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Trial of Two Adagrasib Dosing Regimens in NSCLC With KRAS G12C Mutation (KRYSTAL 21)

NCT05853575 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-03-27

No results posted yet for this study

Summary

This study will evaluate the efficacy of two dosing regimens of adagrasib (600 mg BID versus 400 mg BID) in patients with NSCLC with KRAS G12C mutation.

Conditions

Interventions

DRUG

Adagrasib

KRAS G12C inhibitor

Sponsors & Collaborators

  • Mirati Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-16
Primary Completion
2026-07-30
Completion
2026-07-30
FDA Drug
Yes

Countries

  • United States
  • Brazil
  • Croatia
  • France
  • Greece
  • Israel
  • Italy
  • Japan
  • Mexico
  • Netherlands
  • Poland
  • Romania
  • Serbia
  • South Korea
  • Spain
  • Taiwan
  • Thailand
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05853575 on ClinicalTrials.gov