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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre-dose and 4-6 hours post dose; up to 6 months.

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-dose and 4-6 hours post dose; up to 6 months.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Objective Response Rate (ORR) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).

Secondary outcome measures

Evaluate Duration of Response (DOR).

Evaluate Overall Survival (OS).

Evaluate Progression Free Survival (PFS).

+4 more

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mirati Therapeutics Inc.Lead Sponsor

70 Previous Clinical Trials

8,005 Total Patients Enrolled

Julie Meade, MDStudy DirectorMirati Therapeutics

1 Previous Clinical Trials

453 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this investigation currently admitting new participants?

"Clinicaltrials.gov reports that this trial, which was initially posted on April 5th 2023, is actively recruiting participants. The study's details have been recently amended as of May 2nd 2023."

Answered by AI

What adverse effects have been observed with Adagrasib 600mg BID?

"Given the lack of efficacy data and presence of safety information, our team ranked Adagrasib 600mg BID a 2 on the scale from 1 to 3."

Answered by AI

What is the upper limit for participants in this trial?

"Affirmative. The public information on clinicaltrials.gov confirms that this experimental research is currently recruiting participants, with 200 individuals needed from 1 separate centre. This project was initially posted to the website on April 5th 2023 and most recently updated two months later on May 2nd 2023."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Trial of Two Adagrasib Dosing Regimens in NSCLC With KRAS G12C Mutation (KRYSTAL 21)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05853575.

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