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)
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
Standard Thoracic Radiotherapy: Standard Thoracic Radiotherapy
Prophylactic Cranial Irradiation (PCI): PCI will be strongly recommended for participants who achieve CR or PR after completion of chemoradiation treatment.
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. 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.
2. Has Limited-Stage SCLC (Stage I-III, by AJCC 8th Edition Cancer Staging), and can be safely treated with definitive radiation doses.
3. Has no evidence of metastatic disease by whole body positron emission tomography /computed tomography (PET/CT scan), CT or magnetic resonance imaging (MRI) scans
4. 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)
5. Has not received prior treatment (chemotherapy or radiotherapy or surgery resection) of LS-SCLC.
6. Is not expected to require tumor resection during the course of the study.
7. Must submit a pre-treatment tumor tissue sample (formalin-fixed, paraffin embedded blocks are preferred to slides) including cytologic sample, if tissue sample unavailable.
8. Has Eastern Cooperative Oncology Group (ECOG) Performance score 0 or 1 assessed within 7 days prior to the first administration of study intervention.
9. Has a life expectancy of at least 6 months.
10. Has adequate organ function.
11. 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.
12. Male and female participants who are at least 18 years of age at the time of signing the information consent.
13. Male participants must refrain from donating sperm during the treatment period and for the time needed to eliminate each study intervention.
14. 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
Exclusion Criteria:
1. Has history, current diagnosis, or features suggestive of myelodysplastic syndrome/ acute myeloid leukemia (MDS/AML).
2. 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
3. Has received prior therapy with olaparib or with any other polyadenosine 5'diphosphoribose (polyADP ribose) polymerization (PARP) inhibitor.
4. Had major surgery \<4 weeks prior to the first dose of study intervention (except for placement of vascular access).
5. 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.
6. 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.
7. 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.
8. Has severe hypersensitivity (≥ Grade 3) to study intervention and/or any of its excipients.
9. Has an active autoimmune disease that has required systemic treatment in past 2 years
10. Has a history of (non-infectious) pneumonitis/interstitial lung disease that requires steroids
11. Has an active infection requiring systemic therapy.
12. Has a known history of human immunodeficiency virus (HIV) infection or Hepatitis B or known active Hepatitis C virus infection.
Primary outcome measure(s)
Overall Survival: the time from randomization to death due to any cause — Up to approximately 82 months Overall Survival (OS) is the time from randomization to death due to any cause.
Trial sites (187)
Facility
City
Region
Status
Ironwood Cancer & Research Centers ( Site 0007)
Chandler
Arizona
Loma Linda University Cancer Center ( Site 0011)
Loma Linda
California
Georgetown University ( Site 0017)
Washington D.C.
District of Columbia
Moffitt Cancer Center ( Site 0137)
Tampa
Florida
University of Chicago Medical Center ( Site 0136)
Chicago
Illinois
Fort Wayne Medical Oncology and Hematology ( Site 0034)
Fort Wayne
Indiana
University of Kentucky Chandler Medical Center ( Site 0138)
Lexington
Kentucky
Overton Brooks VAMC ( Site 0041)
Shreveport
Louisiana
Harry & Jeanette Weinberg Cancer Institute ( Site 0045)
Baltimore
Maryland
VA Ann Arbor Healthcare System ( Site 0050)
Ann Arbor
Michigan
St. Vincent Healthcare Frontier Cancer Center ( Site 0056)
Billings
Montana
Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0061)
Omaha
Nebraska
Memorial Sloan Kettering - Basking Ridge ( Site 0133)
Basking Ridge
New Jersey
John Theurer Cancer Center ( Site 0064)
Hackensack
New Jersey
Memorial Sloan Kettering - Monmouth ( Site 0135)
Middletown
New Jersey
Memorial Sloan Kettering - Bergen ( Site 0130)
Montvale
New Jersey
Rutgers Cancer Institute of New Jersey ( Site 0123)
New Brunswick
New Jersey
Memorial Sloan Kettering- Commack ( Site 0132)
Commack
New York
Memorial Sloan Kettering - Westchester-Thoracic Oncology ( Site 0134)
Harrison
New York
Memorial Sloan Kettering Cancer Center ( Site 0069)
New York
New York
Memorial Sloan Kettering - Nassau ( Site 0131)
Uniondale
New York
Fairview Hospital-Moll Cancer Center ( Site 0141)
Cleveland
Ohio
Cleveland Clinic Main ( Site 0139)
Cleveland
Ohio
Cleveland Clinic - Hillcrest Hospital-Hillcrest Hospital Cancer Center ( Site 0140)
Mayfield Heights
Ohio
Penn State Hershey Cancer Institute ( Site 0081)
Hershey
Pennsylvania
Saint Francis Cancer Center ( Site 0087)
Greenville
South Carolina
The University of Tennessee Medical Center ( Site 0116)
Knoxville
Tennessee
Texas Oncology - Dallas (Presbyterian)_McIntyre ( Site 0098)
Dallas
Texas
Texas Oncology - Dallas (Sammons) ( Site 0093)
Dallas
Texas
MD Anderson Cancer Center ( Site 0100)
Houston
Texas
Millennium Research & Clinical Development ( Site 0143)
Houston
Texas
Providence Regional Cancer Partnership ( Site 0106)
Everett
Washington
Medical Oncology Associates, PS ( Site 0142)
Spokane
Washington
Multicare Institute For Research And Innovation ( Site 0108)
Tacoma
Washington
Virginia Mason Memorial- North Star Lodge Cancer Center ( Site 0112)
Yakima
Washington
Campbelltown Hospital ( Site 3002)
Campbelltown
New South Wales
Nepean Hospital ( Site 3001)
Kingswood
New South Wales
Calvary Mater Newcastle ( Site 3000)
Waratah
New South Wales
Gold Coast University Hospital ( Site 3003)
Southport
Queensland
Frankston Hospital-Oncology and Haematology ( Site 3007)
Frankston
Victoria
+ 147 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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