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Efficacy and Safety of Pembrolizumab (MK-3475) With Platinum Doublet Chemotherapy as Neoadjuvant/Adjuvant Therapy for Participants With Resectable Stage II, IIIA, and Resectable IIIB (T3-4N2) Non-small Cell Lung Cancer (MK-3475-671/KEYNOTE-671)

NCT03425643 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 797

Last updated 2024-12-03

Study results available
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Summary

This trial will evaluate the safety and efficacy of pembrolizumab (MK-3475) in combination with platinum doublet neoadjuvant chemotherapy (NAC) before surgery \[neoadjuvant phase\], followed by pembrolizumab alone after surgery \[adjuvant phase\] in participants with resectable stage II, IIIA, and resectable IIIB (T3-4N2) non-small cell lung cancer (NSCLC). The primary hypotheses of this study are that neoadjuvant pembrolizumab (vs. placebo) in combination with NAC, followed by surgery and adjuvant pembrolizumab (vs. placebo) will improve: 1) event free survival (EFS) by biopsy assessed by local pathologist or by investigator-assessed imaging using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1); and 2) overall survival (OS).

Conditions

Interventions

BIOLOGICAL

Pembrolizumab

200 mg by IV infusion every 3 weeks (Q3W), given on cycle day 1.

DRUG

Placebo

Normal saline by IV infusion Q3W, given on cycle day 1.

DRUG

Cisplatin

75 mg/m\^2 by IV infusion Q3W, given on cycle day 1.

DRUG

Gemcitabine

1000 mg/m\^2 by IV infusion Q3W, given on cycle days 1 and 8. Given only to participants with squamous NSCLC.

DRUG

Pemetrexed

500 mg/m\^2 by IV infusion Q3W, given on cycle day 1. Given only to participants with nonsquamous NSCLC.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-24
Primary Completion
2023-07-10
Completion
2026-06-29
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Canada
  • China
  • Estonia
  • France
  • Germany
  • Ireland
  • Italy
  • Japan
  • Latvia
  • Lithuania
  • Malaysia
  • Poland
  • Romania
  • Russia
  • South Africa
  • South Korea
  • Spain
  • Taiwan
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03425643 on ClinicalTrials.gov