NCT04624204

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)

Active, enrolled Phase 3 Last updated 2 July 2025

What this trial tests

Phase 3 trial testing Pembrolizumab 200 mg in Small Cell Lung Cancer in 672 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

8 December 2020

Primary endpoint
28 October 2027

28 October 2027

Quick facts

Lead sponsor	Merck Sharp & Dohme LLC
Phase	Phase 3
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	672
Start date	8 December 2020
Primary completion	28 October 2027
Estimated completion	28 October 2027
Sites	187 locations across Italy, Japan, South Korea, Russia, Belgium, Estonia, Mexico, Lithuania

Drugs / interventions tested

• Pembrolizumab 200 mg
• Pembrolizumab 400 mg — full drug profile →
• Pembrolizumab placebo (saline) — full drug profile →
• Pembrolizumab placebo (saline) — full drug profile →
• Olaparib 300 mg BID — full drug profile →
• Olaparib matching placebo — full drug profile →
• Etoposide 100 mg/m^2 — full drug profile →
• Platinum, investigator's choice
• Standard Thoracic Radiotherapy
• Prophylactic Cranial Irradiation (PCI)

Conditions studied

• Small Cell Lung Cancer — all drugs for Small Cell Lung Cancer →

Sponsor

Merck Sharp & Dohme LLC — full company profile →

Who can join

18 and older, any sex, with Small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Radiation and Systemic Therapy for Limited-Stage Small-Cell Lung Cancer.
   Bogart JA, Waqar SN, Mix MD. · · 2022 · cited 88× · PMID 34985935 · DOI 10.1200/jco.21.01639
2. The potential of PARP inhibitors in targeted cancer therapy and immunotherapy.
   Hunia J, Gawalski K, Szredzka A, Suskiewicz MJ, et al · · 2022 · cited 25× · PMID 36533080 · DOI 10.3389/fmolb.2022.1073797
3. SCLC Treatment in the Immuno-Oncology Era: Current Evidence and Unmet Needs.
   Belluomini L, Calvetti L, Inno A, Pasello G, et al · · 2022 · cited 24× · PMID 35494084 · DOI 10.3389/fonc.2022.840783
4. SEOM-GECP Clinical guidelines for diagnosis, treatment and follow-up of small-cell lung cancer (SCLC) (2022).
   García-Campelo R, Sullivan I, Arriola E, Insa A, et al · · 2023 · cited 20× · PMID 37418123 · DOI 10.1007/s12094-023-03216-3
5. P53 and Rb Aberrations in Small Cell Lung Cancer (SCLC): From Molecular Mechanisms to Therapeutic Modulation.
   Papavassiliou KA, Sofianidi AA, Gogou VA, Anagnostopoulos N, et al · · 2024 · cited 19× · PMID 38473726 · DOI 10.3390/ijms25052479
6. Current and future therapies for small cell lung carcinoma.
   Zhai X, Zhang Z, Chen Y, Wu Y, et al · · 2025 · cited 15× · PMID 40170056 · DOI 10.1186/s13045-025-01690-6
7. Current status and future perspectives of immune checkpoint inhibitors in extensive-stage small cell lung cancer.
   Liu X, Xing H, Liu B. · · 2022 · cited 15× · PMID 35812062
8. Immune Checkpoint Inhibitors and Chemoradiation for Limited-Stage Small Cell Lung Cancer.
   Schlick B, Shields MD, Marin-Acevedo JA, Patel I, et al · · 2022 · cited 12× · PMID 35716328 · DOI 10.1007/s11864-022-00989-7