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) KEYNOTE-091

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-509137-39-00

Acronym

MK-3475-091

Enrollment

430

Registered

2024-07-02

Start date

2015-11-06

Completion date

Unknown

Last updated

2025-11-12

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

Conditions

II and IIIA NSCLC, Stage IB (T ≥ 4 cm)

Brief summary

♦ DFS in the PD-L1 strong positive subgroup;, ♦ DFS in the overall population.

Detailed description

♦ DFS in the PD-L1 positive population;, ♦ OS in the overall population;, ♦ OS in the PD-L1 strong positive subgroup;, ♦ OS in the PD-L1 positive population;, ♦ LCSS in the overall population;, ♦ Toxicity according to CTCAE version 4.03.

Interventions

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

DRUGSodium chloride

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
♦ DFS in the PD-L1 strong positive subgroup;, ♦ DFS in the overall population.	—

Secondary

Measure	Time frame
♦ DFS in the PD-L1 positive population;, ♦ OS in the overall population;, ♦ OS in the PD-L1 strong positive subgroup;, ♦ OS in the PD-L1 positive population;, ♦ LCSS in the overall population;, ♦ Toxicity according to CTCAE version 4.03.	—

Countries

Austria, Belgium, Czechia, Denmark, Estonia, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Netherlands, Poland, Portugal, Slovenia, Spain

Outcome results

None listed

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