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)

Description

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

Conditions

Carcinoma, Non-Small-Cell Lung

Study Overview

Study Details

Study overview

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

A Randomized, Double-Blind, Phase 3 Trial of Adagrasib Plus Pembrolizumab Plus Chemotherapy vs. Placebo Plus Pembrolizumab Plus Chemotherapy in Participants With Previously Untreated, Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation (KRYSTAL-4)

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)

Condition
Carcinoma, Non-Small-Cell Lung
Intervention / Treatment

-

Contacts and Locations

Birmingham

Local Institution - 0347, Birmingham, Alabama, United States, 35294-3300

Fullerton

Local Institution - 0581, Fullerton, California, United States, 92835

Long Beach

Local Institution - 0202, Long Beach, California, United States, 90805

Newport Beach

Local Institution - 0643, Newport Beach, California, United States, 92663

Orange

Local Institution - 0666, Orange, California, United States, 92868

Santa Barbara

Local Institution - 0623, Santa Barbara, California, United States, 93105

Denver

Local Institution - 0442, Denver, Colorado, United States, 80206

Gainesville

Local Institution - 0651, Gainesville, Florida, United States, 32610

Palm Bay

Local Institution - 0621, Palm Bay, Florida, United States, 32901

Tamarac

Local Institution - 0377, Tamarac, Florida, United States, 33321

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Histologically or cytologically confirmed diagnosis of non-squamous NSCLC with evidence of KRAS G12C mutation via tumor tissue and/or circulating tumor deoxyribonucleic acid (ctDNA).
  • * Locally advanced or metastatic disease.
  • * Measurable disease via computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST v1.1 criteria of at least 1 lesion.
  • * No prior systemic anti-cancer therapy given for advanced or metastatic disease.
  • * Not a candidate for definitive therapy (eg, chemoradiation or complete surgical resection).
  • * Participants with brain metastases are eligible for enrollment, including those with untreated brain metastases. Brain metastases must be asymptomatic and not in need of immediate local therapy. Any untreated brain metastases must be ≤ 20 mm in diameter.
  • * Any PD-L1 expression (0 to 100%) as determined by VENTANA PD-L1 (SP263) assay, Agilent PD-L1 IHC 22C3 pharmDx, or Agilent PD-L1 IHC 28-8 pharmDx.
  • * Participants with an active, known, prior documented, or suspected autoimmune or inflammatory disease.
  • * Uncontrolled or significant cardiovascular conditions within 6 months prior to enrollment.
  • * Inadequate bone marrow or liver function or electrocardiogram (ECG) abnormalities.
  • * Ongoing treatment with concomitant medication known to cause prolonged QTc interval and that cannot be switched to alternative treatment prior to study entry.
  • * Treatment targeting KRAS G12C mutation (eg, sotorasib, adagrasib) in any setting.
  • * Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration.
  • * Other protocol-defined Inclusion/Exclusion criteria apply.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Mirati Therapeutics Inc.,

Study Record Dates

2032-04-30