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)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-515698-85-00

Acronym

CA239-0004

Enrollment

257

Registered

2025-06-03

Start date

2025-06-12

Completion date

Unknown

Last updated

2026-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally Advanced or Metastatic Non-small Cell Lung Cancer

Brief summary

To compare PFS of adagrasib + pembrolizumab + chemotherapy to placebo + pembrolizumab + chemotherapy., To compare OS of adagrasib + pembrolizumab + chemotherapy to placebo + pembrolizumab + chemotherapy.

Detailed description

PFS per RECIST v1.1 according to BICR.

Interventions

DRUGPEMBROLIZUMAB

DRUGPEMETREXED

DRUGCISPLATIN

DRUGtablets

DRUGCARBOPLATIN

DRUGPALONOSETRON

DRUGAdagrasib

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
To compare PFS of adagrasib + pembrolizumab + chemotherapy to placebo + pembrolizumab + chemotherapy., To compare OS of adagrasib + pembrolizumab + chemotherapy to placebo + pembrolizumab + chemotherapy.	—

Secondary

Measure	Time frame
PFS per RECIST v1.1 according to BICR.	—

Countries

Austria, Belgium, Bulgaria, Croatia, France, Germany, Greece, Hungary, Ireland, Italy, Netherlands, Poland, Portugal, Romania, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026