Phase II study of MRTX849 monotherapy and in combination with pembrolizumab in patients with advanced non-small-cell lung cancer with KRAS G12C mutation

A Phase II trial of MRTX849 monotherapy and in combination with pembrolizumab in patients with advanced non-small-cell lung cancer with KRAS G12C mutation

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN13464104

Enrollment

250

Registered

2022-05-03

Start date

2020-11-23

Completion date

Unknown

Last updated

2022-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced non-small cell lung cancer Cancer

Interventions

This is a study involving an investigational (experimental) medication called MRTX849, being developed by Mirati Therapeutics, Inc. In this study, participants will be administered MR

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histologically confirmed diagnosis of NSCLC (squamous or nonsquamous) with KRAS G12C mutation and known PD-L1 Tumor Proportion Score (TPS) score 2. Unresectable or metastatic disease

Exclusion criteria

Exclusion criteria: 1. Prior systemic treatment for locally advanced or metastatic NSCLC including chemotherapy, immune checkpoint inhibitor therapy, or a therapy targeting KRAS G12C mutation (e.g., AMG 510) 2. Active brain metastases

Design outcomes

Primary

Measure	Time frame
Objective Response Rate (ORR) assessed using Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 at 22 months	—

Secondary

Measure	Time frame
1. Safety characterized by type, incidence, severity, timing, seriousness and relationship to study treatment of adverse events and laboratory abnormalities at 22 months 2. Duration of response (DOR) estimated using the Kaplan-Meier method at 22 months 3. Pharmacokinetics (PK) of MRTX849 administered as monotherapy and in combination with pembrolizumab by measuring blood plasma MRTX849 and potential metabolite concentrations at 22 months	—

Measure

Time frame

1. Safety characterized by type, incidence, severity, timing, seriousness and relationship to study treatment of adverse events and laboratory abnormalities at 22 months 2. Duration of response (DOR) estimated using the Kaplan-Meier method at 22 months 3. Pharmacokinetics (PK) of MRTX849 administered as monotherapy and in combination with pembrolizumab by measuring blood plasma MRTX849 and potential metabolite concentrations at 22 months

—

Countries

Australia, Austria, Belgium, Canada, China, England, Germany, Hungary, Ireland, Israel, Italy, Netherlands, New Zealand, Poland, Portugal, Scotland, Singapore, Spain, Taiwan, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026