A Phase 1/2 Study of Avutometinib (VS-6766) in Combination with Sotorasib in Patients with KRAS G12C mutant Non-Small Cell Lung Cancer (NSCLC) (RAMP 203)

Conditions

Non-small cell lung cancer

Brief summary

Part A Dose Evaluation: Dose-limiting toxicities (DLTs), adverse events (AEs), serious AEs (s), physical examinations, clinical laboratory values, and tolerability (dose interruptions/reductions). -Part B Dose Expansion: Confirmed ORR (partial response [PR] + complete response [CR] defined according to Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST 1.1])

Detailed description

Adverse events, SAEs, physical examinations, clinical laboratory values, and tolerability (dose interruptions/reductions)., Duration of response (DOR), Disease control rate (DCR), defined as Complete response (CR) + Partial response (PR) + Stable disease (SD), Clinical benefit rate (CBR), defined as complete response (CR) + partial response (PR) + stable disease (SD) ≥ 6 months, Progression-free survival (PFS) defined as the time from first dose of study treatment to the first documentation of progressive disease (PD), or death from any cause, Overall survival (OS), PK parameters derived from plasma concentrations of avutometinib, sotorasib, defactinib, and relevant metabolites

Related papers

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Interventions

DRUGLUMYKRAS 120 mg film-coated tablets

DRUGVS-6063

DRUGVS-6766

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Part A Dose Evaluation: Dose-limiting toxicities (DLTs), adverse events (AEs), serious AEs (s), physical examinations, clinical laboratory values, and tolerability (dose interruptions/reductions). -Part B Dose Expansion: Confirmed ORR (partial response [PR] + complete response [CR] defined according to Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST 1.1])	—

Secondary

Measure	Time frame
Adverse events, SAEs, physical examinations, clinical laboratory values, and tolerability (dose interruptions/reductions)., Duration of response (DOR), Disease control rate (DCR), defined as Complete response (CR) + Partial response (PR) + Stable disease (SD), Clinical benefit rate (CBR), defined as complete response (CR) + partial response (PR) + stable disease (SD) ≥ 6 months, Progression-free survival (PFS) defined as the time from first dose of study treatment to the first documentation of progressive disease (PD), or death from any cause, Overall survival (OS), PK parameters derived from plasma concentrations of avutometinib, sotorasib, defactinib, and relevant metabolites	—

Measure

Time frame

Adverse events, SAEs, physical examinations, clinical laboratory values, and tolerability (dose interruptions/reductions)., Duration of response (DOR), Disease control rate (DCR), defined as Complete response (CR) + Partial response (PR) + Stable disease (SD), Clinical benefit rate (CBR), defined as complete response (CR) + partial response (PR) + stable disease (SD) ≥ 6 months, Progression-free survival (PFS) defined as the time from first dose of study treatment to the first documentation of progressive disease (PD), or death from any cause, Overall survival (OS), PK parameters derived from plasma concentrations of avutometinib, sotorasib, defactinib, and relevant metabolites

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Countries

Belgium, France, Netherlands, Spain

Outcome results

None listed