KEYMAKER-U01 Substudy 01E: A Phase 2 Umbrella Study With Rolling Arms of Investigational Agents With or Without Chemotherapy in Combination With Pembrolizumab in Treatment of Participants With Newly Diagnosed Resectable Stages II-IIIB (N2) Non-small Cell Lung Cancer (NSCLC)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-509234-19-00

Acronym

MK-3475-01E

Enrollment

Registered

2024-09-16

Start date

2025-03-03

Completion date

Unknown

Last updated

2025-10-28

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

Conditions

Participants With Newly Diagnosed Resectable Stages II-IIIB (N2) Non-small Cell Lung Cancer (NSCLC)

Brief summary

Pathological Complete Response (pCR), Percent Residual Viable Tumor (%RVT)

Detailed description

Percentage of Participants Who Report at Least 1 Adverse Event (AE), Percentage of Participants Who Discontinue Study Treatment Due to an AE, Event-free Survival (EFS), Overall Survival (OS), Distant Metastasis-Free Survival (DMFS), Objective Response Rate (ORR), Percentage of Participants Who Experience a Perioperative Complication, Mean Length of Length of Hospital Stay, Percentage of Participants Who Require Hospital Readmission after Discharge, Mean Length of Surgery, Percentage of Participants Who Require a Blood Transfusion

Interventions

DRUGCARBOPLATIN

DRUGPEMETREXED

DRUGPACLITAXEL

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

DRUG-

DRUGMK-2870

DRUGFAMOTIDINE

DRUGCISPLATIN

DRUGGEMCITABINE

DRUGPARACETAMOL

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Pathological Complete Response (pCR), Percent Residual Viable Tumor (%RVT)	—

Secondary

Measure	Time frame
Percentage of Participants Who Report at Least 1 Adverse Event (AE), Percentage of Participants Who Discontinue Study Treatment Due to an AE, Event-free Survival (EFS), Overall Survival (OS), Distant Metastasis-Free Survival (DMFS), Objective Response Rate (ORR), Percentage of Participants Who Experience a Perioperative Complication, Mean Length of Length of Hospital Stay, Percentage of Participants Who Require Hospital Readmission after Discharge, Mean Length of Surgery, Percentage of Participants Who Require a Blood Transfusion	—

Measure

Time frame

—

Countries

Germany, Greece, Hungary, Italy, Poland, Spain

Outcome results

None listed

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