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

Mirati Therapeutics, Inc.0 个研究点目标入组 806 人开始时间: 2023年4月3日最近更新: 2024年4月15日

适应症

试验速览

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•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

•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

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