Adagrasib vs Docetaxel for Non-Small Cell Lung Cancer

(KRYSTAL-12 Trial)

Recruiting at 711 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Mirati Therapeutics Inc.

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called adagrasib against an existing chemotherapy drug, docetaxel. It focuses on patients with advanced lung cancer who have a specific genetic mutation (KRAS G12C) and have already had treatment. The new drug aims to block this mutation in cancer cells to stop their growth.

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

This trial is for adults with advanced non-small cell lung cancer (NSCLC) that has a specific mutation called KRAS G12C. Participants must have tried chemotherapy with docetaxel, but their cancer still grew. They should be in decent physical shape (ECOG 0-2). People can't join if they've used other drugs targeting the KRAS G12C mutation, have active brain tumors, or received any other cancer treatments after docetaxel.

Inclusion Criteria

My lung cancer has a specific KRAS G12C mutation.

I am eligible to be treated with docetaxel.

I can take care of myself and am up and about more than half of the day.

Exclusion Criteria

I have been treated with a drug targeting KRAS G12C mutation.

I have active cancer spread to my brain.

I haven't taken any cancer treatment after my last docetaxel dose.

Treatment Details

Interventions

• Docetaxel (Cytotoxic Agent)
• MRTX849 (Adagrasib) (Small Molecule Drug)

Trial Overview The study compares MRTX849 (adagrasib), an experimental drug, to docetaxel, a standard chemotherapy drug. It's designed to see which one is better at controlling NSCLC in patients who already had treatment and whose tumor carries the KRAS G12C mutation.

Participant Groups

Group I: MRTX849 Experimental Treatment 1 Intervention

Group II: Docetaxel Active Control 1 Intervention

Who Is Running the Clinical Trial?

Mirati Therapeutics Inc.

Lead Sponsor

Trials

73

Recruited

8,900+

Dr. Charles M. Baum

Mirati Therapeutics Inc.

Chief Executive Officer since 2023

MD, PhD

Dr. Joseph Leveque

Mirati Therapeutics Inc.

Chief Medical Officer since 2021

MD