CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 797 enrolled
Drug / intervention
Pembrolizumab +4 morebiological
Likely dose
Pembrolizumab 200 mg IV Q3W (on cycle day 1) combined with cisplatin 75 mg/m² IV Q3W (day 1) + gemcitabine 1000 mg/m² IV Q3W (days 1 and 8) for squamous NSCLC or cisplatin 75 mg/m² IV Q3W (day 1) + pemetrexed 500 mg/m² IV Q3W (day 1) for nonsquamous NSCLCAI-extracted
Key inclusion· 4
  • ✓Pathologically confirmed resectable stage II, IIIA, or IIIB (N2) NSCLC that is previously untreated
  • ✓ECOG performance status 0 to 1 within 10 days of randomization
  • ✓Adequate organ function
  • ✓Available tumor tissue (FFPE blocks or unstained slides) for PD-L1 testing
Key exclusion· 10
  • ✕NSCLC involving the superior sulcus, large cell neuro-endocrine cancer (LCNEC), or sarcomatoid tumor
  • ✕History of (non-infectious) pneumonitis/interstitial lung disease requiring steroids or current pneumonitis/ILD requiring steroids
  • ✕Active infection requiring systemic therapy
  • ✕Prior anti-PD-1, anti-PD-L1, anti-PD-L2, or co-inhibitory T-cell receptor-directed therapy

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03425643
NCT03425643Phase 3Active
CompareCT.gov

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)

Merck Sharp & Dohme LLC·interventional·Posted Feb 7, 2018·Updated Dec 3, 2024

In Brief

A Phase 3 clinical trial evaluating Pembrolizumab, Placebo, and 3 other interventions for Non-small Cell Lung Cancer. Active but no longer recruiting, targeting 797 participants across 227 sites in 25 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-small Cell Lung Cancer
CountriesArgentina, 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, United States
Collaborators--

Timeline

Phase 3ActiveOverdue
201820192020202120222023202420252026
First PostedFeb 7, 2018
Enrollment StartApr 24, 2018
Primary CompletionJul 10, 2023
Study CompletionJun 29, 2026
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 8.4 years ago

Interventions

Pembrolizumabbiological

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

Placebodrug

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

Cisplatindrug

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

Gemcitabinedrug

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

Pemetrexeddrug

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