Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Adagrasib

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Cohort 1a: Adagrasib twice daily (BID) in combination with pembrolizumab

Cohort 2: Adagrasib BID in combination with pembrolizumab

Adagrasib BID in combination with pembrolizumab

Adagrasib 400 mg twice daily (BID) in combination with pembrolizumab (Cohort 1a)

Adagrasib 600 mg BID monotherapy (Cohort 1b)

adagrasib 400 mg BID in combination with pembrolizumab

Adagrasib 400 mg BID + pembrolizumab 200 mg every Q3W

Mirati Therapeutics Study Locator Services

Research Site

Barbara Wamil, MD

The Phase 2 portion of this study evaluates the efficacy and safety of MRTX849 monotherapy and in combination with pembrolizumab in cohorts of patients with advanced NSCLC with KRAS G12C mutation and any PD-L1 TPS and who are candidates for first-line treatment.

The Phase 3 portion of the study compares the efficacy of adagrasib in combination with pembrolizumab versus pembrolizumab in patients with unresectable, locally advanced or metastatic nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS \>=50% and who are candidates for first line treatment.

The Phase 2 portion of this study will evaluate the efficacy and safety of MRTX849 as monotherapy and in combination with pembrolizumab. There will be 3 cohorts of patients, all of whom have KRAS G12C mutation, have advanced or metastatic NSCLC, and are candidates for first-line treatment. 2 cohorts have PD-L1 TPS score \<1% and are randomized to MRTX849 monotherapy or MRTX849 in combination with pembrolizumab. The 3rd cohort has PD-L1 TPS score of 1% or higher and is treated with MRTX849 and pembrolizumab

The Phase 3 portion of the study will randomize patients with squamous or nonsquamous NSCLC with KRAS G12C mutation and TPS \>=50% in the first-line setting to adagrasib plus pembrolizumab or pembrolizumab. Primary efficacy objective is to compare efficacy between experimental and comparator arms. Secondary and exploratory objectives include evaluation of secondary efficacy endpoints, safety and tolerability, adagrasib PK, PROs, and correlative genomic biomarkers for the combination regimen in the study population.

MRTX849 is an orally available small molecule inhibitor of KRAS G12C, and Pembrolizumab (KEYTRUDA®) is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2.

MRTX849 Monotherapy, MRTX849 in Combination with Pembrolizumab and Pembrolizumab alone

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

A Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination With Pembrolizumab Versus Pembrolizumab in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation

Objective Response Rate (ORR) as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)

Progression Free Survival per RECIST 1.1 by Blinded Independent Central Review (BICR) and Overall Survival

Safety characterized by type, incidence, severity, timing, seriousness and relationship to study treatment of adverse events and laboratory abnormalities.

Defined as the time from date of the first documentation of objective tumor response (CR or PR) to the first documentation of either Progression of Disease (PD) or death due to any cause, whichever occurs first.

Defined as time from first study treatment until disease progression or death from any cause, whichever occurs first.

Pharmacokinetics (PK) Blood plasma Adagrasib and potential metabolite concentrations

Patient Reported Outcomes to measure quality of life

Defined as the percent of patients documented to have a confirmed CR or PR.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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	NCT04613596	Advanced Non-Sm... Metastatic Non-...	Adagrasib Adagrasib Adagrasib Adagrasib Pembrolizumab	18 Years -	Mirati Therapeutics Inc.
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	NCT04613596	Advanced Non-Sm... Metastatic Non-...	Adagrasib Adagrasib Adagrasib Adagrasib Pembrolizumab	18 Years -	Mirati Therapeutics Inc.

Spots Global Cancer Trial Database for krazati

Every month we try and update this database with for krazati cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for krazati

Every month we try and update this database with for krazati cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for krazati cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.