CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,177 enrolled
Drug / intervention
Pembrolizumab +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT02504372
NCT02504372Phase 3Completed
CompareCT.gov

A Randomized, Phase 3 Trial With Anti-PD-1 Monoclonal Antibody Pembrolizumab (MK-3475) Versus Placebo for Patients With Early Stage NSCLC After Resection and Completion of Standard Adjuvant Therapy (PEARLS)

Merck Sharp & Dohme LLC·interventional·Posted Jul 21, 2015·Updated Mar 17, 2026

In Brief

A Phase 3 clinical trial evaluating Pembrolizumab and Placebo for Non-small Cell Lung Cancer. Completed, enrolled 1,177 participants.

Detailed Summary

In this study, participants with Stage IB/II-IIIA non-small cell lung cancer (NSCLC) who have undergone surgical resection (lobectomy or pneumonectomy) with or without adjuvant chemotherapy will be treated with pembrolizumab or placebo. The primary study hypothesis is that pembrolizumab will provide improved disease-free survival (DFS) versus placebo.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-small Cell Lung Cancer
Countries--
CollaboratorsETOP, European Organisation for Research and Treatment of Cancer - EORTC

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 21, 2015
Enrollment StartNov 6, 2015
Primary CompletionJan 24, 2023
Study CompletionJan 21, 2026
TodayJul 2, 2026
Enrollment to primary: 7.2 yearsPosted 10.9 years ago

Interventions

Pembrolizumabbiological

IV infusion

Placeboother

IV infusion