KEYMAKER-U01 Substudy 01J: A Randomized Phase 2 Umbrella Study With Rolling Arms of Investigational Agents for First-line Treatment of Participants With Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With KRAS G12C Mutations

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-521939-36-00

Enrollment

Registered

2026-02-24

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-25

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

Conditions

Participants with KRAS G12C-Mutant, Advanced or Metastatic Nonsquamous NSCLC

Brief summary

Percentage of Participants with a Dose Limiting Toxicity (DLT), Percentage of Participants who Experience at Least One Adverse Event (AE), Percentage of Participants who Discontinue Study Intervention Due to an AE, Objective Response Rate (ORR) per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 as assessed by Blinded Independent Central Review (BICR)

Detailed description

Duration of Response (DOR) per RECIST 1.1 as assessed by BICR, Progression Free Survival (PFS) per RECIST 1.1 as assessed by BICR, Overall Survival (OS), Area Under the Concentration-Time Curve (AUC) for MK-1084, Maximum Concentration (Cmax) of MK-1084, Trough Concentration (Ctrough) of MK-1084

Interventions

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion.

DRUGCARBOPLATIN

DRUGPEMETREXED

DRUGMK-1084

DRUGCETUXIMAB

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Percentage of Participants with a Dose Limiting Toxicity (DLT), Percentage of Participants who Experience at Least One Adverse Event (AE), Percentage of Participants who Discontinue Study Intervention Due to an AE, Objective Response Rate (ORR) per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 as assessed by Blinded Independent Central Review (BICR)	—

Secondary

Measure	Time frame
Duration of Response (DOR) per RECIST 1.1 as assessed by BICR, Progression Free Survival (PFS) per RECIST 1.1 as assessed by BICR, Overall Survival (OS), Area Under the Concentration-Time Curve (AUC) for MK-1084, Maximum Concentration (Cmax) of MK-1084, Trough Concentration (Ctrough) of MK-1084	—

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 26, 2026