A Randomized, Double-blind, Placebo-controlled Phase 3 Study of Pembrolizumab (MK-3475) in Combination With Concurrent Chemoradiation Therapy Followed by Pembrolizumab With or Without Olaparib (MK-7339), Compared to Concurrent Chemoradiation Therapy Alone in Participants With Newly Diagnosed Treatment-Naïve Limited-Stage Small Cell Lung Cancer (LS-SCLC)
A Randomized, Double-blind, Placebo-controlled Phase 3 Study of Pembrolizumab (MK-3475) in Combination With Concurrent Chemoradiation Therapy Followed by Pembrolizumab With or Without Olaparib (MK-7339), Compared to Concurrent Chemoradiation Therapy Alone in Participants With Newly Diagnosed Treatment-Naïve Limited-Stage Small Cell Lung Cancer (LS-SCLC)
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.
Inclusion Criteria:
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:
Exclusion Criteria:
Omaha, Nebraska 68130, United States
Harrison, New York 10604, United States
Mayfield Heights, Ohio 44124, United States
Yakima, Washington 98902, United States
Beijing, Beijing Municipality 100021, China
Beijing, Beijing Municipality 100142, China
Chongqing, Chongqing Municipality 400042, China
Shenzhen, Guangdong 518116, China
Wuhan, Hubei 430030, China
Jinan, Shandong 250117, China
Tianjin, Tianjin Municipality 300060, China
Hanghzou, Zhejiang 310002, China
Hangzhou, Zhejiang 310003, China
Angers, Maine-et-Loire 49000, France
Paris, Île-de-France Region 75014, France
Thessaloniki, Central Macedonia 54007, Greece
Kecskemét, Bács-Kiskun county 6000, Hungary
Verona, Veneto 37126, Italy
Monterrey, Nuevo León 64460, Mexico
Lisbon, Lisbon District 1769-001, Portugal
Porto, 4200-072, Portugal
Cluj-Napoca, Cluj 400015, Romania
Florești, Cluj 407280, Romania
Moscow, Moscow 125284, Russia
Balashikha, Moscow Oblast 143900, Russia
Nizhny Novgorod, Nizhny Novgorod Oblast 603081, Russia
Kazan', Tatarstan, Respublika 420029, Russia
Kamenitz, Sremski Okrug 21204, Serbia
Suwon, Kyonggi-do 16247, South Korea
Songpagu, Seoul 05505, South Korea
Daegu, Taegu-Kwangyokshi 42601, South Korea
Oviedo, Principality of Asturias 33011, Spain
Seville, 41009, Spain
Istanbul, 34722, Turkey (Türkiye)
Kharkiv, Kharkiv Oblast 61024, Ukraine
Khmelnytskyi, Khmelnytskyi Oblast 29009, Ukraine
Kapitanivka Village, Kyivska Oblast 08111, Ukraine
Vinnytsia, Vinnytsia Oblast 21029, Ukraine