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Protocol Title: KEYMAKER-U01 Substudy 01F: A Phase 1b/2 Umbrella Study With Rolling Arms of Investigational Agents for Previously Treated of Participants With Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With KRAS G12C Mutations

Status
Not yet recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-512248-47-00
Enrollment
32
Registered
2026-03-04
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-05

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 (NSCLC)

Brief summary

Number of Participants Who Experience a Dose Limiting Toxicity (DLT), Number of Participants Who Experience an Adverse Event (AE), Number of Participants Who Discontinue Study Treatment Due to an AE, Objective Response Rate (ORR)

Detailed description

Duration of Response (DOR), Progression-Free Survival (PFS), Area Under the Curve From Time 0 to the End of the Dosing Interval (AUC tau), Maximum Plasma Concentration (Cmax), Minimum Observed Concentration (Ctrough)

Interventions

DRUG-
DRUGCETUXIMAB

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Number of Participants Who Experience a Dose Limiting Toxicity (DLT), Number of Participants Who Experience an Adverse Event (AE), Number of Participants Who Discontinue Study Treatment Due to an AE, Objective Response Rate (ORR)

Secondary

MeasureTime frame
Duration of Response (DOR), Progression-Free Survival (PFS), Area Under the Curve From Time 0 to the End of the Dosing Interval (AUC tau), Maximum Plasma Concentration (Cmax), Minimum Observed Concentration (Ctrough)

Outcome results

None listed

Source: EU CTIS · Data processed: Mar 6, 2026