Lung Cancer Clinical Trial
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)
Summary
The purpose of this study is to compare overall survival (OS) and progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR).
Hypothesis (H1): Concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab plus olaparib is superior to concurrent chemoradiation therapy alone with respect to PFS per RECIST 1.1 by BICR.
Hypothesis (H2): Concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab is superior to concurrent chemoradiation therapy alone with respect to PFS per RECIST 1.1 by BICR.
Hypothesis (H3): Concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab plus olaparib is superior to concurrent chemoradiation therapy alone with respect to OS.
Hypothesis (H4): Concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab is superior to concurrent chemoradiation therapy alone with respect to OS.
Eligibility Criteria
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:
Pembrolizumab: 120 days
Olaparib: 7 days
Exclusion Criteria:
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.
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There are 171 Locations for this study
Loma Linda California, 92350, United States More Info
Washington District of Columbia, 20007, United States
Fort Wayne Indiana, 46804, United States More Info
Lexington Kentucky, 40536, United States More Info
Shreveport Louisiana, 71101, United States
Baltimore Maryland, 21237, United States More Info
Billings Montana, 59102, United States
Omaha Nebraska, 68130, United States More Info
Basking Ridge New Jersey, 07920, United States More Info
Hackensack New Jersey, 07601, United States
Middletown New Jersey, 07748, United States More Info
New Brunswick New Jersey, 08901, United States More Info
Harrison New York, 10604, United States More Info
New York New York, 10021, United States More Info
Hershey Pennsylvania, 17033, United States
Greenville South Carolina, 29607, United States
Knoxville Tennessee, 37920, United States More Info
Dallas Texas, 75231, United States
Everett Washington, 98201, United States More Info
Tacoma Washington, 98405, United States
Yakima Washington, 98902, United States More Info
Frankston Victoria, 3199, Australia More Info
Hamilton Ontario, L8V 5, Canada More Info
Trois-Rivieres Quebec, G8Z 3, Canada More Info
Beijing Beijing, 10002, China
Beijing Beijing, 10014, China
Chongqing Chongqing, 40003, China
Chongqing Chongqing, 40004, China
Xiamen Fujian, 36100, China More Info
Shenzhen Guangdong, 51811, China More Info
Wuhan Hubei, 43002, China
Wuhan Hubei, 43003, China
Changsha Hunan, 41000, China
Changsha Hunan, 41001, China More Info
Nanchang Jiangxi, 33000, China More Info
Changchun Jilin, 13002, China
Shangai Shanghai, 20003, China
Chengdu Sichuan, 51011, China
Tianjin Tianjin, 30006, China
Hangzhou Zhejiang, 31000, China More Info
Tallinn Harjumaa, 13419, Estonia
Paris Ile-de-France, 75014, France More Info
Saint Herblain Loire-Atlantique, 44805, France More Info
Angers Maine-et-Loire, 49000, France More Info
Bobigny Seine-Saint-Denis, 93000, France
Athens Attiki, 115 2, Greece More Info
Thessaloniki Kentriki Makedonia, 54007, Greece
Kecskemét Bacs-Kiskun, 6000, Hungary More Info
Budapest , 1145, Hungary
Takatsuki Osaka, 56986, Japan More Info
Seongnam-si Kyonggi-do, 13620, Korea, Republic of More Info
Suwon-si Kyonggi-do, 16247, Korea, Republic of More Info
Busan Pusan-Kwangyokshi, 48108, Korea, Republic of More Info
Daegu Taegu-Kwangyokshi, 42601, Korea, Republic of
Seoul , 03722, Korea, Republic of More Info
Guadalajara Jalisco, 44280, Mexico More Info
Monterrey Nuevo Leon, 64460, Mexico More Info
Lisboa , 1099-, Portugal More Info
Porto , 4200-, Portugal More Info
Florești Cluj, 40728, Romania More Info
Balashikha Moskovskaya Oblast, 14390, Russian Federation
Moscow Moskva, 10509, Russian Federation
Moscow Moskva, 12528, Russian Federation
Nizhny Novgorod Nizhegorodskaya Oblast, 60308, Russian Federation
Omsk Omskaya Oblast, 64401, Russian Federation
Ekaterinburg Sverdlovskaya Oblast, 62003, Russian Federation
Kazan Tatarstan, Respublika, 42002, Russian Federation
Belgrade Beograd, 11000, Serbia More Info
Sremska Kamenica Sremski Okrug, 21204, Serbia More Info
Sevilla , 41009, Spain More Info
Istanbul , 34722, Turkey More Info
Dnipro Dnipropetrovska Oblast, 49055, Ukraine
Kharkiv Kharkivska Oblast, 61024, Ukraine
Kapitanivka Village Kyivska Oblast, 08111, Ukraine
Kyiv Kyivska Oblast, 03022, Ukraine
Kyiv Kyivska Oblast, 03039, Ukraine
Pliuty Kyiv, 08720, Ukraine
Kyiv , 03115, Ukraine
Dundee Dundee City, DD1 9, United Kingdom More Info
London London, City Of, SE1 9, United Kingdom More Info
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