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)

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Small Cell Lung Cancer

In brief

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.

Key facts

Study ID: NCT04624204
Run by: Merck Sharp & Dohme LLC
People needed: 672
Starts: 2020-12-08
Expected to finish: 2027-10-28
Last updated by the study team: 2026-05-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Has pathologically (histologically or cytologically) confirmed Small Cell Lung Cancer (SCLC).
Note: Note: Participants with histology showing a mixed tumor with small cell and non-small cell elements are not eligible.
Has Limited-Stage SCLC (Stage I-III, by AJCC 8th Edition Cancer Staging), and can be safely treated with definitive radiation doses.
Has no evidence of metastatic disease by whole body positron emission tomography /computed tomography (PET/CT scan), CT or magnetic resonance imaging (MRI) scans
Has at least 1 lesion that meets the criteria for being measurable, as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
Has not received prior treatment (chemotherapy or radiotherapy or surgery resection) of LS-SCLC.
Is not expected to require tumor resection during the course of the study.
Must submit a pre-treatment tumor tissue sample (formalin-fixed, paraffin embedded blocks are preferred to slides) including cytologic sample, if tissue sample unavailable.
Has Eastern Cooperative Oncology Group (ECOG) Performance score 0 or 1 assessed within 7 days prior to the first administration of study intervention.
Has a life expectancy of at least 6 months.
Has adequate organ function.
Male and female participants who are not pregnant and of childbearing potential must follow contraceptive guidance during the treatment period and for the time needed to eliminate each study intervention.
Male and female participants who are at least 18 years of age at the time of signing the information consent.
Male participants must refrain from donating sperm during the treatment period and for the time needed to eliminate each study intervention.
Abstains from breastfeeding during the study intervention period and for at least the following period after the last study intervention:
Pembrolizumab: 120 days
Olaparib: 30 days

You may not qualify if…

Has history, current diagnosis, or features suggestive of myelodysplastic syndrome/ acute myeloid leukemia (MDS/AML).
Has received prior therapy with an anti-programmed cell death 1 (anti-PD-1), anti-programmed cell death ligand 1 (anti-PDL1), or anti- programmed cell death ligand 2 (anti-PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor
Has received prior therapy with olaparib or with any other polyadenosine 5'diphosphoribose (polyADP ribose) polymerization (PARP) inhibitor.
Had major surgery <4 weeks prior to the first dose of study intervention (except for placement of vascular access).
Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study intervention.
Has a known additional malignancy that is progressing or has required active treatment within the past 5 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.
Has severe hypersensitivity (≥ Grade 3) to study intervention and/or any of its excipients.
Has an active autoimmune disease that has required systemic treatment in past 2 years
Has a history of (non-infectious) pneumonitis/interstitial lung disease that requires steroids
Has an active infection requiring systemic therapy.
Has a known history of human immunodeficiency virus (HIV) infection or Hepatitis B or known active Hepatitis C virus infection.

Where it is running

Loma Linda University Cancer Center ( Site 0011) — Loma Linda, California, United States
Georgetown University ( Site 0017) — Washington D.C., District of Columbia, United States
Moffitt Cancer Center ( Site 0137) — Tampa, Florida, United States
University of Chicago Medical Center ( Site 0136) — Chicago, Illinois, United States
Fort Wayne Medical Oncology and Hematology ( Site 0034) — Fort Wayne, Indiana, United States
University of Kentucky Chandler Medical Center ( Site 0138) — Lexington, Kentucky, United States
Overton Brooks VAMC ( Site 0041) — Shreveport, Louisiana, United States
Harry & Jeanette Weinberg Cancer Institute ( Site 0045) — Baltimore, Maryland, United States
VA Ann Arbor Healthcare System ( Site 0050) — Ann Arbor, Michigan, United States
St. Vincent Healthcare Frontier Cancer Center ( Site 0056) — Billings, Montana, United States
Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0061) — Omaha, Nebraska, United States
Memorial Sloan Kettering - Basking Ridge ( Site 0133) — Basking Ridge, New Jersey, United States
John Theurer Cancer Center ( Site 0064) — Hackensack, New Jersey, United States
Memorial Sloan Kettering - Monmouth ( Site 0135) — Middletown, New Jersey, United States
Memorial Sloan Kettering - Bergen ( Site 0130) — Montvale, New Jersey, United States
Rutgers Cancer Institute of New Jersey ( Site 0123) — New Brunswick, New Jersey, United States
Memorial Sloan Kettering- Commack ( Site 0132) — Commack, New York, United States
Memorial Sloan Kettering - Westchester-Thoracic Oncology ( Site 0134) — Harrison, New York, United States
Memorial Sloan Kettering Cancer Center ( Site 0069) — New York, New York, United States
Memorial Sloan Kettering - Nassau ( Site 0131) — Uniondale, New York, United States
Fairview Hospital-Moll Cancer Center ( Site 0141) — Cleveland, Ohio, United States
Cleveland Clinic Main ( Site 0139) — Cleveland, Ohio, United States
Cleveland Clinic - Hillcrest Hospital-Hillcrest Hospital Cancer Center ( Site 0140) — Mayfield Heights, Ohio, United States
Penn State Hershey Cancer Institute ( Site 0081) — Hershey, Pennsylvania, United States
Ironwood Cancer & Research Centers ( Site 0007) — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

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