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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2051250009

Enrollment

550

Registered

2025-04-28

Start date

2025-07-10

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Non-small Cell Lung Cancer

Interventions

Phase 2 Portion -Cohort1a: Adagrasib 400mgBID -Cohort 1b: Adagrasib 600mgBID -Cohort 2: Adagrasib 400mgBID Phase 3 Portion -Investigational arm(Cohort 3): Adagrasib 400mg BID+ pembrolizumab 200 mg eve

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Untreated locally advanced or metastatic squamous and nonsquamous NSCLC with KRASG12C mutation -PD-L1 >= 50% -ECOG PS 0 or 1

Exclusion criteria

Exclusion criteria: -Prior systemic treatment for locally advanced or metastatic NSCLC including chemotherapy,immune CIT, or a therapy targetingKRASG12C mutation (eg,sotorasib). -Radiation to the lung >30 Gy within 6 months prior to the first dose of study treatment.

Design outcomes

Primary

Measure	Time frame
-PFS by BICR -Overall Survival (OS)	—

Secondary

Measure	Time frame
-PFS by Investigator -OR by Investigator and BICR -Duration of Response (DOR) by Investigator and BICR -Safety -Population PK parametersof adagrasib -Patient-reported outcome (PRO) scores -Lung Cancer Symptom Scale (LCSS) -EQ-5D-5L	—

Countries

Australia, Austria, Belgium, Bulgaria, Canada, Germany, Hungary, Ireland, Israel, Italy, Japan, Korea, Netherlands, Poland, Portugal, Spain, Taiwan, United Kingdom, United States

Contacts

Public ContactTschaika, Marina

Bristol-Myers Squibb

MG-JP-RCO-JRCT@bms.com+81-120-093-507

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026