Study on Adagrasib, Pembrolizumab, and Chemotherapy vs. Placebo, Pembrolizumab, and Chemotherapy for Untreated Non-Squamous Non-Small Cell Lung Cancer with KRAS G12C Mutation

Sponsor: Mirati Therapeutics Inc.

Sponsor score: 40

ClinicalTrials ID:NCT06875310

This clinical trial is testing a new combination of drugs, including Adagrasib and Pembrolizumab, with chemotherapy to see if it is more effective than a placebo with Pembrolizumab and chemotherapy in treating patients with advanced non-squamous non-small cell lung cancer (NSCLC) that has a specific KRAS G12C mutation.

Patient Parameters

Program Overview

The purpose of this study is to evaluate how well a new treatment combination works and how safe it is for patients with advanced non-squamous non-small cell lung cancer (NSCLC) that has not been treated before and has a specific genetic mutation called KRAS G12C. The study compares the effects of adding Adagrasib to Pembrolizumab and chemotherapy against using a placebo with Pembrolizumab and chemotherapy.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with non-squamous non-small cell lung cancer (NSCLC) that has a KRAS G12C mutation, confirmed by lab tests.
  • Cancer must be advanced or has spread to other parts of the body.
  • Must have at least one tumor that can be measured by a CT or MRI scan.
  • Have not received any previous treatment for advanced or metastatic cancer.
  • Not suitable for treatments like chemoradiation or complete surgical removal of the cancer.
  • Can have brain metastases if they are not causing symptoms and do not need immediate treatment. Any untreated brain metastases must be 20 mm or smaller.
  • Any level of PD-L1 expression is acceptable, as determined by specific lab tests.

Exclusion Criteria

  • Have an active or known autoimmune or inflammatory disease.
  • Have serious heart conditions that are not controlled, occurring within the last 6 months.
  • Have poor bone marrow or liver function or abnormal heart rhythms.
  • Taking medications that affect heart rhythm and cannot be changed before starting the study.
  • Have received treatments targeting the KRAS G12C mutation before.
  • Have other serious medical or mental health conditions that could increase risks during the study.
  • Other specific criteria may apply as defined by the study protocol.

Locations

FACILITYZIPCITYSTATE
Local Institution - 034735294-3300BirminghamAlabama
Local Institution - 058192835FullertonCalifornia
Local Institution - 020290805Long BeachCalifornia
Local Institution - 064392663Newport BeachCalifornia
Local Institution - 066692868OrangeCalifornia
Local Institution - 062393105Santa BarbaraCalifornia
Local Institution - 044280206DenverColorado
Local Institution - 065132610GainesvilleFlorida
Local Institution - 062132901Palm BayFlorida
Local Institution - 037733321TamaracFlorida

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