NCT06875310|RecruitingPhase 3DMCFDA Drug

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)

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)

Mirati Therapeutics Inc.ClinicalTrials.gov

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2 other identifiers

CA239-0004CA2390004

Study Type

interventional

Target

630

Locations

34 countries

Sites

346

Timeline

RegisteredMar 2025

StartedApr 2025

CompletionApr 2032

Brief Summary

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

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

630

participants targeted

Target at P75+ for phase_3

Timeline

72mo left

Started Apr 2025

Longer than P75 for phase_3

Geographic Reach

34 countries

346 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

7 years study duration

Study Progress15%

Apr 2025Apr 2032

First Submitted

Initial submission to the registry

March 7, 2025

Completed

6 days until next milestone

First Posted

Study publicly available on registry

March 13, 2025

Completed

1 month until next milestone

Study Start

First participant enrolled

April 24, 2025

Completed

4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 7, 2029

Expected

2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2032

Last Updated

April 27, 2026

Status Verified

April 1, 2026

Enrollment Period

4.4 years

First QC Date

March 7, 2025

Last Update Submit

April 24, 2026

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

ImmunotherapyKRASKRAS G12CTargeted therapy

Outcome Measures

Primary Outcomes (2)

Progression Free Survival (PFS) as Assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Blinded Independent Central Review (BICR)
Up to 7 years
Overall Survival (OS)
Up to 7 years

Secondary Outcomes (11)

Overall Response (OR) as Assessed per RECIST v1.1 by BICR
Up to 7 years
Duration of Response (DOR) as Assessed per RECIST 1.1 by BICR
Up to 7 years
PFS as Assessed per RECIST v1.1 by Investigator
Up to 7 years
Number of Participants With Adverse Events (AEs)
Up to 90 days from last dose
Number of Participants With Serious Adverse Events (SAEs)
Up to 90 days from last dose
+6 more secondary outcomes

Study Arms (2)

Adagrasib

EXPERIMENTAL

Drug: AdagrasibDrug: PembrolizumabDrug: CarboplatinDrug: PemetrexedDrug: Cisplatin

Placebo

PLACEBO COMPARATOR

Drug: PembrolizumabDrug: CarboplatinDrug: PemetrexedDrug: PlaceboDrug: Cisplatin