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Small Molecule Drug

Adagrasib + Pembrolizumab for Lung Cancer

Phase 2 & 3
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
Phase 2: Histologically confirmed diagnosis of unresectable or metastatic NSCLC with KRAS G12C mutation and any PD-L1 TPS
Phase 3: Histologically confirmed diagnosis of unresectable or metastatic squamous or nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS >=50%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights

Study Summary

This trial is testing a new cancer drug, MRTX849, to see if it is effective in treating patients with advanced lung cancer who have a specific gene 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 no prior treatments for metastatic NSCLC. Those with certain brain metastases can join if they don't require immediate treatment.Check my eligibility
What is being tested?
The study tests MRTX849 alone and combined with Pembrolizumab in Phase 2, while Phase 3 compares Adagrasib plus Pembrolizumab against only Pembrolizumab in patients whose tumors show high levels of a protein called PD-L1.See study design
What are the potential side effects?
Possible side effects include fatigue, nausea, diarrhea, skin rash, liver enzyme changes, and potential immune-related issues such as inflammation of organs or infusion reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My NSCLC is inoperable or has spread, with a KRAS G12C mutation.
Select...
My NSCLC is inoperable or has spread, with a KRAS G12C mutation and high PD-L1 levels.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 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
Phase 2: To evaluate the efficacy of Adagrasib monotherapy and in combination with pembrolizumab administered to patients having advanced/metastatic NSCLC.
Phase 3: To compare efficacy of Adagrasib in combination with pembrolizumab versus pembrolizumab
Secondary outcome measures
Phase 2: Duration of Response
Phase 2: Progression Free Survival
Phase 2: To characterize the safety and tolerability of study treatments in selected populations
+8 more

Trial Design

5Treatment groups
Experimental Treatment
Active Control
Group I: Phase 3 Cohort 3 Investigational ArmExperimental Treatment1 Intervention
Adagrasib BID in combination with pembrolizumab
Group II: Phase 2 Cohort 2: PD-L1 TPS ≥1%Experimental Treatment1 Intervention
Cohort 2: Adagrasib BID in combination with pembrolizumab
Group III: Phase 2 Cohort 1b: PD-L1 TPS <1%Experimental Treatment1 Intervention
Cohort 1b: Adagrasib BID monotherapy
Group IV: Phase 2 Cohort 1a: PD-L1 TPS <1%Experimental Treatment1 Intervention
Cohort 1a: Adagrasib twice daily (BID) in combination with pembrolizumab
Group V: Phase 3 Cohort 4 Comparator ArmActive Control1 Intervention
Pembrolizumab
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
7,399 Total Patients Enrolled
Richard Chao, MDStudy DirectorMirati Therapeutics Inc.
2 Previous Clinical Trials
272 Total Patients Enrolled
Richard L Chao, MDStudy DirectorMirati Therapeutics Inc.

Media Library

Adagrasib (Small Molecule Drug) Clinical Trial Eligibility Overview. Trial Name: NCT04613596 — Phase 2 & 3
Non-Small Cell Lung Cancer Research Study Groups: Phase 3 Cohort 4 Comparator Arm, Phase 3 Cohort 3 Investigational Arm, Phase 2 Cohort 1a: PD-L1 TPS <1%, Phase 2 Cohort 1b: PD-L1 TPS <1%, Phase 2 Cohort 2: PD-L1 TPS ≥1%
Non-Small Cell Lung Cancer Clinical Trial 2023: Adagrasib Highlights & Side Effects. Trial Name: NCT04613596 — Phase 2 & 3
Adagrasib (Small Molecule Drug) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04613596 — Phase 2 & 3

Frequently Asked Questions

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

Are there openings for participants in this experiment?

"According to clinicaltrials.gov, this trial is presently seeking participants with enrollment commencing December 2nd 2020 and the latest update occurring November 21st 2022."

Answered by AI

How many locations are participating in the implementation of this clinical trial?

"At this time, 90 clinical trial sites are actively recruiting patients. Locations include Richmond, Covington, and Las Vegas - among many other locales. To minimize the potential for travel obligations, it is ideal to select a location closest to you if participation in the study is desired."

Answered by AI

What medical conditions are MRTX849 in Combination with Pembrolizumab typically prescribed for?

"The antiviral MRTX849, when administered in conjunction with pembrolizumab, is sometimes used to combat malignant neoplasms. Additional conditions that this treatment combination can be employed for include unresectable melanoma, microsatellite instability high and progression of disease after chemotherapy has been attempted."

Answered by AI

What objectives is this research endeavor attempting to reach?

"According to the trial sponsor, Mirati Therapeutics Inc., this clinical study will measure primary outcomes over a 22 month period, including Evaluating the efficacy of MRTX849 in combination with pembrolizumab. Secondary objectives are assessing safety profiles and pharmacokinetic characteristics of MRTX849 when administered as monotherapy or combined with pembrolizumab and measuring duration of response."

Answered by AI

Has the FDA authorized MRTX849 coupled with Pembrolizumab for medical use?

"The safety of using MRTX849 alongside pembrolizumab has been supported by preliminary clinical data and thus, it receives a score of 2."

Answered by AI

How many individuals are receiving treatment within this research program?

"The trial necessitates 250 eligible patients. Those looking to join can seek the trial out of locations like Virginia Cancer Institute in Richmond, VA and Pontchartrain Cancer Center - Covington Office in Covington, LA."

Answered by AI

What other experiments have examined the effects of MRTX849 in tandem with Pembrolizumab?

"Currently, there are 965 medical trials assessing the effects of MRTX849 in Combination with Pembrolizumab; 124 of which have reached Phase 3. Houston, Texas is at the focal point for these investigations and 36174 sites around the world participate in this research."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7
2020. "Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04613596.
All > Lung Cancer Boston
~463 spots leftby Oct 2028
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