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Placebo-controlled, Study of Concurrent Chemoradiation Therapy With Pembrolizumab Followed by Pembrolizumab and Olaparib in Newly Diagnosed Treatment-Naïve Limited-Stage Small Cell Lung Cancer (LS-SCLC) (MK 7339-013/KEYLYNK-013)

NCT04624204 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 672

Last updated 2025-07-02

No results posted yet for this study

Summary

Researchers are looking for new ways to treat Limited-Stage Small Cell Lung Cancer (LS-SCLC), a type of lung cancer that has not spread from the lung to other parts of the body. The purpose of this study is to learn if pembrolizumab and olaparib, when given with chemotherapy and radiation treatment (CRT), can be effective in treating LS-SCLC. The researchers want to know if participants who receive CRT and pembrolizumab, with or without olaparib, have a longer overall survival compared to participants who only receive CRT.

Conditions

Interventions

BIOLOGICAL

Pembrolizumab 200 mg

Pembrolizumab 200 mg Q3W

BIOLOGICAL

Pembrolizumab 400 mg

Pembrolizumab 400 mg Q6W

DRUG

Pembrolizumab placebo (saline)

Pembrolizumab placebo (saline) Q3W

DRUG

Pembrolizumab placebo (saline)

Pembrolizumab placebo (saline) Q6W

DRUG

Olaparib 300 mg BID

Olaparib 300 mg twice daily (BID)

DRUG

Olaparib matching placebo

Olaparib matching placebo BID

DRUG

Etoposide 100 mg/m^2

Etoposide 100 mg/m\^2 intravenous (IV) Q3W, Day 1-3

DRUG

Platinum, investigator's choice

Carboplatin titrated to an area under the plasma drug concentration time curve (AUC) of 5 mg/mL/min IV Q3W OR Cisplatin 75 mg/m\^2 IV Q3W on Day 1 of each cycle

RADIATION

Standard Thoracic Radiotherapy

Standard Thoracic Radiotherapy

RADIATION

Prophylactic Cranial Irradiation (PCI)

PCI will be strongly recommended for participants who achieve CR or PR after completion of chemoradiation treatment.

Sponsors & Collaborators

Principal Investigators

  • Medical Director, MD · 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
2020-12-08
Primary Completion
2027-10-28
Completion
2027-10-28
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Bulgaria
  • Canada
  • China
  • Estonia
  • France
  • Greece
  • Hungary
  • Israel
  • Italy
  • Japan
  • Lithuania
  • Mexico
  • Portugal
  • Romania
  • Russia
  • Serbia
  • South Africa
  • South Korea
  • Spain
  • Turkey (Türkiye)
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

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 NCT04624204 on ClinicalTrials.gov