brief summary
Phase 1b: The incidence of dose limiting toxicities (DLTs) during a 21-day assessment period in treatment cycle 1 (i.e., the first 21 days from cycle 1 day 1 (C1D1) for each subject) Phase 2a: Objective response rate (ORR - complete response and partial response per RECIST 1.1) at 6 and 12 months.
Detailed description
Phase 1b: - ORR (complete response and partial response per RECIST 1.1) Phase 2a: - The frequency and percentage of AEs; assessment of safety laboratory parameters, vital signs, and ECGs per CTCAE, Phase 1b: - Disease control rate (DCR) (complete response, partial response, and stable disease per RECIST 1.1) Phase 2a: - DCR (complete response, partial response, and stable disease), Phase 1b: - Duration of response (DOR) Time of first response to progressive disease as assessed per RECIST 1.1) Phase 2a: - DOR, Phase 1b: - Overall survival Phase 2a: - Progression free survival (PFS), Phase 2a: - Time to progression (TTP), Phase 2a: - Overall survival, Phase 2a: - PK exposure (Cmax, AUC, and t½)
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase 1b: The incidence of dose limiting toxicities (DLTs) during a 21-day assessment period in treatment cycle 1 (i.e., the first 21 days from cycle 1 day 1 (C1D1) for each subject) Phase 2a: Objective response rate (ORR - complete response and partial response per RECIST 1.1) at 6 and 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase 1b: - ORR (complete response and partial response per RECIST 1.1) Phase 2a: - The frequency and percentage of AEs; assessment of safety laboratory parameters, vital signs, and ECGs per CTCAE, Phase 1b: - Disease control rate (DCR) (complete response, partial response, and stable disease per RECIST 1.1) Phase 2a: - DCR (complete response, partial response, and stable disease), Phase 1b: - Duration of response (DOR) Time of first response to progressive disease as assessed per RECIST 1.1) Phase 2a: - DOR, Phase 1b: - Overall survival Phase 2a: - Progression free survival (PFS), Phase 2a: - Time to progression (TTP), Phase 2a: - Overall survival, Phase 2a: - PK exposure (Cmax, AUC, and t½) | — |
Countries
France, Greece, Hungary, Italy, Poland, Spain