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 · tracked via the Priya Life Science USA tracker

Sponsor

Mirati Therapeutics Inc.

Phase

Phase 2/3

Started

2020-12-02

Last updated

2026-09-16

Condition(s) studied

Advanced Non-Small Cell Lung CancerMetastatic Non-Small Cell Lung Cancer

Investigational drug(s) / intervention(s)

AdagrasibAdagrasibAdagrasibAdagrasibPembrolizumab

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

Adagrasib: Adagrasib 600 mg BID monotherapy (Cohort 1b)

Adagrasib: adagrasib 400 mg BID in combination with pembrolizumab

Adagrasib: Adagrasib 400 mg BID + pembrolizumab 200 mg every Q3W

Pembrolizumab: Pembrolizumab 200 mg IV Q3W

Study summary

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 squamous or nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS \>=50% and who are candidates for first line treatment.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * 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% * Phase 3: Presence of measurable disease per RECIST1.1 * Phase 3: CNS Inclusion - Based on screening brain imaging, patients must have one of the following: 1. No evidence of brain metastases 2. Untreated brain metastases not needing immediate local therapy 3. Previously treated brain metastases not needing immediate local therapy Exclusion Criteria: * Phase 2 and Phase 3: Prior systemic treatment for locally advanced or metastatic NSCLC including chemotherapy, immune checkpoint inhibitor therapy, or a therapy targeting KRAS G12C mutation (e.g., AMG 510). * Phase 2: Active brain metastases * Phase 3: Patients with known central nervous system (CNS) lesions must not have any of the following: 1. Any untreated brain lesions \> 2.0 cm in size 2. Any brainstem lesions 3. Ongoing use of systemic corticosteroids for control of symptoms of brain lesions at a total daily dose of \> 10 mg of prednisone (or equivalent) prior to randomization. 4. Have poorly controlled (\> 1/week) generalized or complex partial seizures, or manifest neurologic progression due to brain lesions notwithstanding CNS-directed therapy * Phase 3: Radiation to the lung \> 30 Gy within 6 months prior to the first dose of study treatment

Primary outcome measure(s)

Phase 2: To evaluate the efficacy of Adagrasib monotherapy and in combination with pembrolizumab administered to patients having advanced/metastatic NSCLC. — 22 months
Objective Response Rate (ORR) as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
Phase 3: To compare efficacy of Adagrasib in combination with pembrolizumab versus pembrolizumab — 36 months
Progression Free Survival per RECIST 1.1 by Blinded Independent Central Review (BICR) and Overall Survival

Trial sites (770)

Facility	City	Region	Status
Local Institution - 007-556-A	Goodyear	Arizona	Not Yet Recruiting
USOR - Arizona Oncology - Prescott Valley	Prescott Valley	Arizona	Recruiting
Local Institution - 007-568-A	Safford	Arizona	Not Yet Recruiting
Local Institution - 007-568-B	Safford	Arizona	Not Yet Recruiting
Local Institution - 007-568-C	Safford	Arizona	Not Yet Recruiting
Local Institution - 007-568-D	Safford	Arizona	Not Yet Recruiting
Local Institution - 007-568-E	Safford	Arizona	Not Yet Recruiting
Arizona Clinical Research Center	Tucson	Arizona	Recruiting
Highlands Oncology Group - Springdale	Springdale	Arkansas	Recruiting
Providence - Saint Joseph Home Health - Anaheim	Anaheim	California	Recruiting
The Oncology Institute of Hope and Innovation - Corporate Office	Cerritos	California	Recruiting
Local Institution - 007-777	Fountain Valley	California	Not Yet Recruiting
Local Institution - 007-778	Laguna Hills	California	Not Yet Recruiting
Local Institution - 007-898-B	Long Beach	California	Not Yet Recruiting
MemorialCare - Long Beach Medical Center	Long Beach	California	Recruiting
TRIO - Cancer & Blood Specialty Clinic - Los Alamitos	Los Alamitos	California	Recruiting
Local Institution - 007-579	Los Angeles	California	Withdrawn
Local Institution - Unk045	Rancho Mirage	California	Active Not Recruiting
San Francisco Veterans Affairs Medical Center	San Francisco	California	Recruiting
UCSF Helen Diller Family Comprehensive Cancer Center	San Francisco	California	Recruiting
Local Institution - 007-898-C	Santa Ana	California	Not Yet Recruiting
Providence Medical Group - Santa Rosa	Santa Rosa	California	Recruiting
Stockton Hematology Oncology Medical Group (SHOMG) - Stockton (Suite B)	Stockton	California	Recruiting
Local Institution - 007-898-A	Whittier	California	Not Yet Recruiting
Local Institution - 007-872-H	Aurora	Colorado	Not Yet Recruiting
Local Institution - 007-872-D	Boulder	Colorado	Not Yet Recruiting
Local Institution - 007-872-L	Centennial	Colorado	Not Yet Recruiting
Local Institution - 007-872-C	Colorado Springs	Colorado	Not Yet Recruiting
Local Institution - 007-872-K	Colorado Springs	Colorado	Not Yet Recruiting
Local Institution - 007-872-E	Denver	Colorado	Not Yet Recruiting
Local Institution - 007-872-I	Denver	Colorado	Not Yet Recruiting
Local Institution - 007-872-A	Lakewood	Colorado	Not Yet Recruiting
Local Institution - 007-872-J	Littleton	Colorado	Not Yet Recruiting
USOR - Rocky Mountain Cancer Centers - Lone Tree	Lone Tree	Colorado	Recruiting
Local Institution - 007-872-G	Longmont	Colorado	Not Yet Recruiting
Local Institution - 007-872-B	Pueblo	Colorado	Not Yet Recruiting
Local Institution - 007-872-F	Thornton	Colorado	Not Yet Recruiting
Eastern Connecticut Hematology and Oncology Associates	Norwich	Connecticut	Recruiting
Local Institution - 007-5476	Washington D.C.	District of Columbia	Not Yet Recruiting
GenesisCare USA	Aventura	Florida	Recruiting

+ 730 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04613596 on ClinicalTrials.gov ↗ ← All trials in the USA