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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
Must not have
Prior treatment with an agent targeting KRAS G12C (e.g., AMG 510, Sotorasib)
Active brain metastases
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 49 months
Awards & highlights
Summary
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.
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.
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been treated with a drug targeting KRAS G12C mutation.
Select...
I have active cancer spread to my brain.
Select...
I haven't taken any cancer treatment after my last docetaxel dose.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 49 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~49 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Progression-free Survival (PFS)
Secondary study objectives
Duration of Response (DOR)
Objective Response Rate (ORR)
Overall Survival (OS)
+4 moreTrial 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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Non-Small Cell Lung Cancer (NSCLC) include targeted therapies, immunotherapies, and chemotherapy. Targeted therapies, such as EGFR inhibitors (osimertinib) and ALK inhibitors (crizotinib), work by blocking specific molecules involved in cancer cell growth and survival.
KRAS G12C inhibitors like MRTX849 (adagrasib) specifically target the KRAS G12C mutation, which is a common driver in NSCLC, thereby inhibiting cancer cell proliferation. Immunotherapies, such as PD-1/PD-L1 inhibitors (nivolumab, pembrolizumab), enhance the immune system's ability to recognize and destroy cancer cells.
Chemotherapy, using agents like cisplatin and paclitaxel, kills rapidly dividing cells, including cancer cells. Understanding these mechanisms is crucial for NSCLC patients as it allows for personalized treatment plans that target the specific genetic and molecular characteristics of their cancer, potentially improving outcomes and reducing side effects.
Emerging therapeutic agents for lung cancer.The efficacy of combining antiangiogenic agents with chemotherapy for patients with advanced non-small cell lung cancer who failed first-line chemotherapy: a systematic review and meta-analysis.
Emerging therapeutic agents for lung cancer.The efficacy of combining antiangiogenic agents with chemotherapy for patients with advanced non-small cell lung cancer who failed first-line chemotherapy: a systematic review and meta-analysis.
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Who is running the clinical trial?
Mirati Therapeutics Inc.Lead Sponsor
70 Previous Clinical Trials
7,676 Total Patients Enrolled
Yan Zhang, MD/PHDStudy DirectorMirati Therapeutics Inc.
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,563 Previous Clinical Trials
3,383,715 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
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