Adagrasib + Pembrolizumab for Non-Small Cell Lung Cancer

Recruiting in Palo Alto (17 mi)

+275 other locations

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Mirati Therapeutics Inc.

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This is a trial to evaluate the efficacy, safety, and tolerability of adagrasib plus pembrolizumab plus platinum-doublet chemotherapy versus placebo plus pembrolizumab plus platinum-doublet chemotherapy in participants with previously untreated, locally advanced or metastatic NSCLC with KRAS G12C mutation

Eligibility Criteria

This trial is for adults with advanced non-squamous non-small cell lung cancer that has a specific mutation (KRAS G12C) and haven't been treated before. Participants should be fit enough for chemotherapy, but those with certain health conditions or previous treatments are excluded.

Inclusion Criteria

My non-squamous NSCLC has a KRAS G12C mutation.

My cancer can be measured on scans.

I haven't had any drug treatments for cancer that has spread.

I cannot undergo surgery or combined chemotherapy and radiation for my condition.

My cancer has spread beyond its original location.

My cancer shows some level of PD-L1 expression.

Exclusion Criteria

I have been treated with drugs targeting the KRAS G12C mutation.

I have or might have an autoimmune or inflammatory disease.

My bone marrow, liver function, or heart rhythm is not normal.

I am on medication that affects my heart's rhythm and cannot change it.

Participant Groups

The study tests if adding Adagrasib to the standard treatment of Pembrolizumab plus platinum-based chemo (like Cisplatin or Carboplatin) is better than using a placebo with the standard treatment in patients with this type of lung cancer.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: AdagrasibExperimental Treatment5 Interventions

Group II: PlaceboPlacebo Group5 Interventions