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 | Active Not Recruiting Phase 3 DMC FDA Drug

• 6 other identifiers: 7339-013MK-7339-013jRCT20312002962023-504959-27-00U1111-1290-48702019-003616-31
• Study Type: interventional
• Target: 672
• Locations: 24 countries
• Sites: 185

Brief 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

Small Cell Lung Cancer

Keywords

Programmed Cell Death-1 (PD1, PD-1); Programmed Death-Ligand 1 (PDL1, PD-L1); Pembrolizumab; Olaparib

Outcome Measures

Primary Outcomes (2)

• Progression-free Survival Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1); the time from randomization to progression or death due to any cause, whichever occurs first

  Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) is the time from randomization to progression or death due to any cause, whichever occurs first.

  Up to approximately 59 months

• Overall Survival: the time from randomization to death due to any cause

  Overall Survival (OS) is the time from randomization to death due to any cause.

  Up to approximately 82 months

Secondary Outcomes (18)

• Number of Participants Experiencing an Adverse Events (AEs)

  Up to approximately 82 months

• Number of Participants Discontinuing Study Treatment Due to Adverse Events (AEs)

  Up to approximately 82 months

• Objective Response (OR): Complete Response (CR) or Partial Response (PR)

  Up to approximately 82 months

• Duration of Response (DOR): the time from the earliest date of first documented evidence of confirmed CR or PR until the earliest date of disease progression or death from any cause, whichever comes first

  Up to approximately 82 months

• Change from Baseline at Cycle 1 in European Organization for Research and Treatment (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status / Quality of Life (Items 29 & 30) Scale Score

  Baseline and 82 months post randomization

Study Arms (3)

Group A - Pembrolizumab 200 mg

EXPERIMENTAL

Participants will receive 4 cycles of standard-of-care chemotherapy (etoposide/platinum) plus pembrolizumab 200 mg every 3 weeks (Q3W) concurrently with standard thoracic radiotherapy, followed by 9 cycles of pembrolizumab 400 mg every 6 weeks (Q6W) plus olaparib matching placebo twice daily (BID) for 12 months or until specific discontinuation criteria are met.

Biological: Pembrolizumab 200 mg; Biological: Pembrolizumab 400 mg; Drug: Olaparib matching placebo; Drug: Etoposide 100 mg/m^2; Drug: Platinum, investigator's choice; Radiation: Standard Thoracic Radiotherapy; Radiation: Prophylactic Cranial Irradiation (PCI)

Group B - Pembrolizumab 200 mg plus Olaparib 300 mg BID

EXPERIMENTAL

Participants will receive 4 cycles of standard-of-care chemotherapy (etoposide/platinum) plus pembrolizumab 200 mg Q3W concurrently with standard thoracic radiotherapy, followed by 9 cycles of pembrolizumab 400 mg Q6W plus olaparib 300 mg BID for 12 months or until specific discontinuation criteria are met.

Biological: Pembrolizumab 200 mg; Biological: Pembrolizumab 400 mg; Drug: Olaparib 300 mg BID; Drug: Etoposide 100 mg/m^2; Drug: Platinum, investigator's choice; Radiation: Standard Thoracic Radiotherapy; Radiation: Prophylactic Cranial Irradiation (PCI)

Group C (Pembrolizumab and Olaparib Matching Placebos)

PLACEBO COMPARATOR

Participants will receive 4 cycles of standard-of-care chemotherapy (etoposide/platinum) plus pembrolizumab placebo (saline) Q3W concurrently with standard thoracic radiotherapy, followed by 9 cycles of pembrolizumab placebo (saline) Q6W plus olaparib matching placebo for 12 months or until specific discontinuation criteria are met.

Drug: Pembrolizumab placebo (saline); Drug: Olaparib matching placebo; Drug: Etoposide 100 mg/m^2; Drug: Platinum, investigator's choice; Radiation: Standard Thoracic Radiotherapy; Radiation: Prophylactic Cranial Irradiation (PCI)

Interventions

Pembrolizumab 200 mg BIOLOGICAL

Pembrolizumab 200 mg Q3W

Also known as: MK-3475, KEYTRUDA®

Group A - Pembrolizumab 200 mg; Group B - Pembrolizumab 200 mg plus Olaparib 300 mg BID

Pembrolizumab 400 mg BIOLOGICAL

Pembrolizumab 400 mg Q6W

Also known as: MK-3475, KEYTRUDA®

Group A - Pembrolizumab 200 mg; Group B - Pembrolizumab 200 mg plus Olaparib 300 mg BID

Pembrolizumab placebo (saline) DRUG

Pembrolizumab placebo (saline) Q3W

Group C (Pembrolizumab and Olaparib Matching Placebos)

Olaparib 300 mg BID DRUG

Olaparib 300 mg twice daily (BID)

Also known as: MK-7339, LYNPARZA®

Group B - Pembrolizumab 200 mg plus Olaparib 300 mg BID

Olaparib matching placebo DRUG

Olaparib matching placebo BID

Group A - Pembrolizumab 200 mg; Group C (Pembrolizumab and Olaparib Matching Placebos)

Etoposide 100 mg/m^2 DRUG

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

Group A - Pembrolizumab 200 mg; Group B - Pembrolizumab 200 mg plus Olaparib 300 mg BID; Group C (Pembrolizumab and Olaparib Matching Placebos)

Platinum, investigator's choice DRUG

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

Group A - Pembrolizumab 200 mg; Group B - Pembrolizumab 200 mg plus Olaparib 300 mg BID; Group C (Pembrolizumab and Olaparib Matching Placebos)

Standard Thoracic Radiotherapy RADIATION

Standard Thoracic Radiotherapy

Group A - Pembrolizumab 200 mg; Group B - Pembrolizumab 200 mg plus Olaparib 300 mg BID; Group C (Pembrolizumab and Olaparib Matching Placebos)

Prophylactic Cranial Irradiation (PCI) RADIATION

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

Group A - Pembrolizumab 200 mg; Group B - Pembrolizumab 200 mg plus Olaparib 300 mg BID; Group C (Pembrolizumab and Olaparib Matching Placebos)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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:

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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (187)

Ironwood Cancer & Research Centers ( Site 0007)

Chandler, Arizona, 85224, United States

Location

Loma Linda University Cancer Center ( Site 0011)

Loma Linda, California, 92350, United States

Location

Georgetown University ( Site 0017)

Washington D.C., District of Columbia, 20007, United States

Location

Moffitt Cancer Center ( Site 0137)

Tampa, Florida, 33612, United States

Location

University of Chicago Medical Center ( Site 0136)

Chicago, Illinois, 60637, United States

Location

Fort Wayne Medical Oncology and Hematology ( Site 0034)

Fort Wayne, Indiana, 46804, United States

Location

University of Kentucky Chandler Medical Center ( Site 0138)

Lexington, Kentucky, 40536, United States

Location

Overton Brooks VAMC ( Site 0041)

Shreveport, Louisiana, 71101, United States

Location

Harry & Jeanette Weinberg Cancer Institute ( Site 0045)

Baltimore, Maryland, 21237, United States

Location

VA Ann Arbor Healthcare System ( Site 0050)

Ann Arbor, Michigan, 48105, United States

Location

St. Vincent Healthcare Frontier Cancer Center ( Site 0056)

Billings, Montana, 59102, United States

Location

Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0061)

Omaha, Nebraska, 68130, United States

Location

Memorial Sloan Kettering - Basking Ridge ( Site 0133)

Basking Ridge, New Jersey, 07920, United States

Location

John Theurer Cancer Center ( Site 0064)

Hackensack, New Jersey, 07601, United States

Location

Memorial Sloan Kettering - Monmouth ( Site 0135)

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering - Bergen ( Site 0130)

Montvale, New Jersey, 07645, United States

Location

Rutgers Cancer Institute of New Jersey ( Site 0123)

New Brunswick, New Jersey, 08901, United States

Location

Memorial Sloan Kettering- Commack ( Site 0132)

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering - Westchester-Thoracic Oncology ( Site 0134)

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center ( Site 0069)

New York, New York, 10021, United States

Location

Memorial Sloan Kettering - Nassau ( Site 0131)

Uniondale, New York, 11553, United States

Location

Fairview Hospital-Moll Cancer Center ( Site 0141)

Cleveland, Ohio, 44111, United States

Location

Cleveland Clinic Main ( Site 0139)

Cleveland, Ohio, 44195, United States

Location

Cleveland Clinic - Hillcrest Hospital-Hillcrest Hospital Cancer Center ( Site 0140)

Mayfield Heights, Ohio, 44124, United States

Location

Penn State Hershey Cancer Institute ( Site 0081)

Hershey, Pennsylvania, 17033, United States

Location

Saint Francis Cancer Center ( Site 0087)

Greenville, South Carolina, 29607, United States

Location

The University of Tennessee Medical Center ( Site 0116)

Knoxville, Tennessee, 37920, United States

Location

Texas Oncology - Dallas (Presbyterian)_McIntyre ( Site 0098)

Dallas, Texas, 75231, United States

Location

Texas Oncology - Dallas (Sammons) ( Site 0093)

Dallas, Texas, 75246, United States

Location

MD Anderson Cancer Center ( Site 0100)

Houston, Texas, 77030, United States

Location

Millennium Research & Clinical Development ( Site 0143)

Houston, Texas, 77090, United States

Location

Providence Regional Cancer Partnership ( Site 0106)

Everett, Washington, 98201, United States

Location

Medical Oncology Associates, PS ( Site 0142)

Spokane, Washington, 99208, United States

Location

Multicare Institute For Research And Innovation ( Site 0108)

Tacoma, Washington, 98405, United States

Location

Virginia Mason Memorial- North Star Lodge Cancer Center ( Site 0112)

Yakima, Washington, 98902, United States

Location

Campbelltown Hospital ( Site 3002)

Campbelltown, New South Wales, 2560, Australia

Location

Nepean Hospital ( Site 3001)

Kingswood, New South Wales, 2747, Australia

Location

Calvary Mater Newcastle ( Site 3000)

Waratah, New South Wales, 2298, Australia

Location

Gold Coast University Hospital ( Site 3003)

Southport, Queensland, 4215, Australia

Location

Frankston Hospital-Oncology and Haematology ( Site 3007)

Frankston, Victoria, 3199, Australia

Location

Austin Health-Austin Hospital ( Site 3006)

Heidelberg, Victoria, 3084, Australia

Location

Western Health-Sunshine Hospital ( Site 3004)

St Albans, Victoria, 3021, Australia

Location

Saint-Luc UCL ( Site 1005)

Brussels, Bruxelles-Capitale, Region de, 1200, Belgium

Location

Grand Hopital de Charleroi ( Site 1003)

Gilly, Hainaut, 6060, Belgium

Location

C.I.U. Hopital Ambroise Pare ( Site 1001)

Mons, Hainaut, 7000, Belgium

Location

CHU UCL Namur Site de Godinne ( Site 1004)

Yvoir, Namur, 5530, Belgium

Location

UZ Leuven ( Site 1002)

Leuven, Vlaams-Brabant, 3000, Belgium

Location

AZ Delta ( Site 1000)

Roeselare, West-Vlaanderen, 8800, Belgium

Location

MHAT "Uni Hospital" OOD ( Site 2507)

Panagyurishte, Pazardzhik, 4500, Bulgaria

Location

Cross Cancer Institute ( Site 0206)

Edmonton, Alberta, T6G 1Z2, Canada

Location

Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0212)

Hamilton, Ontario, L8V 5C2, Canada

Location

CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 0202)

Montreal, Quebec, H3T 1M5, Canada

Location

McGill University Health Centre ( Site 0210)

Montreal, Quebec, H4A 3J1, Canada

Location

CIUSSS de la Mauricie et du Centre du Quebec ( Site 0200)

Trois-Rivières, Quebec, G8Z 3R9, Canada

Location

Peking Union Medical College Hospital ( Site 3102)

Beijing, Beijing Municipality, 100006, China

Location

Cancer Hospital Chinese Academy of Medical Sciences ( Site 3104)

Beijing, Beijing Municipality, 100021, China

Location

Beijing Cancer hospital-Oncology Radiotherapy Department ( Site 3140)

Beijing, Beijing Municipality, 100142, China

Location

Beijing Cancer Hospital ( Site 3127)

Beijing, Beijing Municipality, 130021, China

Location

Chongqing Cancer Hospital ( Site 3135)

Chongqing, Chongqing Municipality, 400030, China

Location

Daping Hospital,Third Military Medical University ( Site 3136)

Chongqing, Chongqing Municipality, 400042, China

Location

Fujian Provincial Cancer Hospital ( Site 3126)

Fuzhou, Fujian, 350014, China

Location

The First Affiliated Hospital of Xiamen University ( Site 3121)

Xiamen, Fujian, 361003, China

Location

Peking University Shenzhen Hospital ( Site 3118)

Shenzhen, Guangdong, 518036, China

Location

Cancer Hospital Chinese Academy Of Medical Sciences. Shenzhen Center ( Site 3113)

Shenzhen, Guangdong, 518116, China

Location

Henan Cancer Hospital ( Site 3105)

Zhengzhou, Henan, 450008, China

Location

Tongji Medical College Huazhong University of Science and Technology ( Site 3138)

Wuhan, Hubei, 430030, China

Location

Union Hospital, Tongji Medical College of HUST ( Site 3123)

Wuhan, Hubei, 430048, China

Location

Hubei Cancer Hospital ( Site 3120)

Wuhan, Hubei, 430079, China

Location

Xiangya Hospital of Central South University ( Site 3137)

Changsha, Hunan, 410008, China

Location

Second Xiangya Hospital of Central-South University ( Site 3128)

Changsha, Hunan, 410011, China

Location

Hunan Cancer Hospital ( Site 3133)

Changsha, Hunan, 410013, China

Location

Jiangsu Cancer Hospital ( Site 3139)

Nanjing, Jiangsu, 210000, China

Location

The Second Affiliated Hospital of Nanchang University ( Site 3106)

Nanchang, Jiangxi, 330006, China

Location

The First Hospital of Jilin University ( Site 3132)

Changchun, Jilin, 130021, China

Location

Affiliated Cancer Hospital of Shandong First Medical University ( Site 3100)

Jinan, Shandong, 250117, China

Location

Shanghai Chest Hospital ( Site 3107)

Shanghai, Shanghai Municipality, 200030, China

Location

Shanghai Pulmonary Hospital ( Site 3101)

Shanghai, Shanghai Municipality, 200443, China

Location

West China Hospital of Sichuan University ( Site 3114)

Chengdu, Sichuan, 510115, China

Location

Tianjin Medical University Cancer Institute & Hospital ( Site 3103)

Tianjin, Tianjin Municipality, 300060, China

Location

Hangzhou Cancer Hospital ( Site 3129)

Hanghzou, Zhejiang, 310002, China

Location

The 1st Affil Hosp of College of Medicine, Zhejiang Univ ( Site 3131)

Hangzhou, Zhejiang, 310003, China

Location

Zhejiang Cancer Hospital ( Site 3108)

Hangzhou, Zhejiang, 310022, China

Location

SA Pohja-Eesti Regionaalhaigla ( Site 2201)

Tallinn, Harju, 13419, Estonia

Location

SA Tartu Ulikooli Kliinikum ( Site 2200)

Tartu, Tartu, 50406, Estonia

Location

C.H. de Saint Quentin ( Site 1111)

Saint-Quentin, Aisne, 02321, France

Location

CHU de Bordeaux Hop St ANDRE ( Site 1115)

Bordeaux, Aquitaine, 33075, France

Location

Clinique Clairval ( Site 1108)

Marseille, Bouches-du-Rhone, 13009, France

Location

CHU Grenoble -Hop Michallon ( Site 1102)

Grenoble, Isere, 38043, France

Location

Institut De Cancerologie De L Ouest ( Site 1110)

Saint-Herblain, Loire-Atlantique, 44805, France

Location

Institut de Cancerologie de l Ouest Site Paul Papin ( Site 1103)

Angers, Maine-et-Loire, 49000, France

Location

Hopital Avicenne ( Site 1106)

Bobigny, Seine-Saint-Denis, 93000, France

Location

H.I.A. Sainte-Anne ( Site 1101)

Toulon, Var, 83800, France

Location

Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 1105)

Paris, Île-de-France Region, 75014, France

Location

Henry Dunant Hospital ( Site 1205)

Athens, Attica, 115 26, Greece

Location

Sotiria Regional Chest Diseases Hospital of Athens ( Site 1200)

Athens, Attica, 115 27, Greece

Location

Anti-Cancer Hospital of Thessaloniki Theagenio ( Site 1204)

Thessaloniki, Central Macedonia, 54007, Greece

Location

University General Hospital of Herakleion ( Site 1202)

Heraklion, Irakleio, 711 10, Greece

Location

University General Hospital of Larisa ( Site 1201)

Larissa, Thessaly, 411 10, Greece

Location

Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 1306)

Kecskemét, Bács-Kiskun county, 6000, Hungary

Location

Petz Aladar Megyei Oktato Korhaz ( Site 1312)

Győr, Győr-Moson-Sopron, 9024, Hungary

Location

Reformatus Pulmonologiai Centrum ( Site 1304)

Törökbálint, Pest County, 2045, Hungary

Location

Orszagos Koranyi Pulmonologiai Intezet ( Site 1301)

Budapest, 1121, Hungary

Location

Orszagos Onkologiai Intezet ( Site 1310)

Budapest, 1122, Hungary

Location

Uzsoki Utcai Korhaz ( Site 1303)

Budapest, 1145, Hungary

Location

Rambam Health Care Campus-Oncology Division ( Site 1401)

Haifa, 3109601, Israel

Location

Chaim Sheba Medical Center ( Site 1400)

Ramat Gan, 5262000, Israel

Location

A O U Policlinico di Modena ( Site 1503)

Modena, Emilia-Romagna, 41125, Italy

Location

Azienda Ospedaliero Universitaria Careggi ( Site 1509)

Florence, Firenze, 50134, Italy

Location

Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento-Oncology Unit ( Site 1513)

Verona, Veneto, 37126, Italy

Location

Azienda Ospedaliera Spedali Civili di Brescia ( Site 1512)

Brescia, 25123, Italy

Location

IRCCS Ospedale San Raffaele ( Site 1500)

Milan, 20132, Italy

Location

Istituto Nazionale dei Tumori ( Site 1504)

Milan, 20133, Italy

Location

Istituto Europeo di Oncologia ( Site 1501)

Milan, 20141, Italy

Location

IRCCS Istituto Oncologico Veneto ( Site 1506)

Padua, 35128, Italy

Location

Policlinico Universitario Agostino Gemelli ( Site 1505)

Roma, 00168, Italy

Location

Aichi Cancer Center ( Site 4010)

Nagoya, Aichi-ken, 464-8681, Japan

Location

Kobe Minimally Invasive Cancer Center ( Site 4003)

Kobe, Hyōgo, 650-0046, Japan

Location

Takarazuka City Hospital ( Site 4013)

Takarazuka, Hyōgo, 665-0827, Japan

Location

Kanagawa Cancer Center ( Site 4001)

Yokohama, Kanagawa, 241-8515, Japan

Location

Kansai Medical University Hospital ( Site 4009)

Hirakata, Osaka, 573-1191, Japan

Location

Osaka Medical and Pharmaceutical University Hospital ( Site 4007)

Takatsuki, Osaka, 569-8686, Japan

Location

Shizuoka Cancer Center ( Site 4014)

Nakatogari, Shizuoka, 411-8777, Japan

Location

National Hospital Organization Kyushu Cancer Center ( Site 4000)

Fukuoka, 811-1395, Japan

Location

Niigata Cancer Center Hospital ( Site 4004)

Niigata, 951-8566, Japan

Location

Okayama University Hospital ( Site 4012)

Okayama, 700-8558, Japan

Location

Osaka International Cancer Institute ( Site 4005)

Osaka, 541-8567, Japan

Location

National Cancer Center Hospital ( Site 4015)

Tokyo, 104-0045, Japan

Location

Juntendo University Hospital ( Site 4008)

Tokyo, 113-0033, Japan

Location

Tokyo Metropolitan Komagome Hospital ( Site 4011)

Tokyo, 113-8677, Japan

Location

Cancer Institute Hospital of JFCR ( Site 4006)

Tokyo, 135-8550, Japan

Location

Showa Medical University Hospital ( Site 4002)

Tokyo, 142-8666, Japan

Location

Nacionalinis Vezio Institutas ( Site 2300)

Vilnius, Vilniaus Miestas, 08660, Lithuania

Location

LSMUL Kauno Klinikos ( Site 2301)

Kaunas, 50161, Lithuania

Location

Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0401)

Guadalajara, Jalisco, 44280, Mexico

Location

Hospital Universitario "Dr. Jose Eleuterio Gonzalez" ( Site 0404)

Monterrey, Nuevo León, 64460, Mexico

Location

Unidade Local de Saude de Santa Maria - Hospital Pulido Valente ( Site 1704)

Lisbon, Lisbon District, 1769-001, Portugal

Location

Inst. Portugues de Oncologia de Lisboa Francisco Gentil EPE ( Site 1705)

Lisbon, 1099-023, Portugal

Location

Instituto Portugues de Oncologia Do Porto Francisco Gentil E.P.E. ( Site 1701)

Porto, 4200-072, Portugal

Location

Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 2803)

Cluj-Napoca, Cluj, 400015, Romania

Location

Amethyst Radiotherapy Center-Oncologie Medicala ( Site 2805)

Florești, Cluj, 407280, Romania

Location

Spitalul Municipal Ploiesti ( Site 2801)

Ploieşti, Prahova, 100337, Romania

Location

Cabinet Medical Oncomed ( Site 2802)

Timișoara, Timiș County, 300239, Romania

Location

S.C.Focus Lab Plus S.R.L ( Site 2804)

Bucharest, 022548, Romania

Location

Main Military Clinical Hospital n.a. N.N.Burdenko ( Site 1812)

Moscow, Moscow, 105094, Russia

Location

MROI n.a. P.A. Herzen - branch of FSBI NMICR of MoH of Russia ( Site 1800)

Moscow, Moscow, 125284, Russia

Location

Moscow Regional Oncological Dispensary-Oncology (thoracic surgery) Department №1 ( Site 1815)

Balashikha, Moscow Oblast, 143900, Russia

Location

Nizhniy Novgorod Region Oncology Dispensary ( Site 1811)

Nizhny Novgorod, Nizhny Novgorod Oblast, 603081, Russia

Location

Omsk Clinical Oncology Dispensary ( Site 1806)

Omsk, Omsk Oblast, 644013, Russia

Location

Sverdlovsk Regional Oncology Hospital ( Site 1807)

Yekaterinburg, Sverdlovsk Oblast, 620036, Russia

Location

Republican Clinical Oncology Dispensary-Chemotherapy #1 ( Site 1814)

Kazan', Tatarstan, Respublika, 420029, Russia

Location

Institute for Oncology and Radiology of Serbia ( Site 2995)

Belgrade, Beograd, 11000, Serbia

Location

Institut za plucne bolesti Vojvodine Sremska Kamenica ( Site 2991)

Kamenitz, Sremski Okrug, 21204, Serbia

Location

Steve Biko Academic Hospital ( Site 5000)

Pretoria, Gauteng, 0002, South Africa

Location

Groote Schuur Hospital ( Site 5002)

Cape Town, Western Cape, 7925, South Africa

Location

National Cancer Center ( Site 3306)

Goyang-si, Kyonggi-do, 10408, South Korea

Location

Seoul National University Bundang Hospital ( Site 3301)

Seongnam-si, Kyonggi-do, 13620, South Korea

Location

The Catholic University of Korea St. Vincent s Hospital ( Site 3303)

Suwon, Kyonggi-do, 16247, South Korea

Location

Inje University Haeundae Paik Hospital ( Site 3307)

Busan, Pusan-Kwangyokshi, 48108, South Korea

Location

Asan Medical Center ( Site 3308)

Songpagu, Seoul, 05505, South Korea

Location

Keimyung University Dongsan Hospital CRC room 1 ( Site 3302)

Daegu, Taegu-Kwangyokshi, 42601, South Korea

Location

Severance Hospital Yonsei University Health System ( Site 3304)

Seoul, 03722, South Korea

Location

Samsung Medical Center ( Site 3300)

Seoul, 06351, South Korea

Location

Hospital Duran i Reynals ( Site 1903)

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

Location

Hospital Universitario Central de Asturias ( Site 1900)

Oviedo, Principality of Asturias, 33011, Spain

Location

Hospital Universitari Vall d Hebron ( Site 1904)

Barcelona, 08035, Spain

Location

Hospital Universitario 12 de Octubre ( Site 1902)

Madrid, 28041, Spain

Location

Hospital Regional Universitario de Malaga ( Site 1905)

Málaga, 29010, Spain

Location

Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 1907)

Seville, 41009, Spain

Location

Ankara Bilkent Sehir Hastanesi ( Site 2007)

Ankara, 06800, Turkey (Türkiye)

Location

Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 2009)

Istanbul, 34098, Turkey (Türkiye)

Location

Medipol Universite Hastanesi ( Site 2005)

Istanbul, 34214, Turkey (Türkiye)

Location

Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 2003)

Istanbul, 34722, Turkey (Türkiye)

Location

Ege Universitesi Tip Fakultesi Hastanesi ( Site 2001)

Izmir, 35040, Turkey (Türkiye)

Location

Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 2110)

Kharkiv, Kharkivs’ka Oblast’, 61024, Ukraine

Location

Municipal non-profit Enterprise "Khmelnytskyi Regional Antitumor Center" ( Site 2115)

Khmelnytskyi, Khmelnytskyi Oblast, 29009, Ukraine

Location

LISOD. Hospital ( Site 2111)

Pliuty, Kyiv Oblast, 08720, Ukraine

Location

Medical Center of Yuriy Spizhenko LLC.-Clinical Trial ( Site 2104)

Kapitanivka Village, Kyivska Oblast, 08111, Ukraine

Location

Clinic of National Cancer Institute ( Site 2101)

Kyiv, Kyivska Oblast, 03022, Ukraine

Location

Medical Center Verum ( Site 2106)

Kyiv, Kyivska Oblast, 03039, Ukraine

Location

Communal Noncommercial Enterprise "Podillia Regional Oncolog-Chemotherapy Department ( Site 2114)

Vinnytsia, Vinnytsia Oblast, 21029, Ukraine

Location

Kyiv City Clinical Oncology Center ( Site 2100)

Kyiv, 03115, Ukraine

Location

Royal Infirmary Aberdeen ( Site 2403)

Aberdeen, Aberdeen City, AB25 2ZN, United Kingdom

Location

Ninewells Hospital and Medical School ( Site 2401)

Dundee, Dundee City, DD1 9SY, United Kingdom

Location

Taunton and Somerset Hospital ( Site 2404)

Taunton, England, TA1 5DA, United Kingdom

Location

Barts Health NHS Trust ( Site 2409)

London, London, City of, EC1A 7BE, United Kingdom

Location

Guy s & St Thomas NHS Foundation Trust ( Site 2408)

London, London, City of, SE1 9RT, United Kingdom

Location

The Christie NHS Foundation Trust ( Site 2405)

Manchester, M20 4GJ, United Kingdom

Location

Related Publications (1)

• Rimner A, Lai WV, Califano R, Jabbour SK, Rudin CM, Faivre-Finn C, Cho BC, Kato T, Yu J, Chafin W, Yu L, Zhao B, Byers L. Rationale and Design of the Phase 3 KEYLYNK-013 Study of Pembrolizumab With Concurrent Chemoradiotherapy Followed by Pembrolizumab With or Without Olaparib for Limited-Stage Small-Cell Lung Cancer. Clin Lung Cancer. 2022 Jul;23(5):e325-e329. doi: 10.1016/j.cllc.2022.04.005. Epub 2022 Apr 29.

  PMID: 35613997 DERIVED

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Small Cell Lung Carcinoma; Parkinson Disease 4, Autosomal Dominant Lewy Body

Interventions

pembrolizumab; Sodium Chloride; olaparib; BID protein, human; Etoposide; Platinum

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Metals, Heavy; Elements; Transition Elements; Metals

Study Officials

• Medical Director, MD

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2020
• First Posted: November 10, 2020
• Study Start: December 8, 2020
• Primary Completion (Estimated): October 28, 2027
• Study Completion (Estimated): October 28, 2027
• Last Updated: July 2, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share

Locations

GB (6); RO (5); US (35); KR (8); AU (7); BU (1); CA (5); UA (8); FR (9); JP (16); ME (2); ES (6); CN (28); BE (6); PT (3); HU (6); ZA (2); SE (2); IL (2); TU (5); GR (5); LI (2); IT (9); RU (7)