Active, not recruiting
Phase 3
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)
Condition(s) studied
Small Cell Lung Cancer
Investigational drug(s) / intervention(s)
Pembrolizumab 200 mgPembrolizumab 400 mgPembrolizumab placebo (saline)Pembrolizumab placebo (saline)Olaparib 300 mg BIDOlaparib matching placeboEtoposide 100 mg/m^2Platinum, investigator's choiceStandard Thoracic RadiotherapyProphylactic Cranial Irradiation (PCI)
Pembrolizumab 200 mg: Pembrolizumab 200 mg Q3W
Pembrolizumab 400 mg: Pembrolizumab 400 mg Q6W
Pembrolizumab placebo (saline): Pembrolizumab placebo (saline) Q3W
Pembrolizumab placebo (saline): Pembrolizumab placebo (saline) Q6W
Olaparib 300 mg BID: Olaparib 300 mg twice daily (BID)
Olaparib matching placebo: Olaparib matching placebo BID
Etoposide 100 mg/m^2: Etoposide 100 mg/m\^2 intravenous (IV) Q3W, Day 1-3
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
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.
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