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

Part of paid clinical trials in Santa Rosa, California.

Sponsor
Mirati Therapeutics Inc.
Study ID
NCT05853575
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Advanced Cancer
  • Malignant Neoplasm of Lung
  • Metastatic Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Feb 16, 2024
Status verified
Mar 2026
Primary completion
Jul 30, 2026
Completion
Jul 30, 2026

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Adagrasib 600mg BID
    Adagrasib 600mg BID without regard to food
  • Experimental: Adagrasib 400mg BID
    Adagrasib 400mg BID with food

Primary Outcome Measure

Objective Response Rate (ORR) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). [ Time Frame: 30 months ]

Locations (4)

FacilityCityStateZIPSite coordinators
Local Institution - 101Santa RosaCalifornia95403-
Local Institution - 105Kansas CityMissouri64128-
Local Institution - 100DurhamNorth Carolina27705-
Local Institution - 106DallasTexas75216-7167-

Find similar trials in Santa Rosa, CA

By research site
Local Institution - 101· Santa Rosa, CALocal Institution - 105· Kansas City, MOLocal Institution - 100· Durham, NCLocal Institution - 106· Dallas, TX

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