Phase 2 Study of Adagrasib Monotherapy and in Combination With Pembrolizumab and Phase 3 Study of Adagrasib in Combination with Pembrolizumab versus Pembrolizumab in Patients with Advanced Non-Small Cell Lung Cancer with KRAS G12C Mutatio

Phase 1

• Conditions: Advanced Non-Small Cell Lung Cancer; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]; MedDRA version: 21.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2020-003101-58-BG
• Lead Sponsor: Mirati Therapeutics, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-03
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 806

Inclusion Criteria

Phase 2: Histologically confirmed diagnosis of unresectable or metastatic NSCLC with KRAS G12C mutation and any PD-L1 TPS

Phase 3: Histologically confirmed diagnosis of unresectable or metastatic NSCLC (squamous or nonsquamous) with KRAS G12C mutation and PD-L1 TPS = 50% confirmed (qualifying results using Qiagen therascreen KRAS RGQ PCR kit and PharmDx 22C3 must be obtained either locally or centrally).

Phase 3: Presence of evaluable or measurable disease per RECIST version 1.1.

Phase 3: CNS Inclusion–- Based on screening brain imaging, patients must have one of the following:
1. No evidence of brain metastases
2. Untreated brain metastases not needing immediate local therapy
3. Previously treated brain metastases not needing immediate local therapy
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 403
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 403

Exclusion Criteria

Phase 2 and Phase 3: Prior systemic treatment for locally advanced or metastatic NSCLC including chemotherapy, immune checkpoint inhibitor therapy, or a therapy targeting KRAS G12C mutation (e.g., sotorasib)

Phase 2 and Phase 3: Radiation to the lung > 30 Gy within 6 months prior to the first dose of study treatment.

Phase 2: Active brain metastases

Phase 3: Patients with known central nervous system (CNS) lesions must not have any of the following:
1. Any untreated brain lesions > 1.0 cm in size
2. Any brainstem lesions
3. Ongoing use of systemic corticosteroids for control of symptoms of brain lesions at a total daily dose of > 10 mg of prednisone (or equivalent) prior to randomization.
4. Have poorly controlled (> 1/week) generalized or complex partial seizures, or manifest neurologic progression due to brain lesions notwithstanding CNS-directed therapy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified