A Phase III, Randomized, Double-blind Trial of Platinum Doublet Chemotherapy +/- Pembrolizumab (MK-3475) as Neoadjuvant/Adjuvant Therapy for Participants with Resectable Stage II, IIIA, and Resectable IIIB (T3-4N2) Non-small Cell Lung Cancer (NSCLC) (KEYNOTE-671)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-504820-24-00

Acronym

MK-3475-671

Enrollment

275

Registered

2023-10-06

Start date

2018-03-21

Completion date

Unknown

Last updated

2025-08-22

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

Conditions

Neoadjuvant/Adjuvant treatment for participants with Resectable Stage II or IIIA-B (N2) NSCLC

Brief summary

Event Free Survival (EFS), Overall Survival (OS)

Detailed description

Major Pathological Response (mPR) Rate, Pathological Complete Response (pCR) Rate, Global Health Status/Quality of Life (GHS/QoL) Score using the European Organization for Research and Treatment (EORTC) QoL Questionnaire (QLQ-C30), Adverse Events (AEs), Perioperative Complications, Treatment Discontinuations Due to AEs

Interventions

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

DRUGGEMCITABINE

DRUGPlacebo (Normal saline)

DRUGCISPLATIN

DRUGPEMETREXED

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Event Free Survival (EFS), Overall Survival (OS)	—

Secondary

Measure	Time frame
Major Pathological Response (mPR) Rate, Pathological Complete Response (pCR) Rate, Global Health Status/Quality of Life (GHS/QoL) Score using the European Organization for Research and Treatment (EORTC) QoL Questionnaire (QLQ-C30), Adverse Events (AEs), Perioperative Complications, Treatment Discontinuations Due to AEs	—

Countries

Belgium, Estonia, France, Germany, Ireland, Italy, Latvia, Lithuania, Poland, Romania, Spain

Outcome results

None listed

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