Phase 2 Active, not recruiting NCT04330664

Adagrasib + pembrolizumab in KRAS G12C-mutated non-small cell lung cancer

Mirati Therapeutics (a Bristol-Myers Squibb company) · Interventional, Non-randomized · n=140

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Medicine Lung Cancer

Overview

Adagrasib is a KRAS G12C inhibitor; pembrolizumab is a PD-1 checkpoint inhibitor. This Phase 2 study combines them in first-line treatment of locally advanced or metastatic NSCLC with KRAS G12C mutation, evaluating whether the combination produces durable responses beyond what either agent achieves alone.

Full record on ClinicalTrials.gov (NCT ID NCT04330664).

Recruitment criteria

Inclusion criteria

- Age ≥ 18 years - Confirmed KRAS G12C mutation by central testing - Locally advanced or metastatic NSCLC - ECOG performance status 0 or 1 - No prior systemic therapy for advanced disease

Exclusion criteria

- Active brain metastases (treated and stable allowed) - Active autoimmune disease requiring systemic immunosuppression - Prior anti-PD-1 / anti-PD-L1 therapy

Age range: ≥ 18 · Sex: All · Healthy volunteers: Requires diagnosis

Study design

Phase: Phase 2
Study type: Interventional
Allocation: Non-randomized
Masking: Open label
Intervention model: Single group assignment
Primary purpose: Treatment
Enrollment target: 140 participants
Started: June 2023
Estimated completion: December 2027

Outcome measures

Primary endpoint

Objective response rate (ORR) at 12 months

Secondary endpoints

- Progression-free survival - Overall survival at 24 months - Duration of response - Treatment-emergent adverse events grade ≥ 3

Locations & contacts

Showing 4 of 4 sites

4 sites currently enrolling. Representative sites shown below; full site list on ClinicalTrials.gov.

Memorial Sloan Kettering — New York, NY

Principal Investigator: Charles M. Rudin, MD · Status: Active

Dana-Farber Cancer Institute — Boston, MA

Principal Investigator: Pasi A. Jänne, MD · Status: Active

MD Anderson Cancer Center — Houston, TX

Principal Investigator: John V. Heymach, MD · Status: Active

Royal Marsden NHS Trust — London (UK)

Principal Investigator: Sanjay Popat, MD · Status: Active

Sources

REG

ClinicalTrials.gov — NCT04330664

Trial registry · primary record