A Phase 2 Trial of Adagrasib Monotherapy and in Combination with Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination with Pembrolizumab versus Pembrolizumab in Patients with Advanced Non Small Cell Lung Cancer with KRAS G12C Mutation

Conditions

Advanced Non-Small Cell Lung Cancer

Brief summary

Phase 2: Obejective Response Rate (ORR) as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by Investigator, Phase 3: Dual primary endpoints: 1. PFS (RECIST 1.1) by BICR 2. OS

Detailed description

Phase 2: 1. Safety characterized by type, incidence, severity, timing, seriousness and relationship to study treatment of adverse events and laboratory abnormalities, Phase 2: 2. Duration of Response (DOR), Progression - Free Survival (PFS), 1-Year Survival rate, Overall Survival (OS), Phase 2: 3. Pharmacokinetics (PK) Blood plasma adagrasib and potential metabolite concentrations, Phase 3: 1. PFS (RECIST v1.1) by Investigator - OR (RECIST v1.1) by Investigator and BICR - DOR (RECIST v1.1) by Investigator and BICR1, Phase 3: 2. Safety characterized by type, incidence, severity, timing, seriousness and relationship to study treatment of AEs, laboratory abnormalities, and number of patients discontinuing study treatment due to an AE, Phase 3: 3. Population PK parameters of adagrasib, Phase 3: 4. Patient-reported outcome (PRO) to measure quality of life

Related papers

No related papers found yet.

Interventions

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

DRUGAdagrasib

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Phase 2: Obejective Response Rate (ORR) as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by Investigator, Phase 3: Dual primary endpoints: 1. PFS (RECIST 1.1) by BICR 2. OS	—

Secondary

Measure	Time frame
Phase 2: 1. Safety characterized by type, incidence, severity, timing, seriousness and relationship to study treatment of adverse events and laboratory abnormalities, Phase 2: 2. Duration of Response (DOR), Progression - Free Survival (PFS), 1-Year Survival rate, Overall Survival (OS), Phase 2: 3. Pharmacokinetics (PK) Blood plasma adagrasib and potential metabolite concentrations, Phase 3: 1. PFS (RECIST v1.1) by Investigator - OR (RECIST v1.1) by Investigator and BICR - DOR (RECIST v1.1) by Investigator and BICR1, Phase 3: 2. Safety characterized by type, incidence, severity, timing, seriousness and relationship to study treatment of AEs, laboratory abnormalities, and number of patients discontinuing study treatment due to an AE, Phase 3: 3. Population PK parameters of adagrasib, Phase 3: 4. Patient-reported outcome (PRO) to measure quality of life	—

Measure

Time frame

Phase 2: 1. Safety characterized by type, incidence, severity, timing, seriousness and relationship to study treatment of adverse events and laboratory abnormalities, Phase 2: 2. Duration of Response (DOR), Progression - Free Survival (PFS), 1-Year Survival rate, Overall Survival (OS), Phase 2: 3. Pharmacokinetics (PK) Blood plasma adagrasib and potential metabolite concentrations, Phase 3: 1. PFS (RECIST v1.1) by Investigator - OR (RECIST v1.1) by Investigator and BICR - DOR (RECIST v1.1) by Investigator and BICR1, Phase 3: 2. Safety characterized by type, incidence, severity, timing, seriousness and relationship to study treatment of AEs, laboratory abnormalities, and number of patients discontinuing study treatment due to an AE, Phase 3: 3. Population PK parameters of adagrasib, Phase 3: 4. Patient-reported outcome (PRO) to measure quality of life

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Countries

Austria, Belgium, Bulgaria, Croatia, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Netherlands, Norway, Poland, Portugal, Romania, Spain

Outcome results

None listed