InformationClinical trials have complex eligibility criteria.
Always talk to your clinician about you’re interest in participating in a trial.
Learn why

Optimise reading forHealth ProfessionalsPatients

Closed (no longer recruiting)Last updated: 28 November 2023

This Phase II/III study is evaluating how safe and effective a new targeted therapy (MRTX849) is alone, and in combination with immunotherapy (pembrolizumab), in people with advanced or metastatic non-small cell lung cancer with KRAS G12C mutationA Phase 2 Trial of MRTX849 Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination With Pembrolizumab Versus Pembrolizumab Plus Chemotherapy in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation

Clinical summary

Summary

This study is being conducted in two parts, and each part has multiple cohorts of participants.

The Phase II portion of the study will evaluate the efficacy and safety of MRTX849 as monotherapy and when given in combination with pembrolizumab. There will be 3 cohorts of participants, all of whom have KRAS G12C mutation, have advanced or metastatic non-small cell lung cancer (NSCLC), and are candidates for first-line treatment. 2 cohorts of people who have a PD-L1 TPS score of < 1% and are randomised to receive either MRTX849 as monotherapy or MRTX849 in combination with pembrolizumab. The 3rd cohort will consist of people with PD-L1 score of 1% or higher, and they will receive MRTX849 + pembrolizumab.

The Phase III portion of the study will randomise people with non-squamous NSCLC with KRAS G12C mutation and TPS < 50% in the first-line setting to receive either MRTX849 + pembrolizumab, or pembrolizumab + chemotherapy.

 

**Note: In April 2023, Grampians Health is recruiting only people with PD-L1 TPS of < 1%**

Conditions

This trial is treating patients with advanced or metastatic non-small cell lung cancer with KRAS G12C mutation.

Cancer

Lung Cancers Lung cancer

Age

People18+

Phase

II/III

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Commercial Sponsor

Mirati Therapeutics Inc.

Scientific Title

A Phase 2 Trial of MRTX849 Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination With Pembrolizumab Versus Pembrolizumab Plus Chemotherapy in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation

Eligibility

Inclusion

  • 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 squamous or nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS >=50%
  • Phase 3: Presence of evaluable or measurable disease per RECIST
  • 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

Exclusion

  • 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., AMG 510).
  • 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
  • Phase 3: Radiation to the lung > 30 Gy within 6 months prior to the first dose of study treatment

Inclusion

  • You are able to swallow medication by mouth.
  • You have been diagnosed with cancer, but have not received any treatment.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

Participating hospitals

+ Show non-recruiting hospitals

Closed hospitals

InformationTell us if you find this trial availability is not accurate.Report inaccuracy

Get Support

Example

Cancer Connect

Speak with someone who has cancer clinical trial experience.

Learn more

Example

Cancer Council’s cancer nurses

If you need cancer information and practical support for yourself, a carer, family or friend, contact Cancer Council’s experienced cancer nurses on 131120.

Learn more

Example

Information for family, friends and carers

When you are considering a cancer clinical trial, it is a good idea to discuss it with your family, friends or carers.

Learn more

Victorian Cancer Registry Victorian Government

The Victorian Cancer Trials Link is supported by the Victorian Government through the Victorian Cancer Agency.

RAP

Cancer Council Victoria would like to acknowledge the traditional custodians of the land on which we live and work. We would also like to pay respect to the elders past and present and extend that respect to all other Aboriginal people.