Adagrasib Plus Pembrolizumab for Lung Cancer Treatment

A Study of Adagrasib Plus Pembrolizumab Plus Chemotherapy vs. Placebo Plus Pembrolizumab Plus Chemotherapy in Participants With Previously Untreated Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation (KRYSTAL-4)

Recruiting Phase 3 Interventional Study
Carcinoma, Non-Small-Cell Lung
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
630 (estimated)
Sponsor
Mirati Therapeutics Inc. · Industry
Who this trial is looking for

This trial is looking for people with lung cancer who have a specific genetic mutation. Participants will receive a combination of three treatments to see how effective they are compared to another group receiving a different combination.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have been diagnosed with non-squamous non-small cell lung cancer.
  • I have a KRAS G12C mutation in my tumor.
  • I have locally advanced or metastatic disease.
  • I have at least one measurable lesion on a CT or MRI scan.
  • I have not received any prior systemic anti-cancer therapy.
  • I am not a candidate for definitive therapy.
  • I can participate even if I have untreated brain metastases that are asymptomatic and small.
  • I have any level of PD-L1 expression.

You may not be able to join if

  • I have an active autoimmune or inflammatory disease that needs treatment.
  • I have significant heart problems that are ongoing or may come back.
  • I have poor bone marrow or liver function.
  • I have ECG abnormalities.
  • I am currently taking medication that causes a prolonged QTc interval and cannot switch it.
  • I have been treated with medication targeting the KRAS G12C mutation before.
  • I have severe medical or psychiatric conditions that could increase risks.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About 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

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of non-squamous NSCLC with evidence of KRAS G12C mutation via tumor sample and/or circulating tumor deoxyribonucleic acid (ctDNA). * Locally advanced or metastatic disease. * Measurable disease via computed tomography (CT) or…
Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

855-907-3286

Clinical.Trials@bms.com

CONTACT

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CONTACT