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Study of Pembrolizumab With Concurrent Chemoradiation Therapy Followed by Pembrolizumab With or Without Olaparib in Stage III Non-Small Cell Lung Cancer (NSCLC) (MK-7339-012/KEYLYNK-012)

NCT04380636 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 870

Last updated 2026-05-15

No results posted yet for this study

Summary

The purpose of this study is to assess the efficacy and safety of pembrolizumab in combination with concurrent chemoradiation therapy followed by either pembrolizumab with olaparib placebo (Arm 1) or with olaparib (Arm 2) compared to concurrent chemoradiation therapy followed by durvalumab (Arm 3) in participants with unresectable, locally advanced NSCLC. Arms 1 and 2 will be studied in a double-blind design and Arm 3 will be open-label. The primary hypotheses are:

1. Pembrolizumab with concurrent chemoradiation therapy followed by pembrolizumab with olaparib is superior to concurrent chemoradiation therapy followed by durvalumab with respect to progression-free survival (PFS) and overall survival (OS)
2. Pembrolizumab with concurrent chemoradiation therapy followed by pembrolizumab is superior to concurrent chemoradiation therapy followed by durvalumab with respect to PFS and OS

Conditions

  • Lung Neoplasms
  • Carcinoma, Non-Small-Cell Lung

Interventions

BIOLOGICAL

Pembrolizumab

intravenous (IV) infusion

DRUG

Olaparib

oral tablets

DRUG

Placebo for olaparib

oral tablets

DRUG

Etoposide

IV infusion

DRUG

Carboplatin

IV infusion

DRUG

Cisplatin

IV infusion

DRUG

Paclitaxel

IV infusion

DRUG

Pemetrexed

IV infusion

RADIATION

Thoracic Radiotherapy

external beam radiation

DRUG

Durvalumab

IV infusion

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-06
Primary Completion
2027-05-05
Completion
2029-07-06
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Canada
  • Chile
  • China
  • Czechia
  • Estonia
  • France
  • Germany
  • Hungary
  • Italy
  • Japan
  • Latvia
  • Lithuania
  • Mexico
  • Norway
  • Peru
  • Poland
  • Romania
  • Russia
  • South Korea
  • Spain
  • Thailand
  • Turkey (Türkiye)
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
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 NCT04380636 on ClinicalTrials.gov