🔎 Trials Near Me

Home › Non-Small Cell Lung Cancer › NCT06875310

A Study of Adagrasib Plus Pembrolizumab Plus Chemotherapy vs. Placebo Plus Pembrolizumab Plus Chemotherapy in Participants With Previously Untreated Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation (KRYSTAL-4)

RecruitingPhase 3

A Randomized, Double-Blind, Phase 3 Trial of Adagrasib Plus Pembrolizumab Plus Chemotherapy vs. Placebo Plus Pembrolizumab Plus Chemotherapy in Participants With Previously Untreated, Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation (KRYSTAL-4)

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of non-squamous NSCLC with evidence of KRAS G12C mutation via tumor sample and/or circulating tumor deoxyribonucleic acid (ctDNA).
* Locally advanced or metastatic disease.
* Measurable disease via computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST v1.1 criteria of at least 1 lesion.
* No prior systemic anti-cancer therapy given for advanced or metastatic disease.
* Not a candidate for definitive therapy (eg, chemoradiation or complete surgical resection).
* Participants with brain metastases are eligible for enrollment, including those with untreated brain metastases. Brain metastases must be asymptomatic and not in need of immediate local therapy. Any untreated brain metastases must be ≤ 20 mm in diameter.
* Any PD-L1 expression (0 to 100%) as determined by VENTANA PD-L1 (SP263) assay, Agilent PD-L1 IHC 22C3 pharmDx, or Agilent PD-L1 IHC 28-8 pharmDx.

Exclusion Criteria:

* Participants with an active autoimmune or inflammatory disease requiring systemic treatment within 2 years.
* Uncontrolled or significant cardiovascular conditions within 6 months prior to enrollment that are ongoing or with risk of recurrence.
* Inadequate bone marrow or liver function or electrocardiogram (ECG) abnormalities.
* Ongoing treatment with concomitant medication known to cause prolonged QTc interval and that cannot be switched to alternative treatment prior to study entry.
* Treatment targeting KRAS G12C mutation (eg, sotorasib, adagrasib) in any setting.
* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration.
* Other protocol-defined Inclusion/Exclusion criteria apply.

About the study

This is a trial to evaluate the efficacy, safety, and tolerability of adagrasib plus pembrolizumab plus platinum-doublet chemotherapy versus placebo plus pembrolizumab plus platinum-doublet chemotherapy in participants with previously untreated, locally advanced or metastatic NSCLC with KRAS G12C mutation

What is being tested

Sponsor: Mirati Therapeutics Inc. · Participants: 630 · Started: Apr 24, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06875310

Locations in the U.S.

AlabamaLocal Institution - 0347, Birmingham (Not yet recruiting)
ArkansasLocal Institution - 0686, Springdale (Not yet recruiting)
CaliforniaProvidence Medical Foundation, Fullerton
Local Institution - 0682, Loma Linda (Not yet recruiting)
Helios Clinical Research, Long Beach
ColoradoNational Jewish Health Medical Center, Denver
DelawareMedical Oncology Hematology Consultants, PA, Newark
FloridaLocal Institution - 0694, Clearwater (Not yet recruiting)
Cancer Specialists of North Florida, Jacksonville
Local Institution - 0696, Miami (Not yet recruiting)
Ocala Oncology Center PL DBA Florida Cancer Affiliates - Ocala, Ocala
Mid Florida Hematology and Oncology Center, Orange City
Cancer Care Centers of Brevard, Inc., Palm Bay
Florida Clinical Trials Group., Plantation
Local Institution - 0695, St. Petersburg (Not yet recruiting)
Florida Clinical Trials Group., Tamarac
H. Lee Moffitt Cancer Center & Research Institute, Tampa
Local Institution - 0647, Tampa (Not yet recruiting)
GeorgiaNorthwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital, Marietta
IllinoisIllinois Cancer Specialists, Arlington Heights
University of Illinois at Chicago, Chicago
Springfield Clinic Main Campus, Springfield
IndianaNorthwest Cancer Centers, P.C., Dyer
Parkview Research Center at Parkview Regional Medical Center, Fort Wayne
IowaMercy Medical Center, Cedar Rapids
KentuckySaint Elizabeth Medical Center Edgewood, Edgewood
The University of Louisville, James Graham Brown Cancer Center, Louisville
Owensboro Medical Health System, Owensboro
Mercy Health-Paducah Medical Oncology and Hematology, Paducah
LouisianaLouisiana State University Health Sciences Shreveport, Shreveport
MarylandLocal Institution - 0702, Annapolis (Not yet recruiting)
Maryland Oncology Hematology - Columbia, Columbia
MassachusettsLocal Institution - 0019, Boston (Not yet recruiting)
MichiganLocal Institution - 0293, Detroit (Not yet recruiting)
MissouriLocal Institution - 0685, Fenton (Not yet recruiting)
New YorkLocal Institution - 0678, Cooperstown (Not yet recruiting)
Ellis Hospital, Schenectady
White Plains Hospital, White Plains
North CarolinaLocal Institution - 0624, Asheville (Not yet recruiting)
PennsylvaniaLocal Institution - 0688, Easton (Not yet recruiting)
WellSpan Oncology Research, York
South CarolinaSt Francis Cancer Center, Greenville
TennesseeLocal Institution - 0697, Nashville (Not yet recruiting)
SCRI Oncology Partners, Nashville
TexasTexas Oncology Sammons Cancer Center, Dallas
Local Institution - 0692, Galveston (Not yet recruiting)
Local Institution - 0652, Laredo (Not yet recruiting)
Texas Oncology - San Antonio, San Antonio
Texas Oncology - Northeast Texas, Tyler

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.