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Small Molecule Drug
Adagrasib vs Docetaxel for Non-Small Cell Lung Cancer (KRYSTAL-12 Trial)
Phase 3
Waitlist Available
Research Sponsored by Mirati Therapeutics Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically or cytologically confirmed diagnosis of NSCLC with KRAS G12C mutation
Candidacy to receive treatment with docetaxel
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 49 months
Awards & highlights
KRYSTAL-12 Trial Summary
This trial will compare the effectiveness of a new drug, MRTX849, to the current standard of care, docetaxel, in patients with a specific type of lung cancer.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Adagrasib may cause side effects like diarrhea, nausea, liver enzyme changes, fatigue and swelling. Docetaxel can lead to hair loss, low blood cell counts increasing infection risk, mouth sores and allergic reactions.
KRYSTAL-12 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lung cancer has a specific KRAS G12C mutation.
Select...
I am eligible to be treated with docetaxel.
Select...
I can take care of myself and am up and about more than half of the day.
Select...
My cancer has worsened after treatment with docetaxel.
KRYSTAL-12 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 49 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~49 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-free Survival (PFS)
Secondary outcome measures
1-year Survival Rate
Duration of Response (DOR)
Objective Response Rate (ORR)
+5 moreKRYSTAL-12 Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: MRTX849Experimental Treatment1 Intervention
Group II: DocetaxelActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MRTX849
2021
Completed Phase 1
~10
Find a Location
Who is running the clinical trial?
Mirati Therapeutics Inc.Lead Sponsor
70 Previous Clinical Trials
7,802 Total Patients Enrolled
Bill Paxton, MD PhDStudy DirectorMirati Therapeutics Inc.
Vicky Kang, MDStudy DirectorMirati Therapeutics Inc.
1 Previous Clinical Trials
806 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.My cancer has worsened after treatment with docetaxel.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.
Research Study Groups:
This trial has the following groups:- Group 1: MRTX849
- Group 2: Docetaxel
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Non-Small Cell Lung Cancer Patient Testimony for trial: Trial Name: NCT04685135 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals have enrolled in this clinical trial thus far?
"That is correct, the listing on clinicaltrials.gov currently states that this trial is recruiting patients. The posting date was April 1st, 2021 and the most recent update was November 4th, 2022. They are seeking a total of 340 individuals from 43 different locations."
Answered by AI
What is MRTX849's general therapeutic effect?
"MRTX849, while primarily used to treat malignant neoplasms, can also be effective in managing advance directives, sarcoma, and esophageal neoplasms."
Answered by AI
What other medical tests have included the use of MRTX849?
"As of now, there are a total of 341 studies underway that involve MRTX849. Out of those active trials, 133 have reached Phase 3 testing. Most research for MRTX849 is conducted in Fuzhou, Fujian; however, 23573 different locations worldwide are running clinical trials for this medication."
Answered by AI
Are people with the condition currently being sought for this trial?
"Indeed, this clinical trial is still underway and looking for participants. The posting dates on clinicaltrials.gov show that it was first advertised on April 1st, 2021 and updated November 4th, 2022."
Answered by AI
Could you walk me through the risks associated with MRTX849?
"The available data from Phase 3 trials support the safety of MRTX849, so it received a score of 3."
Answered by AI
Who else is applying?
What state do they live in?
Ohio
What site did they apply to?
Research Site
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I don't seem to be getting better. I have stage 2 lung cancer diagnosed in March of this year. I will start radiation probably next week. I am interested in clinical trials.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
Yes. When does it start? What qualifications do I need Doesthe trial pay anything?
PatientReceived 2+ prior treatments
How responsive is this trial?
Typically responds via
Phone Call
Most responsive sites:
- Research Site: < 48 hours
Average response time
- < 2 Days
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