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Small Molecule Drug
Adagrasib Combo Therapy for Lung Cancer (202200050434 Trial)
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
Cohort A: Untreated and unresectable or metastatic NSCLC with histologically confirmed KRASG12C mutation and histologically confirmed PD-L1 TPS ≥1%
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time frame: pre-dose and 4-6 hours post dose; up to 6 months
Awards & highlights
202200050434 Trial Summary
This trial tests a drug combo to treat advanced lung cancer with a genetic mutation.
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 measurable disease and varying levels of PD-L1 expression, depending on the cohort they fall into. They should not have received certain prior treatments for NSCLC or have active brain metastases.Check my eligibility
What is being tested?
The study tests adagrasib combined with pembrolizumab and chemotherapy (pemetrexed, cisplatin/carboplatin) in patients with NSCLC who haven't been treated before or those who've had stable disease after initial chemo. It's an open-label Phase 2 trial to see how well this combination works.See study design
What are the potential side effects?
Possible side effects include fatigue, nausea, diarrhea, liver enzyme changes, skin rash, and potential immune-related issues like inflammation of organs due to pembrolizumab.
202200050434 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My NSCLC is untreated, can't be surgically removed, has a KRASG12C mutation, and PD-L1 TPS is 1% or more.
202200050434 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ time frame: pre-dose and 4-6 hours post dose; up to 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time frame: pre-dose and 4-6 hours post dose; up to 6 months
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) for Cohort A and E
Progression-free Survival (PFS) at six months for Cohort C
Secondary outcome measures
Adverse Events
Cohorts C and E: DLTs during SLI (Safety Lead In)
Duration of Response (DOR)
+3 more202200050434 Trial Design
3Treatment groups
Experimental Treatment
Group I: Cohort EExperimental Treatment4 Interventions
Adagrasib 400 mg BID + pembrolizumab 200 mg Q3W + pemetrexed 500 mg/m2 + cisplatin 75 mg/m2 Q3W OR carboplatin AUC 5 Q3W for 4 cycles, followed by adagrasib 400 mg BID + pemetrexed 500 mg/m2 Q3W + pembrolizumab 200 mg Q3W (up to 31 cycles)
Group II: Cohort CExperimental Treatment4 Interventions
Adagrasib 400 mg BID + pemetrexed 500 mg/m2 Q3W + pembrolizumab 200 mg Q3W up to 31 cycles
Group III: Cohort A: PD-L1 TPS≥ 1% (Closed)Experimental Treatment1 Intervention
Adagrasib 400 mg BID for 2 cycles followed by adagrasib 400 mg BID + pembrolizumab 200 mg every 3 weeks (Q3W) up to 35 cycles
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Cisplatin/Carboplatin
2015
Completed Phase 3
~280
Find a Location
Who is running the clinical trial?
Mirati Therapeutics Inc.Lead Sponsor
70 Previous Clinical Trials
8,115 Total Patients Enrolled
Viola Chen, MDStudy DirectorMirati Therapeutics Inc.
2 Previous Clinical Trials
876 Total Patients Enrolled
Study DirectorStudy DirectorMirati Therapeutics Inc.
1,211 Previous Clinical Trials
489,263 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I received maintenance therapy with pembrolizumab or pemetrexed after initial platinum-based treatment.I have not had lung radiation over 30 Gy in the last 6 months.I have NSCLC with a KRASG12C mutation, PD-L1 < 50%, and responded to or couldn't tolerate initial chemotherapy.My NSCLC is untreated, can't be surgically removed, has a KRASG12C mutation, and PD-L1 TPS is below 50%.My NSCLC is untreated, can't be surgically removed, has a KRASG12C mutation, and PD-L1 TPS is 1% or more.I've had treatment for advanced lung cancer but not within the last year.You have a disease that can be measured using a specific set of guidelines.I have active cancer spread to my brain.I have never received treatment targeting the KRASG12C mutation.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort A: PD-L1 TPS≥ 1% (Closed)
- Group 2: Cohort C
- Group 3: Cohort E
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many people are included in the experimental group for this research?
"That is correct, the listing on clinicaltrials.gov currently says that this trial is recruiting patients. The first posting was on 7/29/2022 and there have been edits made as recently as 11/1/2022. They are hoping to enroll a total of 90 individuals at 1 location."
Answered by AI
Could you explain the risks associated with Cohort B: PD-L1 TPS≥ 1% for patients?
"Cohort B: PD-L1 TPS≥ 1% was given a 2 because while there is data supporting its safety, none of the evidence collected thus far suggests that it is an effective medication."
Answered by AI
Is this test group still recruiting new participants?
"That is correct. The clinical trial website has the most recent information which indicates that the study is looking for 90 individuals to take part in research at 1 location."
Answered by AI
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