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

Phase 2

Recruiting

• Conditions: Advanced NSCLC; Metastatic Lung Cancer

• Registration Number: NCT05609578
• Lead Sponsor: Mirati Therapeutics Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-1
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Cohort A* (closed): Has an untreated and unresectable or metastatic NSCLC with<br>histologically confirmed (squamous or nonsquamous) KRASG12C mutation and histologically<br>confirmed PD-L1 TPS =1%.<br><br> - Cohort C: Has an untreated and unresectable or metastatic NSCLC with histologically<br> confirmed (non-squamous only) KRASG12C mutation and histologically confirmed PD-L1<br> TPS < 50% AND previously completed 4 cycles of standard-of-care platinum based<br> induction chemotherapy with pembrolizumab AND experienced stable disease, partial<br> response, or complete response per investigator's assessment after 4 cycles OR if<br> patients received <4 cycles of a platinum-based induction, was stopped early due to<br> intolerable toxicity<br><br> - Cohort E: Has an untreated and unresectable or metastatic NSCLC with histologically<br> confirmed (non-squamous only) KRASG12C mutation and histologically confirmed PD-L1<br> TPS < 50%<br><br> - Presence of measurable disease per RECIST v1.1<br><br>Exclusion Criteria:<br><br> - All Cohorts: Any prior therapy targeting KRASG12C mutation in any setting<br><br> - Cohorts A & E: Prior systemic therapy for locally advanced or metastatic NSCLC,<br> including chemotherapy, immune checkpoint inhibitor therapy or chemoimmunotherapy<br> (note: prior systemic therapy or chemoradiation given in the adjuvant or neoadjuvant<br> setting are allowed if last dose of prior systemic treatment was >1 year prior to<br> first dose of study treatment)<br><br> - Cohort C: received maintenance therapy (e.g, pembrolizumab and/or pemetrexed<br> following completion of 4-6 cycles of a platinum-based regimen administered in the<br> first-line setting<br><br> - Radiation to the lung > 30 Gy within 6 months prior to first dose of study treatment<br><br> - Active brain metastases

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR) for Cohort A and E;Progression-free Survival (PFS) at six months for Cohort C

Secondary Outcome Measures

Name	Time	Method
Adverse Events;Duration of Response (DOR);Overall Survival (OS);Progression-free Survival (PFS);Population pharmacokinetic (PK) Model Derived AUC at Steady State (AUCtau,ss).;Cohorts C and E: DLTs during SLI (Safety Lead In)