Combination Therapies With Adagrasib in Patients With Advanced NSCLC With KRAS G12C Mutation

Conditions

• Advanced NSCLC
• Metastatic Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Adagrasib oral dose of 400 mg twice daily tablets — DRUG
  oral dose of 400 mg twice daily tablets
• Pembrolizumab — COMBINATION_PRODUCT
  IV infusion once every 3 weeks
• Chemotherapy: Pemetrexed — COMBINATION_PRODUCT
  IV infusion once every 3 weeks
• Cisplatin/Carboplatin — COMBINATION_PRODUCT
  IV infusion once every 3 weeks

Study Details

Study CA239-0010 is an open-label, Phase 2 clinical trial evaluating the clinical efficacy of adagrasib in combination with pembrolizumab and chemotherapy in the first-line setting for patients with advanced NSCLC with TPS ≥ 1%, TPS \<50% and KRAS G12C mutation

Key Dates

Start date

Nov 22, 2022

Status verified

Aug 2025

Primary completion

Jun 1, 2026

Completion

Dec 1, 2026

Study Design

Enrollment

90 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Cohort A: PD-L1 TPS≥ 1% (Closed)
  Adagrasib 400 mg BID for 2 cycles followed by adagrasib 400 mg BID + pembrolizumab 200 mg every 3 weeks (Q3W) up to 35 cycles
• Experimental: Cohort C
  Adagrasib 400 mg BID + pemetrexed 500 mg/m2 Q3W + pembrolizumab 200 mg Q3W up to 31 cycles
• Experimental: Cohort E
  Adagrasib 400 mg BID + pembrolizumab 200 mg Q3W + pemetrexed 500 mg/m2 + cisplatin 75 mg/m2 Q3W OR carboplatin AUC 5 Q3W for 4 cycles, followed by adagrasib 400 mg BID + pemetrexed 500 mg/m2 Q3W + pembrolizumab 200 mg Q3W (up to 31 cycles)

Primary Outcome Measure

Objective Response Rate (ORR) for Cohort A and E [ Time Frame: 30 months ]

Central Contacts

• BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
  855-907-3286
  [email protected]
• First line of the email MUST contain the NCT# and Site #.

Locations (84)

Find similar trials in Anchorage, AK

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