Study of Pembrolizumab With Maintenance Olaparib or Maintenance Pemetrexed in First-line (1L) Metastatic Non-squamous Non-Small-Cell Lung Cancer (NSCLC) (MK-7339-006, KEYLYNK-006)

Carcinoma, Non-squamous Non-small-cell Lung Clinical Trial

Official title:

A Phase 3 Study of Pembrolizumab in Combination With Pemetrexed/Platinum (Carboplatin or Cisplatin) Followed by Pembrolizumab and Maintenance Olaparib vs Maintenance Pemetrexed in the First-Line Treatment of Participants With Metastatic Non-squamous Non-Small-Cell Lung Cancer (NSCLC)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03976323
• Other study ID #: 7339-006
• Secondary ID: MK-7339-006KEYLY
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: June 28, 2019
• Est. completion date: January 13, 2025

Study information

• Verified date: June 2024
• Source: Merck Sharp & Dohme LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The current study will compare pembrolizumab (MK-3475) plus maintenance olaparib, vs pembrolizumab plus maintenance pemetrexed for the treatment of nonsquamous NSCLC. The study's 2 primary hypotheses are: 1. Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance pemetrexed with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) by blinded independent clinical review (BICR) and 2. Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance pemetrexed with respect to overall survival (OS).

Description:

This study has 2 phases: an Induction Phase (4 Cycles) and a Maintenance Phase (Up to 31 cycles of pembrolizumab). In the Induction Phase, participants receive pembrolizumab plus pemetrexed plus platinum (carboplatin or cisplatin). In the Maintenance Phase, participants with a partial or complete disease response or with stable disease after completing four cycles of induction therapy and who meet eligibility criteria will be randomly assigned to receive pembrolizumab plus maintenance olaparib OR pembrolizumab plus maintenance pemetrexed. In the Maintenance Phase, participants receive pembrolizumab for up to 31 cycles plus maintenance olaparib OR maintenance pemetrexed until progressive disease (PD), intolerable toxicities, or physician decision.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 672
• Est. completion date: January 13, 2025
• Est. primary completion date: February 7, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Have a histologically or cytologically confirmed diagnosis nonsquamous NSCLC.

2. Have stage IV nonsquamous NSCLC.

3. Have confirmation that epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or Proto-oncogene tyrosine-protein kinase (ROS1)-directed therapy is not indicated.

4. Have measurable disease based on RECIST 1.1.

5. Have provided archival tumor tissue sample or newly obtained core or incisional biopsy of a tumor lesion not previously irradiated. Note: Adequacy of biopsy specimen for the above analyses must be confirmed by the central laboratory before the participant can start the induction phase. Submission of another tumor specimen may be required prior to enrolling the participant, if adequate tumor tissue was not provided the first time.

6. Have a life expectancy of at least 3 months.

7. Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status assessed within 7 days prior to the administration of study intervention.

8. Have not received prior systemic treatment for their advanced/metastatic NSCLC.

9. Have adequate organ function.

10. Male and female participants who are not pregnant and of childbearing potential must follow contraceptive guidance during the treatment period and for 180 days afterwards.

11. Male participants must refrain from donating sperm, and female participants must refrain from donating eggs to others or freeze/store for her own use during the treatment period and for 180 days afterwards.

Exclusion Criteria:

1. Has predominantly squamous cell histology NSCLC.

2. Has a known additional malignancy that is progressing or has progressed within the past 3 years requiring active treatment.

3. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.

4. Has a severe hypersensitivity (=Grade 3) to pembrolizumab and/or any of its excipients.

5. Has a known hypersensitivity to any components or excipients of cisplatin, carboplatin, pemetrexed, or olaparib.

6. Has an active autoimmune disease that has required systemic treatment in past 2 years.

7. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy.

8. Has a known history of human immunodeficiency virus (HIV) infection, a known history of hepatitis B infection, or known active hepatitis C virus infection.

9. Has interstitial lung disease, or history of pneumonitis requiring systemic steroids for treatment.

10. Has received prior therapy with olaparib or with any other polyadenosine 5' diphosphoribose (polyADP ribose) polymerization (PARP) inhibitor.

11. Has received prior therapy with an agent directed to programmed cell death ligand 1 (PD-L1), anti PD-L2, or directed to a stimulatory or co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), OX-40, CD137).

12. Has myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with features suggestive of MDS/AML.

13. Has history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.

14. Has completed palliative radiotherapy within 7 days of the first dose. Participants must have recovered from all radiation-related toxicities and not require corticosteroids.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Carcinoma, Non-squamous Non-small-cell Lung
• Lung Neoplasms

Intervention

Biological:
• Pembrolizumab
IV infusion

Drug:
• Pemetrexed
IV infusion
• Carboplatin
IV infusion
• Cisplatin
IV infusion
• Olaparib
Tablets

Locations

Country	Name	City	State
Argentina	Hospital Italiano Regional del Sur ( Site 0509)	Bahia Blanca	Buenos Aires
Argentina	Hospital Britanico de Buenos Aires ( Site 0500)	Buenos Aires	Caba
Argentina	Hospital Italiano de Buenos Aires ( Site 0511)	Buenos Aires
Argentina	Clínica Universitaria Reina Fabiola ( Site 0505)	Cordoba
Argentina	Instituto Medico Rio Cuarto ( Site 0501)	Rio Cuarto	Cordoba
Argentina	Centro Oncológico de Rosario ( Site 0507)	Rosario	Santa Fe
Argentina	Centro Medico San Roque ( Site 0506)	San Miguel de Tucuman	Tucuman
Argentina	Sanatorio Privado San Geronimo S.R.L ( Site 0510)	Santa Fe
Australia	Monash Cancer Centre ( Site 1205)	Clayton	Victoria
Australia	Liverpool Hospital ( Site 1201)	Liverpool	New South Wales
Australia	Townsville General Hospital ( Site 1202)	Townsville	Queensland
Australia	Southern Medical Day Care Centre ( Site 1200)	Wollongong	New South Wales
Austria	Innsbruck LKH ( Site 1302)	Innsbruck	Tirol
Austria	Ordensklinikum Linz GmbH Elisabethinen ( Site 1307)	Linz	Oberosterreich
Austria	Social Medical Center - Otto Wagner Hospital ( Site 1301)	Vienna	Wien
Austria	Klinikum Wels-Grieskirchen ( Site 1304)	Wels	Oberosterreich
Austria	Krankenhaus Nord - Klinik Floridsdorf ( Site 1300)	Wien
Brazil	Oncologica do Brasil ( Site 0210)	Belem	Para
Brazil	Hospital Tacchini ( Site 0208)	Bento Goncalves	Rio Grande Do Sul
Brazil	YNOVA Pesquisa Clinica ( Site 0215)	Florianopolis	Santa Catarina
Brazil	Instituto do Cancer do Ceara ( Site 0201)	Fortaleza	Ceara
Brazil	Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral ( Site 0202)	Itajai	Santa Catarina
Brazil	Centro de Hematologia e Oncologia ( Site 0205)	Joinville	Santa Catarina
Brazil	Irmandade da Santa Casa de Misericordia de Porto Alegre ( Site 0209)	Porto Alegre	Rio Grande Do Sul
Brazil	Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0203)	Rio de Janeiro
Brazil	Hospital Sao Rafael ( Site 0212)	Salvador	Bahia
Brazil	Saint Gallen Instituto de Oncologia ( Site 0206)	Santa Cruz do Sul	Rio Grande Do Sul
Brazil	Hospital de Base de Sao Jose de Rio Preto ( Site 0204)	Sao Jose Rio Preto	Sao Paulo
Brazil	Hospital Paulistano - Amil Clinical Research ( Site 0207)	Sao Paulo
Brazil	Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0200)	Sao Paulo
Brazil	Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 0214)	Sao Paulo
Canada	CISSS de la Monteregie-Centre ( Site 0114)	Greenfield Park	Quebec
Canada	Queen Elizabeth II Health Sciences Centre ( Site 0107)	Halifax	Nova Scotia
Canada	Grand River Hospital ( Site 0117)	Kitchener	Ontario
Canada	Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0105)	Montreal	Quebec
Canada	CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 0110)	Montreal	Quebec
Canada	Stronach Regional Cancer Centre ( Site 0101)	Newmarket	Ontario
Canada	Lions Gate Hospital ( Site 0106)	North Vancouver	British Columbia
Canada	Centre de Sante et des Services Sociaux de Rimouski-Neigette ( Site 0104)	Rimouski	Quebec
Canada	CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0103)	Sherbrooke	Quebec
Canada	Health Sciences North Research Institute ( Site 0115)	Sudbury	Ontario
Canada	BC Cancer - Victoria ( Site 0109)	Victoria	British Columbia
Colombia	Clinica de la Costa Ltda. ( Site 0608)	Barranquilla	Atlantico
Colombia	Administradora Country S.A. ( Site 0603)	Bogota	Distrito Capital De Bogota
Colombia	Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 0601)	Bogota	Distrito Capital De Bogota
Colombia	Fundacion Colombiana de Cancerologia Clinica Vida ( Site 0604)	Medellin	Antioquia
France	CHU Angers ( Site 1405)	Angers	Maine-et-Loire
France	CHU Caen ( Site 1406)	Caen	Calvados
France	Centre Hospitalier De Chauny ( Site 1411)	Chauny	Aisne
France	Centre Jean Perrin ( Site 1407)	Clermont Ferrand	Puy-de-Dome
France	Centre Hospitalier de Pau ( Site 1412)	Pau	Pyrenees-Atlantiques
France	CHU de Rouen ( Site 1403)	Rouen	Seine-Maritime
France	Hopital d'Instruction des Armees Begin ( Site 1413)	Saint-Mande	Val-de-Marne
France	Institut De Cancerologie De Lorraine ( Site 1409)	Vandoeuvre les Nancy	Meurthe-et-Moselle
France	Hopital Robert Schuman ( Site 1402)	Vantoux	Moselle
Germany	Studienzentrum Aschaffenburg ( Site 1525)	Aschaffenburg	Bayern
Germany	Universitaetsklinikum Bonn ( Site 1524)	Bonn	Nordrhein-Westfalen
Germany	Helios Klinikum Erfurt GmbH ( Site 1502)	Erfurt	Thuringen
Germany	Kliniken Essen Mitte ( Site 1517)	Essen	Nordrhein-Westfalen
Germany	Universitaetsklinikum Frankfurt ( Site 1513)	Frankfurt	Hessen
Germany	Universitaetsmedizin Goettingen ( Site 1507)	Goettingen	Niedersachsen
Germany	Katholisches Marienkrankenhaus gGmbH ( Site 1522)	Hamburg
Germany	Pneumologische Lehrklinik Universitaet Goettingen ( Site 1501)	Immenhausen	Hessen
Germany	InVo-Institut fuer Versorgungsforschung in der Onkologie ( Site 1514)	Koblenz	Rheinland-Pfalz
Germany	Klinikum Bogenhausen Staedt. Klinikum Muenchen GmbH ( Site 1523)	Muenchen	Bayern
Germany	Klinikum der LMU ( Site 1500)	Munich	Bayern
Germany	Universitaetsklinikum Regensburg ( Site 1512)	Regensburg	Bayern
Germany	Klinikum Wuerzburg Mitte gGmbH ( Site 1509)	Wuerzburg	Bayern
Japan	National Hospital Organization Kyushu Medical Center ( Site 0805)	Fukuoka
Japan	Kansai Medical University Hospital ( Site 0804)	Hirakata	Osaka
Japan	Kanazawa University Hospital ( Site 0811)	Kanazawa	Ishikawa
Japan	National Cancer Center Hospital East ( Site 0801)	Kashiwa	Chiba
Japan	Aichi Cancer Center Hospital ( Site 0803)	Nagoya	Aichi
Japan	National Hospital Organization Nagoya Medical Center ( Site 0806)	Nagoya	Aichi
Japan	Niigata Cancer Center Hospital ( Site 0808)	Niigata
Japan	Okayama University Hospital ( Site 0810)	Okayama
Japan	Osaka International Cancer Institute ( Site 0809)	Osaka
Japan	National Hospital Organization Kinki-chuo Chest Medical Center ( Site 0813)	Sakai	Osaka
Japan	Sendai Kousei Hospital ( Site 0812)	Sendai	Miyagi
Japan	Shizuoka Cancer Center Hospital and Research Institute ( Site 0802)	Sunto-gun	Shizuoka
Japan	The Cancer Institute Hospital of JFCR ( Site 0800)	Tokyo
Japan	Kanagawa Cancer Center ( Site 0807)	Yokohama	Kanagawa
Korea, Republic of	Chungbuk National University Hospital ( Site 1002)	Cheongju si	Chungbuk
Korea, Republic of	National Cancer Center ( Site 1006)	Goyang-si	Kyonggi-do
Korea, Republic of	Gyeongsang National University Hospital ( Site 1005)	Jinju	Kyongsangnam-do
Korea, Republic of	Korea University Guro Hospital ( Site 1008)	Seoul
Korea, Republic of	Seoul National University Hospital ( Site 1000)	Seoul
Korea, Republic of	Asan Medical Center ( Site 1007)	Songpa-gu	Seoul
Korea, Republic of	Ajou University Hospital ( Site 1004)	Suwon	Kyonggi-do
Korea, Republic of	The Catholic University of Korea St. Vincent s Hospital ( Site 1003)	Suwon	Kyonggi-do
New Zealand	MidCentral DHB Palmerston North Hospital ( Site 1102)	Palmerston North	Manawatu-Wanganui
New Zealand	Capital & Coast District Health Board - Wellington Hospital ( Site 1101)	Wellington
Poland	Przychodnia Lekarska Komed ( Site 2416)	Konin	Wielkopolskie
Poland	Krakowski Szpital Specjalistyczny im Jana Pawla II ( Site 2420)	Krakow	Malopolskie
Poland	Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc ( Site 2417)	Olsztyn	Warminsko-mazurskie
Poland	MED-POLONIA Sp. z o.o. ( Site 2419)	Poznan	Wielkopolskie
Poland	Szpital Rejonowy im. dr Jozefa Rostka ( Site 2402)	Raciborz	Slaskie
Poland	Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (	Warszawa	Mazowieckie
Poland	Wielospecjalistyczny Szpital SPZOZ w Zgorzelcu ( Site 2404)	Zgorzelec	Dolnoslaskie
Romania	Spitalul PDR Medlife ( Site 2509)	Brasov
Romania	S.C.Focus Lab Plus S.R.L ( Site 2502)	Bucuresti
Romania	Cardiomed SRL Cluj-Napoca ( Site 2504)	Cluj Napoca	Cluj
Romania	S.C. Radiotherapy Center Cluj S.R.L ( Site 2507)	Cluj-Napoca	Cluj
Romania	Spitalul Clinic Judetean De Urgenta Constanta ( Site 2501)	Constanta
Romania	S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 2508)	Craiova	Dolj
Romania	Policlinica Oncomed SRL ( Site 2505)	Timisoara	Timis
Russian Federation	Moscow Regional Oncological Dispensary ( Site 2028)	Balashikha	Moskovskaya Oblast
Russian Federation	Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 2021)	Kazan	Tatarstan, Respublika
Russian Federation	First Moscow State Medical University n.a. I.M.Sechenov ( Site 2024)	Moscow	Moskva
Russian Federation	FSAI Treatment and Rehabilitation Centre of the MoH and SD of RF ( Site 2006)	Moscow	Moskva
Russian Federation	Moscow Research Oncology Institute named after P.A. Hertsen ( Site 2009)	Moscow	Moskva
Russian Federation	Russian Oncological Research Center n.a. N.N.Blokhin of MoH ( Site 2000)	Moscow	Moskva
Russian Federation	Nizhniy Novgorod Region Oncology Dispensary ( Site 2026)	Nizhniy Novgorod	Nizhegorodskaya Oblast
Russian Federation	Budgetary Healthcare Institution of Omsk Region Clinical Oncology Dispensary-Chemotherapy #1 ( Site	Omsk	Omskaya Oblast
Russian Federation	National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 2004)	Saint Petersburg	Sankt-Peterburg
Russian Federation	SBHI Leningrad Regional Clinical Hospital ( Site 2002)	Saint Petersburg	Leningradskaya Oblast
Russian Federation	SPb Central Clinical Railway Hospital ( Site 2003)	Saint Petersburg	Sankt-Peterburg
Russian Federation	SPb SBHI City Clinical Oncological Dispensary ( Site 2001)	Saint Petersburg	Sankt-Peterburg
Russian Federation	SBHI Samara Regional Clinical Oncology Dispensary ( Site 2016)	Samara	Samarskaya Oblast
Spain	Hospital del Mar ( Site 1702)	Barcelona
Spain	Hospital Universitario Quiron Madrid ( Site 1701)	Pozuelo de Alarcon	Madrid
Spain	Hospital Universitario Nuestra Senora de Valme ( Site 1703)	Sevilla
Spain	Hospital Clinico Universitario de Valencia ( Site 1706)	Valencia	Valenciana, Comunitat
Spain	Hospital Clinico Lozano Blesa ( Site 1700)	Zaragoza
Taiwan	Chang Gung Medical Foundation. Kaohsiung Branch ( Site 0907)	Kaohsiung
Taiwan	China Medical University Hospital ( Site 0904)	Taichung
Taiwan	National Cheng Kung University Hospital ( Site 0905)	Tainan
Taiwan	Mackay Memorial Hospital ( Site 0902)	Taipei
Taiwan	National Taiwan University Hospital ( Site 0900)	Taipei
Taiwan	Chang Gung Medical Foundation.Linkou Branch ( Site 0903)	Taoyuan
Turkey	Baskent Unv. Adana Uyg. ve Arast. Hastanesi ( Site 2101)	Adana
Turkey	Ankara Sehir Hastanesi ( Site 2105)	Ankara
Turkey	Gazi Universitesi Tip Fakultesi ( Site 2104)	Ankara
Turkey	Bezmialem Vakif Univ. Tip Fakultesi Hastanesi Tibbi Onkoloji Bolumu ( Site 2107)	Istanbul
Turkey	Göztepe Prof. Dr. Süleyman Yalçin Sehir Hastanesi-oncology ( Site 2103)	Istanbul
Turkey	Ege Universitesi Tip Fakultesi ( Site 2109)	Izmir
Turkey	Erciyes Universitesi Tip Fakultesi ( Site 2108)	Kayseri
Turkey	Samsun Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi ( Site 2106)	Samsun
Turkey	Namik Kemal Universitesi Tip Fakultesi ( Site 2100)	Tekirdag	Tekirdas
Ukraine	Cherkasy Regional Oncology Dispensary ( Site 2211)	Cherkasy	Cherkaska Oblast
Ukraine	City Clinical Hosp.4 of DCC ( Site 2201)	Dnipro	Dnipropetrovska Oblast
Ukraine	MI Precarpathian Clinical Oncology Center ( Site 2204)	Ivano-Frankivsk	Ivano-Frankivska Oblast
Ukraine	Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 2212)	Kharkiv	Kharkivska Oblast
Ukraine	Regional Centre of Oncology-Thoracic organs ( Site 2205)	Kharkiv	Kharkivska Oblast
Ukraine	Medical Center Asklepion LLC ( Site 2234)	Khodosivka	Kyivska Oblast
Ukraine	PP PPC Acinus Medical and Diagnostic Centre ( Site 2209)	Kropyvnitskiy	Kirovohradska Oblast
Ukraine	Kyiv City Clinical Oncology Centre ( Site 2210)	Kyiv
Ukraine	Medical and Diagnostic Centre LLC Dobryi Prognoz ( Site 2213)	Kyiv	Kyivska Oblast
Ukraine	Medical Center Verum ( Site 2230)	Kyiv
Ukraine	MI Odessa Regional Oncological Centre ( Site 2208)	Odesa	Odeska Oblast
Ukraine	Central City Clinical Hospital ( Site 2207)	Uzhgorod	Zakarpatska Oblast
United Kingdom	Birmingham Heartlands Hospital ( Site 1910)	Birmingham
United Kingdom	West Suffolk Hospitals NHS Trust ( Site 1919)	Bury Saint Edmunds	Suffolk
United Kingdom	Colchester General Hospital ( Site 1911)	Colchester	Worcestershire
United Kingdom	Western General Hospital, Edinburgh ( Site 1924)	Edinburg
United Kingdom	Barts Health NHS Trust - St Bartholomew s Hospital ( Site 1923)	London	London, City Of
United Kingdom	Chelsea and Westminster Hospital ( Site 1901)	London	London, City Of
United Kingdom	Singleton Hospital ( Site 1909)	Swansea
United States	Medstar Good Samaritan Hospital ( Site 0040)	Baltimore	Maryland
United States	Frontier Oncology ( Site 0080)	Billings	Montana
United States	Alabama Oncology Bruno Cancer Center ( Site 0001)	Birmingham	Alabama
United States	Boca Raton Regional Hospital ( Site 0018)	Boca Raton	Florida
United States	Bozeman Health Deaconness Cancer Center ( Site 0046)	Bozeman	Montana
United States	Disney Family Cancer Center ( Site 0005)	Burbank	California
United States	Waverly Hematology Oncology ( Site 0081)	Cary	North Carolina
United States	Mount Sinai Hospital Medical Center ( Site 0032)	Chicago	Illinois
United States	Columbus Regional Research Institute ( Site 0098)	Columbus	Georgia
United States	Barbara Ann Karmanos Cancer Institute ( Site 0041)	Detroit	Michigan
United States	Hattiesburg Clinic ( Site 0045)	Hattiesburg	Mississippi
United States	Thompson Cancer Survival Center ( Site 2812)	Knoxville	Tennessee
United States	University of Tennessee Medical Center Knoxville ( Site 0060)	Knoxville	Tennessee
United States	Methodists Hospitals/Premier Oncology Hematology Associates ( Site 0036)	Merrillville	Indiana
United States	Northwest Alabama Cancer Center, PC ( Site 0002)	Muscle Shoals	Alabama
United States	Mid-Florida Cancer Centers ( Site 0022)	Orange City	Florida
United States	Oncology of Northshore ( Site 0033)	Rolling Meadows	Illinois
United States	Cancer Care Northwest ( Site 0071)	Spokane Valley	Washington
United States	Moffitt Cancer Center ( Site 0024)	Tampa	Florida
United States	Renovatio Clinical ( Site 0062)	The Woodlands	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme LLC

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Brazil,  Canada,  Colombia,  France,  Germany,  Japan,  Korea, Republic of,  New Zealand,  Poland,  Romania,  Russian Federation,  Spain,  Taiwan,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)	Progression-free survival is the time from the date of randomization until either documented disease progression or death due to any cause, whichever occurs first.	Up to approximately 3 years
Primary	Overall Survival (OS)	Overall survival is the time from the date of randomization to death due to any cause.	Up to approximately 5 years
Secondary	Number of Participants Experiencing an Adverse Event (AE)	An adverse event (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 5 years
Secondary	Number of Participants Discontinuing Study Treatment Due to Adverse Event (AE)	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 5 years
Secondary	Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status / Quality of Life (Items 29 and 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 (at randomization) and Week 18 post-randomization
Secondary	Change from Baseline 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 QLQ-C30 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 (at randomization) and Week 18 post-randomization
Secondary	Change from Baseline 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 QLQ-C30 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 (at randomization) and Week 18 post-randomization
Secondary	Change from Baseline 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 (at randomization) and Week 18 post-randomization
Secondary	Change from Baseline 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 (at randomization) and Week 18 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 is 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 5 years
Secondary	Time to True Deterioration (TTD) 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 QLQ-C30 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 is 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 QLQ-LC13 cough (Item 1) scale score.	Up to approximately 5 years
Secondary	Time to True Deterioration (TTD) 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 QLQ-C30 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 is 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 5 years
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 is 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 5 years
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 is 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 5 years

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