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)

Small Cell Lung Cancer Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04624204
• Other study ID #: 7339-013
• Secondary ID: MK-7339-013jRCT2
• Status: Recruiting
• Phase: Phase 3
• Start date: December 8, 2020
• Est. completion date: October 28, 2027

Study information

• Verified date: June 2024
• Source: Merck Sharp & Dohme LLC
• Contact: Toll Free Number
• Phone: 1-888-577-8839
• Email: Trialsites[@]merck.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 672
• Est. completion date: October 28, 2027
• Est. primary completion date: October 28, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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: 7 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.

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

Biological:
• Pembrolizumab 200 mg
Pembrolizumab 200 mg Q3W
• Pembrolizumab 400 mg
Pembrolizumab 400 mg Q6W

Drug:
• 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

Radiation:
• 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.

Locations

Country	Name	City	State
Australia	Campbelltown Hospital ( Site 3002)	Campbelltown	New South Wales
Australia	Frankston Hospital-Oncology and Haematology ( Site 3007)	Frankston	Victoria
Australia	Austin Health-Austin Hospital ( Site 3006)	Heidelberg	Victoria
Australia	Nepean Hospital ( Site 3001)	Kingswood	New South Wales
Australia	Gold Coast University Hospital ( Site 3003)	Southport	Queensland
Australia	Western Health-Sunshine Hospital ( Site 3004)	St Albans	Victoria
Australia	Calvary Mater Newcastle ( Site 3000)	Waratah	New South Wales
Belgium	Saint-Luc UCL ( Site 1005)	Brussels	Bruxelles-Capitale, Region De
Belgium	Grand Hopital de Charleroi ( Site 1003)	Charleroi	Hainaut
Belgium	UZ Leuven ( Site 1002)	Leuven	Vlaams-Brabant
Belgium	C.I.U. Hopital Ambroise Pare ( Site 1001)	Mons	Hainaut
Belgium	AZ Delta ( Site 1000)	Roeselare	West-Vlaanderen
Belgium	CHU UCL Namur Site de Godinne ( Site 1004)	Yvoir	Namur
Bulgaria	MHAT "Uni Hospital" OOD ( Site 2507)	Panagyurishte	Pazardzhik
Canada	Cross Cancer Institute ( Site 0206)	Edmonton	Alberta
Canada	Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0212)	Hamilton	Ontario
Canada	CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 0202)	Montreal	Quebec
Canada	McGill University Health Centre ( Site 0210)	Montréal	Quebec
Canada	CIUSSS de la Mauricie et du Centre du Quebec ( Site 0200)	Trois-Rivieres	Quebec
China	Beijing Cancer Hospital ( Site 3127)	Beijing	Beijing
China	Beijing Cancer hospital-Oncology Radiotherapy Department ( Site 3140)	Beijing	Beijing
China	Cancer Hospital Chinese Academy of Medical Sciences ( Site 3104)	Beijing	Beijing
China	Peking Union Medical College Hospital ( Site 3102)	Beijing	Beijing
China	The First Hospital of Jilin University ( Site 3132)	Changchun	Jilin
China	Hunan Cancer Hospital ( Site 3133)	Changsha	Hunan
China	Second Xiangya Hospital of Central-South University ( Site 3128)	Changsha	Hunan
China	Xiangya Hospital of Central South University ( Site 3137)	Changsha	Hunan
China	West China Hospital of Sichuan University ( Site 3114)	Chengdu	Sichuan
China	Chongqing Cancer Hospital ( Site 3135)	Chongqing	Chongqing
China	Daping Hospital,Third Military Medical University ( Site 3136)	Chongqing	Chongqing
China	Fujian Provincial Cancer Hospital ( Site 3126)	Fuzhou	Fujian
China	Hangzhou Cancer Hospital ( Site 3129)	Hanghzou	Zhejiang
China	The 1st Affil Hosp of College of Medicine, Zhejiang Univ ( Site 3131)	Hangzhou	Zhejiang
China	Zhejiang Cancer Hospital.... ( Site 3108)	Hangzhou	Zhejiang
China	Shandong Province Cancer Hospital ( Site 3100)	Jinan	Shandong
China	The Second Affiliated Hospital of Nanchang University ( Site 3106)	Nanchang	Jiangxi
China	Jiangsu Cancer Hospital ( Site 3139)	Nanjing	Jiangsu
China	Shanghai Chest Hospital ( Site 3107)	Shangai	Shanghai
China	Shanghai Pulmonary Hospital ( Site 3101)	Shanghai	Shanghai
China	Cancer Hospital Chinese Academy Of Medical Sciences. Shenzhen Center ( Site 3113)	Shenzhen	Guangdong
China	Peking University Shenzhen Hospital ( Site 3118)	Shenzhen	Guangdong
China	Tianjin Medical University Cancer Institute & Hospital ( Site 3103)	Tianjin	Tianjin
China	Hubei Cancer Hospital ( Site 3120)	Wuhan	Hubei
China	Tongji Medical College Huazhong University of Science and Technology ( Site 3138)	Wuhan	Hubei
China	Wuhan Union Hospital ( Site 3123)	Wuhan	Hubei
China	The First Affiliated Hospital of Xiamen University ( Site 3121)	Xiamen	Fujian
China	Henan Cancer Hospital ( Site 3105)	Zhengzhou	Henan
Estonia	SA Pohja-Eesti Regionaalhaigla ( Site 2201)	Tallinn	Harjumaa
Estonia	SA Tartu Ulikooli Kliinikum ( Site 2200)	Tartu	Tartumaa
France	Institut de Cancerologie de l Ouest Site Paul Papin ( Site 1103)	Angers	Maine-et-Loire
France	Hopital Avicenne ( Site 1106)	Bobigny	Seine-Saint-Denis
France	CHU de Bordeaux Hop St ANDRE ( Site 1115)	Bordeaux	Aquitaine
France	CHU Grenoble -Hop Michallon ( Site 1102)	Grenoble	Isere
France	Clinique Clairval ( Site 1108)	Marseille	Bouches-du-Rhone
France	Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 1105)	Paris	Ile-de-France
France	Institut De Cancerologie De L Ouest ( Site 1110)	Saint Herblain	Loire-Atlantique
France	C.H. de Saint Quentin ( Site 1111)	Saint Quentin	Aisne
France	H.I.A. Sainte-Anne ( Site 1101)	Toulon	Var
Greece	Henry Dunant Hospital ( Site 1205)	Athens	Attiki
Greece	Sotiria Regional Chest Diseases Hospital of Athens ( Site 1200)	Athens	Attiki
Greece	University General Hospital of Herakleion ( Site 1202)	Heraklion	Irakleio
Greece	University General Hospital of Larisa ( Site 1201)	Larissa	Thessalia
Greece	Anti-Cancer Hospital of Thessaloniki Theagenio ( Site 1204)	Thessaloniki	Kentriki Makedonia
Hungary	Orszagos Koranyi Pulmonologiai Intezet ( Site 1301)	Budapest
Hungary	Orszagos Onkologiai Intezet ( Site 1310)	Budapest
Hungary	Uzsoki Utcai Korhaz ( Site 1303)	Budapest
Hungary	Petz Aladar Megyei Oktato Korhaz ( Site 1312)	Gyor	Gyor-Moson-Sopron
Hungary	Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 1306)	Kecskemét	Bacs-Kiskun
Hungary	Reformatus Pulmonologiai Centrum ( Site 1304)	Torokbalint	Pest
Israel	Rambam Health Care Campus-Oncology Division ( Site 1401)	Haifa
Israel	Chaim Sheba Medical Center ( Site 1400)	Ramat Gan
Italy	Azienda Ospedaliera Spedali Civili di Brescia ( Site 1512)	Brescia
Italy	Azienda Ospedaliero Universitaria Careggi ( Site 1509)	Florence	Firenze
Italy	IRCCS Ospedale San Raffaele ( Site 1500)	Milano
Italy	Istituto Europeo di Oncologia ( Site 1501)	Milano
Italy	Istituto Nazionale dei Tumori ( Site 1504)	Milano
Italy	A O U Policlinico di Modena ( Site 1503)	Modena	Emilia-Romagna
Italy	IRCCS Istituto Oncologico Veneto ( Site 1506)	Padova
Italy	Policlinico Universitario Agostino Gemelli ( Site 1505)	Roma
Italy	Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento-Oncology Unit ( Site 1513	Verona	Veneto
Japan	National Hospital Organization Kyushu Cancer Center ( Site 4000)	Fukuoka
Japan	Kansai Medical University Hospital ( Site 4009)	Hirakata	Osaka
Japan	Kobe Minimally Invasive Cancer Center ( Site 4003)	Kobe	Hyogo
Japan	Shizuoka Cancer Center ( Site 4014)	Nagaizumi	Shizuoka
Japan	Aichi Cancer Center Hospital ( Site 4010)	Nagoya	Aichi
Japan	Niigata Cancer Center Hospital ( Site 4004)	Niigata
Japan	Okayama University Hospital ( Site 4012)	Okayama
Japan	Osaka International Cancer Institute ( Site 4005)	Osaka
Japan	Takarazuka City Hospital ( Site 4013)	Takarazuka	Hyogo
Japan	Osaka Medical and Pharmaceutical University Hospital ( Site 4007)	Takatsuki	Osaka
Japan	Juntendo University Hospital ( Site 4008)	Tokyo
Japan	National Cancer Center Hospital ( Site 4015)	Tokyo
Japan	Showa University Hospital ( Site 4002)	Tokyo
Japan	The Cancer Institute Hospital of JFCR ( Site 4006)	Tokyo
Japan	Tokyo Metropolitan Komagome Hospital ( Site 4011)	Tokyo
Japan	Kanagawa Cancer Center ( Site 4001)	Yokohama	Kanagawa
Korea, Republic of	Inje University Haeundae Paik Hospital ( Site 3307)	Busan	Pusan-Kwangyokshi
Korea, Republic of	Keimyung University Dongsan Hospital CRC room 1 ( Site 3302)	Daegu	Taegu-Kwangyokshi
Korea, Republic of	National Cancer Center ( Site 3306)	Goyang-si	Kyonggi-do
Korea, Republic of	Seoul National University Bundang Hospital ( Site 3301)	Seongnam-si	Kyonggi-do
Korea, Republic of	Samsung Medical Center ( Site 3300)	Seoul
Korea, Republic of	Severance Hospital Yonsei University Health System ( Site 3304)	Seoul
Korea, Republic of	Asan Medical Center ( Site 3308)	Songpagu	Seoul
Korea, Republic of	The Catholic University of Korea St. Vincent s Hospital ( Site 3303)	Suwon-si	Kyonggi-do
Lithuania	LSMUL Kauno Klinikos ( Site 2301)	Kaunas
Lithuania	Nacionalinis Vezio Institutas ( Site 2300)	Vilnius	Vilniaus Miestas
Mexico	Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0401)	Guadalajara	Jalisco
Mexico	Hospital Universitario "Dr. Jose Eleuterio Gonzalez" ( Site 0404)	Monterrey	Nuevo Leon
Portugal	Centro Hospitalar Lisboa Norte E.P.E. - Hospital Pulido Valente ( Site 1704)	Lisboa
Portugal	Inst. Portugues de Oncologia de Lisboa Francisco Gentil EPE ( Site 1705)	Lisboa
Portugal	Instituto Portugues de Oncologia Do Porto Francisco Gentil E.P.E. ( Site 1701)	Porto
Romania	S.C.Focus Lab Plus S.R.L ( Site 2804)	Bucuresti
Romania	Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 2803)	Cluj-Napoca	Cluj
Romania	Amethyst Radiotherapy Center-Oncologie Medicala ( Site 2805)	Flore?ti	Cluj
Romania	Spitalul Municipal Ploiesti ( Site 2801)	Ploiesti	Prahova
Romania	Cabinet Medical Oncomed ( Site 2802)	Timisoara	Timis
Russian Federation	Moscow Regional Oncological Dispensary-Oncology (thoracic surgery) Department ?1 ( Site 1815)	Balashikha	Moskovskaya Oblast
Russian Federation	Sverdlovsk Regional Oncology Hospital ( Site 1807)	Ekaterinburg	Sverdlovskaya Oblast
Russian Federation	Republican Clinical Oncology Dispensary-Chemotherapy #1 ( Site 1814)	Kazan	Tatarstan, Respublika
Russian Federation	Main Military Clinical Hospital n.a. N.N.Burdenko ( Site 1812)	Moscow	Moskva
Russian Federation	MROI n.a. P.A. Herzen - branch of FSBI NMICR of MoH of Russia ( Site 1800)	Moscow	Moskva
Russian Federation	Nizhniy Novgorod Region Oncology Dispensary ( Site 1811)	Nizhny Novgorod	Nizhegorodskaya Oblast
Russian Federation	Omsk Clinical Oncology Dispensary ( Site 1806)	Omsk	Omskaya Oblast
Serbia	Institute for Oncology and Radiology of Serbia ( Site 2995)	Belgrade	Beograd
Serbia	Institut za plucne bolesti Vojvodine Sremska Kamenica ( Site 2991)	Sremska Kamenica	Sremski Okrug
South Africa	Groote Schuur Hospital ( Site 5002)	Cape Town	Western Cape
South Africa	Steve Biko Academic Hospital ( Site 5000)	Pretoria	Gauteng
Spain	Hospital Universitari Vall d Hebron ( Site 1904)	Barcelona
Spain	Hospital Duran i Reynals ( Site 1903)	Hospitalet de Llobregat	Barcelona
Spain	Hospital Universitario 12 de Octubre ( Site 1902)	Madrid
Spain	Hospital Regional Universitario de Malaga ( Site 1905)	Malaga
Spain	Hospital Universitario Central de Asturias ( Site 1900)	Oviedo	Asturias
Spain	Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 1907)	Sevilla
Turkey	Ankara Bilkent Sehir Hastanesi ( Site 2007)	Ankara
Turkey	Göztepe Prof. Dr. Süleyman Yalçin Sehir Hastanesi-oncology ( Site 2003)	Istanbul
Turkey	Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 2009)	Istanbul
Turkey	Medipol Universite Hastanesi ( Site 2005)	Istanbul
Turkey	Ege Universitesi Tip Fakultesi Hastanesi ( Site 2001)	Izmir
Ukraine	Medical center Medikal Plaza of Ecodnipro LLC ( Site 2107)	Dnipro	Dnipropetrovska Oblast
Ukraine	Medical Center of Yuriy Spizhenko LLC.-Clinical Trial ( Site 2104)	Kapitanivka Village	Kyivska Oblast
Ukraine	Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 2110)	Kharkiv	Kharkivska Oblast
Ukraine	Municipal non-profit Enterprise "Khmelnytskyi Regional Antitumor Center" ( Site 2115)	Khmelnytskyi	Khmelnytska Oblast
Ukraine	Clinic of National Cancer Institute ( Site 2101)	Kyiv	Kyivska Oblast
Ukraine	Kyiv City Clinical Oncology Center ( Site 2100)	Kyiv
Ukraine	Medical Center Verum ( Site 2106)	Kyiv	Kyivska Oblast
Ukraine	LISOD. Hospital ( Site 2111)	Pliuty	Kyiv
Ukraine	Communal Noncommercial Enterprise "Podillia Regional Oncolog-Chemotherapy Department ( Site 2114)	Vinnytsia	Vinnytska Oblast
United Kingdom	Royal Infirmary Aberdeen ( Site 2403)	Aberdeen	Aberdeen City
United Kingdom	Ninewells Hospital and Medical School ( Site 2401)	Dundee	Dundee City
United Kingdom	Barts Health NHS Trust ( Site 2409)	London	London, City Of
United Kingdom	Guy s & St Thomas NHS Foundation Trust ( Site 2408)	London	London, City Of
United Kingdom	The Christie NHS Foundation Trust ( Site 2405)	Manchester
United Kingdom	Taunton and Somerset Hospital ( Site 2404)	Taunton	England
United States	VA Ann Arbor Healthcare System ( Site 0050)	Ann Arbor	Michigan
United States	Harry & Jeanette Weinberg Cancer Institute ( Site 0045)	Baltimore	Maryland
United States	Memorial Sloan Kettering - Basking Ridge ( Site 0133)	Basking Ridge	New Jersey
United States	St. Vincent Healthcare Frontier Cancer Center ( Site 0056)	Billings	Montana
United States	Ironwood Cancer & Research Centers ( Site 0007)	Chandler	Arizona
United States	University of Chicago Medical Center ( Site 0136)	Chicago	Illinois
United States	Cleveland Clinic Main ( Site 0139)	Cleveland	Ohio
United States	Fairview Hospital-Moll Cancer Center ( Site 0141)	Cleveland	Ohio
United States	Memorial Sloan Kettering- Commack ( Site 0132)	Commack	New York
United States	Texas Oncology - Dallas (Presbyterian)_McIntyre ( Site 0098)	Dallas	Texas
United States	Texas Oncology - Dallas (Sammons) ( Site 0093)	Dallas	Texas
United States	Providence Regional Cancer Partnership ( Site 0106)	Everett	Washington
United States	Fort Wayne Medical Oncology and Hematology ( Site 0034)	Fort Wayne	Indiana
United States	Saint Francis Cancer Center ( Site 0087)	Greenville	South Carolina
United States	John Theurer Cancer Center ( Site 0064)	Hackensack	New Jersey
United States	Memorial Sloan Kettering - Westchester-Thoracic Oncology ( Site 0134)	Harrison	New York
United States	Penn State Hershey Cancer Institute ( Site 0081)	Hershey	Pennsylvania
United States	MD Anderson Cancer Center ( Site 0100)	Houston	Texas
United States	Millennium Research & Clinical Development ( Site 0143)	Houston	Texas
United States	The University of Tennessee Medical Center ( Site 0116)	Knoxville	Tennessee
United States	University of Kentucky Chandler Medical Center ( Site 0138)	Lexington	Kentucky
United States	Loma Linda University Cancer Center ( Site 0011)	Loma Linda	California
United States	Cleveland Clinic - Hillcrest Hospital-Hillcrest Hospital Cancer Center ( Site 0140)	Mayfield Heights	Ohio
United States	Memorial Sloan Kettering - Monmouth ( Site 0135)	Middletown	New Jersey
United States	Memorial Sloan Kettering - Bergen ( Site 0130)	Montvale	New Jersey
United States	Rutgers Cancer Institute of New Jersey ( Site 0123)	New Brunswick	New Jersey
United States	Memorial Sloan Kettering Cancer Center ( Site 0069)	New York	New York
United States	Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0061)	Omaha	Nebraska
United States	Overton Brooks VAMC ( Site 0041)	Shreveport	Louisiana
United States	Medical Oncology Associates, PS ( Site 0142)	Spokane	Washington
United States	Multicare Institute For Research And Innovation ( Site 0108)	Tacoma	Washington
United States	Moffitt Cancer Center ( Site 0137)	Tampa	Florida
United States	Memorial Sloan Kettering - Nassau ( Site 0131)	Uniondale	New York
United States	Georgetown University ( Site 0017)	Washington	District of Columbia
United States	Virginia Mason Memorial- North Star Lodge Cancer Center ( Site 0112)	Yakima	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme LLC

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Bulgaria,  Canada,  China,  Estonia,  France,  Greece,  Hungary,  Israel,  Italy,  Japan,  Korea, Republic of,  Lithuania,  Mexico,  Portugal,  Romania,  Russian Federation,  Serbia,  South Africa,  Spain,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Number of Participants Experiencing an Adverse Events (AEs)	An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.	Up to approximately 82 months
Secondary	Number of Participants Discontinuing Study Treatment Due to Adverse Events (AEs)	An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.	Up to approximately 82 months
Secondary	Objective Response (OR): Complete Response (CR) or Partial Response (PR)	Percentage of participants in the analysis population who have a best overall response of either confirmed CR or a PR per RECIST 1.1.	Up to approximately 82 months
Secondary	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	DOR is 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
Secondary	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	The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "How would you rate your overall health during the past week?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 scores will be presented.	Baseline and 82 months post randomization
Secondary	Change from Baseline at Cycle 1 in EORTC Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Cough (Item 1) Scale Score	The EORTC QLQ-LC13 is a lung cancer specific supplemental questionnaire used in combination with the EORTC QLQC30 questionnaire. Participant responses to the question "How much did you cough?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. The change from baseline in EORTC QLQ-LC13 cough (Item 1) score will be presented.	Baseline and 82 months post randomization
Secondary	Change from Baseline at Cycle 1 in EORTC QLQ-LC13 Chest Pain (Item 10) Scale Score	The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQC30 questionnaire. Participant responses to the question "How was your chest pain?" are scored on a 4 point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. The change from baseline in EORTC QLQ-LC13 chest pain (Item 10) score will be presented.	Baseline and 82 months post randomization
Secondary	Change from Baseline at Cycle 1 in EORTC QLQ-C30 Dyspnea (Item 8) Scale Score	The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. The change from baseline in EORTC QLQ-LC13 dyspnea (Item 8) score will be presented.	Baseline and 82 months post randomization
Secondary	Change from Baseline at Cycle 1 in EORTC QLQ-C30 Physical Functioning (Items 1 to 5) Scale Score	The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better quality of life. The change from baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) score will be presented.	Baseline and 82 months post randomization
Secondary	Time to True Deterioration (TTD) in EORTC QLQ-C30 Global Health Status / Quality of Life (Items 29 & 30) Scale Score	The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "How would you rate your overall health during the past week?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. TTD was defined as the time from baseline (at randomization) to the first onset of a =10-point decrease with confirmation by the subsequent visit of a =10-point decrease in EORTC QLQ-C30 Items 29 and 30 scale scores.	Up to approximately 82 months post randomization
Secondary	Time to True Deterioration (TTD) in Cough (LC13/Item 1) Scale Score	The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQC30 questionnaire. Participant responses to the question "How much did you cough?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. TTD was defined as the time from baseline (at randomization) to the first onset of a =10-point decrease with confirmation by the subsequent visit of a =10-point decrease in cough EORTC QLQLC13 cough (Item 1) scale score.	Up to approximately 82 months post randomization
Secondary	Time to True Deterioration (TTD) in Chest Pain (LC13/Item 10) Scale Score	The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQC30 questionnaire. Participant responses to the question "How was your chest pain?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. TTD was defined as the time from baseline (at randomization) to the first onset of a =10-point decrease with confirmation by the subsequent visit of a =10-point decrease in EORTC QLQ-LC13 chest pain (Item 10) scale score.	Up to approximately 82 months post randomization
Secondary	Time to True Deterioration (TTD) in EORTC QLQ-C30 Dyspnea (Item 8) Scale Score	The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. TTD was defined as the time from baseline (at randomization) to the first onset of a =10-point decrease with confirmation by the subsequent visit of a =10-point decrease in EORTC QLQ-C30 dyspnea (Item 8) scale score.	Up to approximately 82 months post randomization
Secondary	Time to True Deterioration (TTD) in EORTC QLQ-C30 Physical Functioning (Items 1 to 5) Scale Score	The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better quality of life. TTD was defined as the time from baseline (at randomization) to the first onset of a =10-point decrease with confirmation by the subsequent visit of a =10-point decrease in EORTC QLQ-C30 physical functioning (Items 1 to 5) scale scores.	Up to approximately 82 months post randomization
Secondary	Objective Response (OR, according to RECIST 1.1 by BICR) assessed by programmed cell death ligand 1 (PD-L1) expression levels	Percentage of participants in the analysis population who have a best overall response of either confirmed CR or a PR per RECIST 1.1, analyzed by programmed cell death ligand 1 (PD-L1) expression levels.	Up to approximately 82 months
Secondary	Duration of Response (DOR, according to RECIST 1.1 by BICR) assessed by programmed cell death ligand 1 (PD-L1) expression levels	DOR is 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, analyzed by programmed cell death ligand 1 (PD-L1) expression levels.	Up to approximately 82 months
Secondary	Progression-free Survival (PFS, according to RECIST 1.1 by BICR) assessed by programmed cell death ligand 1 (PD-L1) expression levels	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, analyzed by programmed cell death ligand 1 (PD-L1) expression levels.	Up to approximately 59 months
Secondary	Overall Survival (OS) assessed by programmed cell death ligand 1 (PD-L1) expression levels	Overall Survival: the time from randomization to death due to any cause, analyzed by programmed cell death ligand 1 (PD-L1) expression levels.	Up to approximately 82 months

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