Clinical trial NCT03976362: A Study of Pembrolizumab (MK-3475) With or Without Maintenance Olaparib in First-line Metastatic Squamous Non-small Cell Lung Cancer (NSCLC, MK-7339-008/KEYLYNK-008)
Official title: A Phase 3 Study of Pembrolizumab in Combination With Carboplatin/Taxane (Paclitaxel or Nab-paclitaxel) Followed by Pembrolizumab With or Without Maintenance Olaparib in the First-line Treatment of Metastatic Squamous Non-small Cell Lung Cancer (NSCLC)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Carcinoma, Squamous Cell, Non-small-cell Lung
Keywords: PD-1
PD L1
PD L2
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2019-06-06
Enrollment: 851
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The current study will compare pembrolizumab (MK-3475) plus maintenance olaparib, vs. pembrolizumab plus maintenance olaparib placebo for the treatment of squamous NSCLC. The study's 2 primary hypotheses are:

1. Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance olaparib placebo with respect to progression-free survival (PFS) per RECIST 1.1 by blinded independent clinical review (BICR).
2. Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance olaparib placebo with respect to overall survival (OS).

As of Amendment 07, there will be no further analyses for OS and patient-reported outcome assessments.

Detailed 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 carboplatin plus a taxane (paclitaxel or nab-paclitaxel). 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 olaparib placebo. In the Maintenance Phase, participants randomly assigned to receive pembrolizumab for up to 31 cycles plus maintenance olaparib OR maintenance olaparib placebo until centrally verified progressive disease (PD), intolerable toxicities, or physician decision.

As of Amendment 07, participants actively taking placebo will discontinue taking the placebo intervention and continue in the study.

Eligibility criteria: Inclusion Criteria:

1. Have a histologically or cytologically confirmed diagnosis squamous NSCLC.
2. Have Stage IV squamous NSCLC.
3. Have measurable disease based on RECIST 1.1.
4. Have not received prior systemic treatment for their advanced/metastatic NSCLC.
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 receive study intervention(s). 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 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
7. Have a life expectancy of at least 3 months.
8. Has adequate organ function.
9. 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.
10. Male participants must refrain from donating sperm during the treatment period and for 180 days afterwards.

Exclusion Criteria:

1. Has non-squamous 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 metastases and/or carcinomatous meningitis.
4. Has a known hypersensitivity to any components or excipients of carboplatin, paclitaxel or nab-paclitaxel, or olaparib.
5. Has a severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
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.

Primary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: Up to approximately 39 months
measure: Overall Survival (OS)
timeFrame: Up to approximately 46 months
Secondary outcomes:
measure: Number of Participants With One or More Adverse Events (AEs)
timeFrame: Up to approximately 4 years
measure: Number of Participants Who Discontinued Study Intervention Due to an AE
timeFrame: Up to approximately 4 years
measure: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (GHS)/ Quality of Life (QoL) (Items 29 and 30) Combined Scale Score
timeFrame: Baseline and Week 24
measure: Time to True Deterioration (TTD) in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (GHS)/Quality of Life (QoL) (Items 29 and 30) Scale Score
timeFrame: Up to approximately 2 years
measure: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Cough (Item 1) Scale Score
timeFrame: Baseline and Week 24
measure: Time to True Deterioration (TTD) in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Cough (Item 1) Scale Score
timeFrame: Up to approximately 2 years
measure: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Chest Pain (Item 10) Scale Score
timeFrame: Baseline and Week 24
measure: Time to True Deterioration (TTD) in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Chest Pain (Item 10) Scale Score
timeFrame: Up to approximately 2 years
measure: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Dyspnea (Item 8) Scale Score
timeFrame: Baseline and Week 24
measure: Time to True Deterioration (TTD) in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Dyspnea (Item 8) Scale Score
timeFrame: Up to approximately 2 years
measure: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Physical Functioning (Items 1 to 5) Scale Score
timeFrame: Baseline and Week 24
measure: Time to True Deterioration (TTD) in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Physical Functioning (Items 1 to 5) Scale Score
timeFrame: Up to approximately 2 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Oncology Bruno Cancer Center ( Site 0001)
state: Alabama
city: Burbank
country: United States
facility: Disney Family Cancer Center ( Site 0005)
state: California
city: Boca Raton
country: United States
facility: Boca Raton Regional Hospital ( Site 0018)
state: Florida
city: Orange City
country: United States
facility: Mid-Florida Cancer Centers ( Site 0022)
state: Florida
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute ( Site 0024)
state: Florida
city: Columbus
country: United States
facility: Columbus Regional Research Institute ( Site 0099)
state: Georgia
city: Chicago
country: United States
facility: Mount Sinai Hospital Medical Center ( Site 0035)
state: Illinois
city: Rolling Meadows
country: United States
facility: Oncology of Northshore ( Site 0036)
state: Illinois
city: Merrillville
country: United States
facility: Methodists Hospitals/Premier Oncology Hematology Associates ( Site 0039)
state: Indiana
city: Baltimore
country: United States
facility: MedStar Franklin Square Medical Center ( Site 0044)
state: Maryland
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute ( Site 0046)
state: Michigan
city: Hattiesburg
country: United States
facility: Hattiesburg Clinic ( Site 0051)
state: Mississippi
city: Billings
country: United States
facility: Frontier Oncology ( Site 0052)
state: Montana
city: Bozeman
country: United States
facility: Bozeman Health Deaconness Cancer Center ( Site 0053)
state: Montana
city: Cary
country: United States
facility: Waverly Hematology Oncology ( Site 0054)
state: North Carolina
city: Knoxville
country: United States
facility: Thompson Cancer Survival Center ( Site 2812)
state: Tennessee
city: The Woodlands
country: United States
facility: Renovatio Clinical ( Site 0074)
state: Texas
city: Spokane Valley
country: United States
facility: Cancer Care Northwest ( Site 0083)
state: Washington
city: Bahia Blanca
country: Argentina
facility: Hospital Italiano Regional del Sur ( Site 0509)
state: Buenos Aires
city: Mar del Plata
country: Argentina
facility: Instituto de Investigaciones Clinicas Mar del Plata ( Site 0516)
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Hospital Britanico de Buenos Aires ( Site 0500)
state: Caba
city: Rio Cuarto
country: Argentina
facility: Instituto Medico Rio Cuarto ( Site 0501)
state: Cordoba
city: Rosario
country: Argentina
facility: Sanatorio Parque ( Site 0515)
state: Santa Fe
city: Rosario
country: Argentina
facility: Centro Oncológico de Rosario ( Site 0507)
state: Santa Fe
city: San Miguel de Tucuman
country: Argentina
facility: Centro Medico San Roque ( Site 0506)
state: Tucuman
city: Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires ( Site 0511)
city: Cordoba
country: Argentina
facility: Clínica Universitaria Reina Fabiola ( Site 0505)
city: Santa Fe
country: Argentina
facility: Sanatorio Privado San Geronimo S.R.L ( Site 0510)
city: Liverpool
country: Australia
facility: Liverpool Hospital ( Site 1201)
state: New South Wales
city: Wollongong
country: Australia
facility: Southern Medical Day Care Centre ( Site 1200)
state: New South Wales
city: Townsville
country: Australia
facility: Townsville General Hospital ( Site 1202)
state: Queensland
city: Clayton
country: Australia
facility: Monash Cancer Centre ( Site 1205)
state: Victoria
city: Linz
country: Austria
facility: Ordensklinikum Linz GmbH Elisabethinen ( Site 1307)
state: Oberosterreich
city: Wels
country: Austria
facility: Klinikum Wels-Grieskirchen ( Site 1304)
state: Oberosterreich
city: Innsbruck
country: Austria
facility: Innsbruck LKH ( Site 1302)
state: Tirol
city: Vienna
country: Austria
facility: Social Medical Center - Otto Wagner Hospital ( Site 1301)
state: Wien
city: Wien
country: Austria
facility: Krankenhaus Nord - Klinik Floridsdorf ( Site 1300)
city: Salvador - BA
country: Brazil
facility: Hospital Sao Rafael ( Site 0258)
state: Bahia
city: Fortaleza
country: Brazil
facility: Instituto do Cancer do Ceara ( Site 0251)
state: Ceara
city: Belem
country: Brazil
facility: Oncologica do Brasil ( Site 0256)
state: Para
city: Bento Goncalves
country: Brazil
facility: Hospital Tacchini ( Site 0265)
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Irmandade da Santa Casa de Misericordia de Porto Alegre ( Site 0255)
state: Rio Grande Do Sul
city: Itajai
country: Brazil
facility: Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral ( Site 0252)
state: Santa Catarina
city: Sao Jose Rio Preto
country: Brazil
facility: Hospital de Base de Sao Jose de Rio Preto ( Site 0254)
state: Sao Paulo
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0253)
city: Sao Paulo
country: Brazil
facility: Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0250)
city: Sao Paulo
country: Brazil
facility: Hospital Paulistano - Amil Clinical Research ( Site 0263)
city: Sao Paulo
country: Brazil
facility: Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 0260)
city: Halifax
country: Canada
facility: Nova Scotia Health Authority ( Site 0103)
state: Nova Scotia
city: Hamilton
country: Canada
facility: Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0107)
state: Ontario
city: Kingston
country: Canada
facility: Kingston Health Sciences Centre ( Site 0102)
state: Ontario
city: Newmarket
country: Canada
facility: Stronach Regional Cancer Centre ( Site 0100)
state: Ontario
city: Greenfield Park
country: Canada
facility: CISSS de la Monteregie-Centre ( Site 0101)
state: Quebec
city: Laval
country: Canada
facility: Hopital Cite de la Sante de Laval ( Site 0105)
state: Quebec
city: Montreal
country: Canada
facility: CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 0110)
state: Quebec
city: Trois-Rivieres
country: Canada
facility: CIUSSS de la Mauricie et du Centre du Quebec ( Site 0106)
state: Quebec
city: Chauny
country: France
facility: Centre Hospitalier De Chauny ( Site 1411)
state: Aisne
city: Caen
country: France
facility: CHU Caen ( Site 1406)
state: Calvados
city: Angers
country: France
facility: CHU Angers ( Site 1405)
state: Maine-et-Loire
city: Vandoeuvre les Nancy
country: France
facility: Institut De Cancerologie De Lorraine ( Site 1409)
state: Meurthe-et-Moselle
city: Vantoux
country: France
facility: Hopital Robert Schuman ( Site 1402)
state: Moselle
city: Clermont Ferrand
country: France
facility: Centre Jean Perrin ( Site 1407)
state: Puy-de-Dome
city: Pau
country: France
facility: Centre Hospitalier de Pau ( Site 1412)
state: Pyrenees-Atlantiques
city: Rouen
country: France
facility: CHU de Rouen ( Site 1403)
state: Seine-Maritime
city: Saint-Mande
country: France
facility: Hopital d'Instruction des Armees Begin ( Site 1413)
state: Val-de-Marne
city: Aschaffenburg
country: Germany
facility: Studienzentrum Aschaffenburg ( Site 1575)
state: Bayern
city: Muenchen
country: Germany
facility: Klinikum Bogenhausen Staedt. Klinikum Muenchen GmbH ( Site 1573)
state: Bayern
city: Munich
country: Germany
facility: Klinikum der LMU ( Site 1550)
state: Bayern
city: Regensburg
country: Germany
facility: Universitaetsklinikum Regensburg ( Site 1562)
state: Bayern
city: Wuerzburg
country: Germany
facility: Klinikum Wuerzburg Mitte gGmbH ( Site 1559)
state: Bayern
city: Frankfurt
country: Germany
facility: Universitaetsklinikum Frankfurt ( Site 1563)
state: Hessen
city: Immenhausen
country: Germany
facility: Pneumologische Lehrklinik Universitaet Goettingen ( Site 1551)
state: Hessen
city: Goettingen
country: Germany
facility: Universitaetsmedizin Goettingen ( Site 1557)
state: Niedersachsen
city: Bonn
country: Germany
facility: Universitaetsklinikum Bonn ( Site 1574)
state: Nordrhein-Westfalen
city: Essen
country: Germany
facility: Kliniken Essen Mitte ( Site 1567)
state: Nordrhein-Westfalen
city: Koblenz
country: Germany
facility: InVo-Institut fuer Versorgungsforschung in der Onkologie ( Site 1564)
state: Rheinland-Pfalz
city: Erfurt
country: Germany
facility: Helios Klinikum Erfurt GmbH ( Site 1552)
state: Thuringen
city: Hamburg
country: Germany
facility: Katholisches Marienkrankenhaus gGmbH ( Site 1572)
city: Nagoya
country: Japan
facility: National Hospital Organization Nagoya Medical Center ( Site 0806)
state: Aichi
city: Nagoya
country: Japan
facility: Aichi Cancer Center Hospital ( Site 0803)
state: Aichi
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East ( Site 0801)
state: Chiba
city: Kurume
country: Japan
facility: Kurume University Hospital ( Site 0814)
state: Fukuoka
city: Kanazawa
country: Japan
facility: Kanazawa University Hospital ( Site 0811)
state: Ishikawa
city: Yokohama
country: Japan
facility: Kanagawa Cancer Center ( Site 0807)
state: Kanagawa
city: Sendai
country: Japan
facility: Sendai Kousei Hospital ( Site 0812)
state: Miyagi
city: Hirakata
country: Japan
facility: Kansai Medical University Hospital ( Site 0804)
state: Osaka
city: Sakai
country: Japan
facility: National Hospital Organization Kinki-chuo Chest Medical Center ( Site 0813)
state: Osaka
city: Sunto-gun
country: Japan
facility: Shizuoka Cancer Center Hospital and Research Institute ( Site 0802)
state: Shizuoka
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Medical Center ( Site 0805)
city: Niigata
country: Japan
facility: Niigata Cancer Center Hospital ( Site 0808)
city: Okayama
country: Japan
facility: Okayama University Hospital ( Site 0810)
city: Osaka
country: Japan
facility: Osaka International Cancer Institute ( Site 0809)
city: Tokyo
country: Japan
facility: The Cancer Institute Hospital of JFCR ( Site 0800)
city: Cheongju si
country: Korea, Republic of
facility: Chungbuk National University Hospital ( Site 1002)
state: Chungbuk
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center ( Site 1006)
state: Kyonggi-do
city: Gyeonggi-do
country: Korea, Republic of
facility: The Catholic University of Korea St. Vincent s Hospital ( Site 1003)
state: Kyonggi-do
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital ( Site 1004)
state: Kyonggi-do
city: Jinju
country: Korea, Republic of
facility: Gyeongsang National University Hospital ( Site 1005)
state: Kyongsangnam-do
city: Songpa-gu
country: Korea, Republic of
facility: Asan Medical Center ( Site 1007)
state: Seoul
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital ( Site 1000)
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System ( Site 1001)
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital ( Site 1008)
city: La Paz
country: Mexico
facility: Investigacion Onco Farmaceutica S de RL de CV ( Site 0300)
state: Baja California Sur
city: Guadalajara
country: Mexico
facility: Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0334)
state: Jalisco
city: Monterrey
country: Mexico
facility: Axis Heilsa S. de R.L. de C.V. ( Site 0301)
state: Nuevo Leon
city: Orizaba
country: Mexico
facility: CLIMERS Clinical Medical Research ( Site 0306)
state: Veracruz
city: Cdmx
country: Mexico
facility: Arke Estudios Clinicos ( Site 0333)
city: Veracruz
country: Mexico
facility: FAICIC Clinical Research ( Site 0303)
city: Palmerston North
country: New Zealand
facility: MidCentral DHB Palmerston North Hospital ( Site 1102)
state: Manawatu-Wanganui
city: Wellington
country: New Zealand
facility: Capital & Coast District Health Board - Wellington Hospital ( Site 1101)
city: Olsztyn
country: Poland
facility: Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc ( Site 2417)
state: Dolnoslaskie
city: Zgorzelec
country: Poland
facility: Wielospecjalistyczny Szpital SPZOZ w Zgorzelcu ( Site 2404)
state: Dolnoslaskie
city: Krakow
country: Poland
facility: Krakowski Szpital Specjalistyczny im Jana Pawla II ( Site 2420)
state: Malopolskie
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (
state: Mazowieckie
city: Raciborz
country: Poland
facility: Szpital Rejonowy im. dr Jozefa Rostka ( Site 2402)
state: Slaskie
city: Konin
country: Poland
facility: Przychodnia Lekarska Komed ( Site 2416)
state: Wielkopolskie
city: Poznan
country: Poland
facility: MED-POLONIA Sp. z o.o. ( Site 2419)
state: Wielkopolskie
city: Cluj Napoca
country: Romania
facility: Cardiomed SRL Cluj-Napoca ( Site 2504)
state: Cluj
city: Cluj-Napoca
country: Romania
facility: S.C. Radiotherapy Center Cluj S.R.L ( Site 2507)
state: Cluj
city: Craiova
country: Romania
facility: S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 2508)
state: Dolj
city: Timisoara
country: Romania
facility: Policlinica Oncomed SRL ( Site 2505)
state: Timis
city: Bucuresti
country: Romania
facility: S.C.Focus Lab Plus S.R.L ( Site 2502)
city: Constanta
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Sf Apostol Andrei ( Site 2501)
city: Balashikha
country: Russian Federation
facility: Moscow Regional Oncological Dispensary ( Site 2028)
state: Moskovskaya Oblast
city: Moscow
country: Russian Federation
facility: Russian Oncological Research Center n.a. N.N.Blokhin of MoH ( Site 2000)
state: Moskva
city: Moscow
country: Russian Federation
facility: First Moscow State Medical University n.a. I.M.Sechenov ( Site 2024)
state: Moskva
city: Moscow
country: Russian Federation
facility: Moscow Research Oncology Institute named after P.A. Hertsen ( Site 2009)
state: Moskva
city: Moscow
country: Russian Federation
facility: FSAI Treatment and Rehabilitation Centre of the MoH and SD of RF ( Site 2006)
state: Moskva
city: Nizhniy Novgorod
country: Russian Federation
facility: Nizhniy Novgorod Region Oncology Dispensary ( Site 2026)
state: Nizhegorodskaya Oblast
city: Omsk
country: Russian Federation
facility: Budgetary Healthcare Institution of Omsk Region Clinical Oncology Dispensary-Chemotherapy #1 ( Site
state: Omskaya Oblast
city: Samara
country: Russian Federation
facility: SBHI Samara Regional Clinical Oncology Dispensary ( Site 2016)
state: Samarskaya Oblast
city: Saint Petersburg
country: Russian Federation
facility: SBHI Leningrad Regional Clinical Hospital ( Site 2002)
state: Sankt-Peterburg
city: Saint Petersburg
country: Russian Federation
facility: SPb Central Clinical Railway Hospital ( Site 2003)
state: Sankt-Peterburg
city: Saint Petersburg
country: Russian Federation
facility: National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 2004)
state: Sankt-Peterburg
city: Saint Petersburg
country: Russian Federation
facility: SPb SBHI City Clinical Oncological Dispensary ( Site 2001)
state: Sankt-Peterburg
city: Kazan
country: Russian Federation
facility: Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 2021)
state: Tatarstan, Respublika
city: Hospitalet de Llobregat
country: Spain
facility: Hospital Duran i Reynals ( Site 1710)
state: Barcelona
city: Jaen
country: Spain
facility: Complejo Hospitalario de Jaen ( Site 1713)
state: La Coruna
city: Barcelona
country: Spain
facility: Hospital Sant Creu i Sant Pau ( Site 1711)
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre ( Site 1716)
city: Malaga
country: Spain
facility: Complejo Hospitalario de Malaga ( Site 1714)
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena ( Site 1712)
city: Kaohsiung
country: Taiwan
facility: Chang Gung Medical Foundation. Kaohsiung Branch ( Site 0907)
city: Taichung
country: Taiwan
facility: China Medical University Hospital ( Site 0904)
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital ( Site 0905)
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital ( Site 0900)
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital ( Site 0902)
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation.Linkou Branch ( Site 0903)
city: Tekirdag
country: Turkey
facility: Namik Kemal Universitesi Tip Fakultesi ( Site 2100)
state: Tekirdas
city: Adana
country: Turkey
facility: Baskent Unv. Adana Uyg. ve Arast. Hastanesi ( Site 2101)
city: Ankara
country: Turkey
facility: Gazi Universitesi Tip Fakultesi ( Site 2104)
city: Ankara
country: Turkey
facility: Ankara Sehir Hastanesi ( Site 2105)
city: Istanbul
country: Turkey
facility: Bezmialem Vakif Univ. Tıp Fakultesi Hastanesi Tibbi Onkoloji Bolumu ( Site 2107)
city: Istanbul
country: Turkey
facility: Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 2103)
city: Izmir
country: Turkey
facility: Ege Universitesi Tip Fakultesi ( Site 2109)
city: Kayseri
country: Turkey
facility: Erciyes Universitesi Tip Fakultesi ( Site 2108)
city: Samsun
country: Turkey
facility: Ondokuz Mays Üniversitesi Tp Fakültesi Hastanesi-Oncology ( Site 2106)
city: Cherkasy
country: Ukraine
facility: Cherkasy Regional Oncology Dispensary ( Site 2225)
state: Cherkaska Oblast
city: Dnipro
country: Ukraine
facility: City Clinical Hosp.4 of DCC ( Site 2215)
state: Dnipropetrovska Oblast
city: Ivano-Frankivsk
country: Ukraine
facility: MI Precarpathian Clinical Oncology Center ( Site 2218)
state: Ivano-Frankivska Oblast
city: Kharkiv
country: Ukraine
facility: Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 2226)
state: Kharkivska Oblast
city: Kharkiv
country: Ukraine
facility: Regional Centre of Oncology-Thoracic organs ( Site 2219)
state: Kharkivska Oblast
city: Kropyvnytskyi
country: Ukraine
facility: PP PPC Acinus Medical and Diagnostic Centre ( Site 2223)
state: Kirovohradska Oblast
city: Khodosivka
country: Ukraine
facility: Medical Center Asklepion LLC ( Site 2243)
state: Kyivska Oblast
city: Kyiv
country: Ukraine
facility: Kyiv City Clinical Oncology Centre ( Site 2224)
state: Kyivska Oblast
city: Kyiv
country: Ukraine
facility: Medical and Diagnostic Centre LLC Dobryi Prognoz ( Site 2227)
state: Kyivska Oblast
city: Odesa
country: Ukraine
facility: MI Odessa Regional Oncological Centre ( Site 2222)
state: Odeska Oblast
city: Uzhgorod
country: Ukraine
facility: Central City Clinical Hospital ( Site 2221)
state: Zakarpatska Oblast
city: Kyiv
country: Ukraine
facility: Medical Center Verum ( Site 2228)
city: Westcliff-on-Sea
country: United Kingdom
facility: Southend University Hospital NHS Foundation Trust ( Site 1913)
state: Essex
city: London
country: United Kingdom
facility: Barts Health NHS Trust - St Bartholomew s Hospital ( Site 1923)
state: London, City Of
city: London
country: United Kingdom
facility: Chelsea and Westminster Hospital ( Site 1901)
state: London, City Of
city: Newcastle-upon-Tyne
country: United Kingdom
facility: Newcastle Freeman Hospital ( Site 1902)
state: Newcastle Upon Tyne
city: Bury Saint Edmunds
country: United Kingdom
facility: West Suffolk Hospitals NHS Trust ( Site 1919)
state: Suffolk
city: Swansea
country: United Kingdom
facility: Singleton Hospital ( Site 1909)
state: Wales
city: Colchester
country: United Kingdom
facility: Colchester General Hospital ( Site 1911)
state: Worcestershire
city: Birmingham
country: United Kingdom
facility: Birmingham Heartlands Hospital ( Site 1910)
city: Edinburg
country: United Kingdom
facility: Western General Hospital, Edinburgh ( Site 1924)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Hochmair M, Schenker M, Cobo Dols M, Kim TM, Ozyilkan O, Smagina M, Leonova V, Kato T, Fedenko A, De Angelis F, Rittmeyer A, Gray JE, Greystoke A, Aggarwal H, Huang Q, Zhao B, Lara-Guerra H, Nadal E. Pembrolizumab With or Without Maintenance Olaparib for Metastatic Squamous NSCLC That Responded to First-Line Pembrolizumab Plus Chemotherapy. J Thorac Oncol. 2025 Feb;20(2):203-218. doi: 10.1016/j.jtho.2024.10.012. Epub 2024 Oct 28.