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Small Molecule Drug

Adagrasib for KRAS-Mutated Lung Cancer

Phase 2
Recruiting
Research Sponsored by Mirati Therapeutics Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Are at least 18 years old (or old enough to legally make their own treatment decisions, according to local laws)
Have had previous treatment with chemotherapy that included cisplatin or carboplatin and a type of drug called an immune checkpoint inhibitor
Must not have
Have had previous treatment with a drug that targets KRAS G12C
Patients with brain lesions are not eligible if any untreated brain lesions are > 2.0 cm in size, any brainstem lesions are present, ongoing steroid dosing >10 mg daily prednisone (or equivalent), or poorly controlled (> 1/week) generalized or complex partial seizures or neurologic progression/instability due to brain lesions
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-dose and 4-6 hours post dose; up to 6 months.
Awards & highlights
No Placebo-Only Group

Summary

This trial will test two doses of a drug to treat lung cancer caused by a gene mutation.

Who is the study for?
This trial is for adults with advanced or metastatic NSCLC who have the KRAS G12C mutation and previously underwent chemotherapy including cisplatin or carboplatin, plus immune checkpoint inhibitors. They should be recovered from prior treatments with safe blood test levels. Those ineligible include patients who could undergo surgery to remove cancer, those treated before with KRAS G12C targeting drugs, individuals with certain medical conditions or on conflicting medications, pregnant women, and patients with specific brain lesions.
What is being tested?
The KRYSTAL 21 study is testing two different doses of a drug called Adagrasib (600 mg twice daily vs. 400 mg twice daily) in patients who have non-small cell lung cancer (NSCLC) that carries a specific genetic change known as the KRAS G12C mutation.
What are the potential side effects?
While not explicitly listed here, common side effects of targeted therapies like Adagrasib may include diarrhea, fatigue, nausea and liver enzyme elevation. Side effects can vary based on individual patient factors.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am at least 18 years old or legally considered an adult.
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I've been treated with chemotherapy involving cisplatin or carboplatin and an immune therapy.
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My advanced lung cancer has the KRAS G12C mutation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been treated with a drug for KRAS G12C mutation.
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I don't have large untreated brain lesions, brainstem lesions, high steroid use, or frequent seizures due to brain lesions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-dose and 4-6 hours post dose; up to 6 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose and 4-6 hours post dose; up to 6 months. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Objective Response Rate (ORR) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).
Secondary study objectives
Evaluate Duration of Response (DOR).
Evaluate Overall Survival (OS).
Evaluate Progression Free Survival (PFS).
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Adagrasib 600mg BIDExperimental Treatment1 Intervention
Adagrasib 600mg BID without regard to food
Group II: Adagrasib 400mg BIDExperimental Treatment1 Intervention
Adagrasib 400mg BID with food
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Adagrasib
2023
Completed Phase 1
~20

Find a Location

Who is running the clinical trial?

Mirati Therapeutics Inc.Lead Sponsor
70 Previous Clinical Trials
7,929 Total Patients Enrolled
Julie Meade, MDStudy DirectorMirati Therapeutics
1 Previous Clinical Trials
453 Total Patients Enrolled
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,582 Previous Clinical Trials
3,388,486 Total Patients Enrolled

Media Library

Adagrasib (Small Molecule Drug) Clinical Trial Eligibility Overview. Trial Name: NCT05853575 — Phase 2
Lung Cancer Research Study Groups: Adagrasib 600mg BID, Adagrasib 400mg BID
Lung Cancer Clinical Trial 2023: Adagrasib Highlights & Side Effects. Trial Name: NCT05853575 — Phase 2
Adagrasib (Small Molecule Drug) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05853575 — Phase 2
~46 spots leftby Mar 2025
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