Clinical trial NCT03976375: Efficacy and Safety of Pembrolizumab (MK-3475) With Lenvatinib (E7080/MK-7902) vs. Docetaxel in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC) and Progressive Disease (PD) After Platinum Doublet Chemotherapy and Immunotherapy (MK-7902-008/E7080-G000-316/LEAP-008)
Official title: A Phase 3, Multicenter, Randomized, Open-label Trial to Compare the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Lenvatinib (E7080/MK-7902) Versus Docetaxel in Previously Treated Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) and Progressive Disease (PD) After Platinum Doublet Chemotherapy and Immunotherapy (LEAP-008)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Metastatic Non-Small Cell Lung Cancer
Keywords: programmed cell death 1 (PD-1, PD1)
programmed cell death-ligand 1 (PD-L1, PDL1)
programmed cell death-ligand 2 (PD-L2, PDL2)
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
Collaborators: name: Eisai Inc.
First posted: 2019-06-06
Enrollment: 422
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: This study will evaluate the efficacy and safety of pembrolizumab (MK-3475) with lenvatinib (E7080/MK-7902) vs. docetaxel in participants with metastatic non-small cell lung cancer (NSCLC) and progressive disease (PD) after platinum doublet chemotherapy and treatment with one prior anti-PD-1/PD-L1 monoclonal antibody (mAb). The primary hypotheses of this study are that pembrolizumab + lenvatinib (compared with docetaxel) prolongs: 1) overall survival (OS); and progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) based on blinded independent central review (BICR).


Eligibility criteria: Inclusion Criteria:

* Has a histologically or cytologically confirmed diagnosis of metastatic squamous or nonsquamous Non-Small Cell Lung Cancer (NSCLC) -Stage IV: M1a, M1b, M1c.
* Has progressive disease (PD) on treatment with one prior anti-programmed cell death 1 (PD-1)/programmed cell death ligand 1 (PD-L1) monoclonal antibody (mAb) administered either as monotherapy or in combination with other checkpoint inhibitors or other therapies.

  * Retreatment with the same anti-PD-L1/PD-L1 mAb is acceptable in the overall course of treatment
* Has PD during/after platinum doublet chemotherapy for metastatic disease.
* Has confirmation that EGFR-, ALK-, or ROS1-directed therapy is not indicated as primary therapy (documentation of absence of tumor-activating EGFR mutations \[eg, DEL19 or L858R\], and absence of ALK and ROS1 gene rearrangements OR presence of a K-ras mutation).
* Has submitted pre-study imaging that confirmed evidence of PD following initiation of an anti-PD-1/PD-L1 inhibitor.
* Has at least 1 measurable lesion by computerized tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, as determined by the local site assessment.
* Has provided tumor tissue for PD-L1 biomarker analysis from an archival sample (defined as: from initial diagnosis of NSCLC and prior to receiving immunotherapy \[antiPD-1/PD-L1\], from the primary lesion or a metastatic lesion).
* Has provided prior to allocation tissue from a newly obtained formalin-fixed sample from a new biopsy (defined as: after completion of immunotherapy \[anti-PD-1/PD-L1\] and before receiving a randomization number), of a tumor lesion not previously irradiated.
* Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before the first dose of study intervention but before randomization.
* Has a life expectancy of at least 3 months.
* Male participants receiving pembrolizumab ± lenvatinib or lenvatinib must agree to refrain from donating sperm, and either 1) be abstinent from heterosexual intercourse; or 2) follow contraceptive guidance during the treatment period or 7 days after the last dose of lenvatinib. Male participants receiving docetaxel agree to adhere to the same conditions during the treatment period and for ≥90 days after the last dose of study treatment.
* Female participants must not be pregnant, not be breastfeeding, and not be a woman of child-bearing potential (WOCBP). If a WOCBP, agrees to not donate eggs and either use contraception, or be abstinent from heterosexual intercourse during the treatment period and for ≥120 days after the last dose of pembrolizumab or 30 days after the last dose of lenvatinib, whichever occurs last. If a WOCBP receiving docetaxel, agrees to adhere to the same conditions during the treatment period and for ≥30 days after the last dose of study treatment.
* Has adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP ≤150/90 mm Hg and no change in antihypertensive medications within 1 week before randomization.
* If participant received major surgery or radiation therapy of \>30 Gy, they have recovered from the toxicity and/or complications from the intervention.
* Has adequate organ function.

Exclusion Criteria:

* Has received docetaxel as monotherapy or in combination with other therapies.
* Has received lenvatinib as monotherapy or in combination with an anti-PD-1/PD-L1 mAb.
* Has received: 1) radiotherapy within 2 weeks before the first dose of study treatment; or 2) lung radiation therapy \>30 Gy within 6 months before the first dose of study treatment.
* Has received a live vaccine within 30 days before the first dose of study treatment.
* Has clinically significant hemoptysis or tumor bleeding within 2 weeks before the first dose of study treatment.
* Has radiographic evidence of intratumoral cavitation, encasement, or invasion of a major blood vessel.
* Has clinically significant cardiovascular impairment within 12 months of the first dose of study treatment.
* Has a history of a gastrointestinal condition or procedure that may affect oral absorption of study treatment.
* Has a pre-existing ≥Grade 3 gastrointestinal or non-gastrointestinal fistula.
* Is currently participating in a clinical trial and receiving study therapy or participated in a study of an investigational agent within 4 weeks of the first dose of study treatment.
* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days before the first dose of study treatment.
* Has a known history of an additional malignancy, except if the participant has undergone potentially curative therapy with no evidence of disease recurrence for 3 years since initiation of that therapy.
* Has known active central nervous system metastases and/or carcinomatous meningitis.
* Has severe hypersensitivity to pembrolizumab and/or any of its excipients.
* Has a sensitivity to any of the excipients contained in lenvatinib and/or docetaxel.
* Has an active autoimmune disease that has required systemic treatment in the past 2 years.
* Has a history of (noninfectious) pneumonitis that required systemic steroids or current pneumonitis/interstitial lung disease.
* Has an active infection requiring systemic therapy.
* Has a known history of human immunodeficiency virus (HIV) infection.
* Has a known history of hepatitis B reactive or known active hepatitis C virus infection.
* Has active tuberculosis.
* Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.
* Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through at least 120 days after the last dose of pembrolizumab or lenvatinib, or 90 days (male participants) or 30 days (for female participants) after the last dose of docetaxel.
* Has had an allogeneic tissue/solid organ transplant.

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to ~47 months
measure: Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
timeFrame: Up to ~47 months
Secondary outcomes:
measure: Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - Pembrolizumab+Lenvatinib vs. Docetaxel
timeFrame: Up to ~47 months
measure: Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - Pembrolizumab+Lenvatinib vs. Lenvatinib Monotherapy
timeFrame: Up to ~47 months
measure: Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
timeFrame: Up to ~47 months
measure: Number of Participants Experiencing an Adverse Event (AE)
timeFrame: Up to ~47 months
measure: Number of Participants Discontinuing Study Treatment Due to an AE
timeFrame: Up to ~47 months
measure: Change From Baseline in European Organization for Research and Treatment (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Combined Global Health Status / Quality of Life (Items 29 & 30) Scale Combined Score
timeFrame: Baseline and Week 12
measure: Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Cough (Item 31) Scale Score
timeFrame: Baseline and Week 12
measure: Change From Baseline in EORTC QLQ-LC13 Chest Pain (Item 40) Scale Score
timeFrame: Baseline and Week 12
measure: Change From Baseline in EORTC QLQ-C30 Dyspnea (Item 8) Scale Score
timeFrame: Baseline and Week 12
measure: Change From Baseline in EORTC QLQ-C30 Physical Functioning (Items 1 to 5) Scale Combined Score
timeFrame: Baseline and Week 12
measure: Time to True Deterioration (TTD) in EORTC QLQ-C30 Combined Global Health Status / Quality of Life (Items 29 & 30) Scale Combined Score
timeFrame: Up to 24 months
measure: Time to True Deterioration (TTD) in EORTC QLQ-LC13 Cough (Item 31) Scale Score
timeFrame: Up to ~24 months
measure: Time to True Deterioration (TTD) in EORTC QLQ-LC13 Chest Pain (Item 40) Scale Score
timeFrame: Up to ~24 months
measure: Time to True Deterioration (TTD) in EORTC QLQ-C30 Dyspnea (Item 8) Scale Score
timeFrame: Up to ~24 months
measure: Time to True Deterioration (TTD) in EORTC QLQ-C30 Physical Functioning (Items 1 to 5) Scale Combined Score
timeFrame: Up to ~24 months
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: Comprehensive Blood & Cancer Center [Bakersfield, CA] ( Site 1604)
state: California
city: Fleming Island
country: United States
facility: Cancer Specialists of North Florida - Fleming Island ( Site 1675)
state: Florida
city: Orange City
country: United States
facility: Mid-Florida Cancer Centers ( Site 1611)
state: Florida
city: Lexington
country: United States
facility: University of Kentucky School of Medicine & Hospitals ( Site 1621)
state: Kentucky
city: Baton Rouge
country: United States
facility: Hematology Oncology Clinic ( Site 1680)
state: Louisiana
city: Baltimore
country: United States
facility: Harry & Jeanette Weinberg Cancer Institute ( Site 1626)
state: Maryland
city: Baltimore
country: United States
facility: Medstar Good Samaritan Hospital ( Site 1625)
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital ( Site 1622)
state: Massachusetts
city: Danvers
country: United States
facility: MGH - North Shore Cancer Center ( Site 1668)
state: Massachusetts
city: Newton
country: United States
facility: The Mass General Cancer Center at Newton-Wellesley ( Site 1692)
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts Medical School ( Site 1693)
state: Massachusetts
city: Billings
country: United States
facility: Billings Clinic ( Site 1631)
state: Montana
city: Bozeman
country: United States
facility: Bozeman Health Deaconness Cancer Center ( Site 1632)
state: Montana
city: Basking Ridge
country: United States
facility: Memorial Sloan-Kettering Cancer Center At Basking Ridge ( Site 1664)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan-Kettering Cancer Center at Middletown ( Site 1665)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan-Kettering Cancer Center at Montvale ( Site 1667)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan-Kettering Cancer Center at Commack ( Site 1662)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan-Kettering Cancer Center at West Harrison ( Site 1666)
state: New York
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center ( Site 1661)
state: New York
city: Port Jefferson Station
country: United States
facility: New York Cancer and Blood Specialists ( Site 1696)
state: New York
city: Rochester
country: United States
facility: University of Rochester ( Site 1638)
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Cancer Center - Nassau ( Site 1670)
state: New York
city: Cincinnati
country: United States
facility: TriHealth Cancer Institute ( Site 1672)
state: Ohio
city: Cleveland
country: United States
facility: MetroHealth Medical Center ( Site 1694)
state: Ohio
city: Portland
country: United States
facility: Kaiser Permanente Center for Health Research-Kaiser Permanente Medical Center ( Site 1644)
state: Oregon
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center ( Site 1647)
state: Pennsylvania
city: Knoxville
country: United States
facility: Thompson Cancer Survival Center ( Site 1695)
state: Tennessee
city: Houston
country: United States
facility: Millenium Physicians ( Site 1690)
state: Texas
city: Caba
country: Argentina
facility: Instituto de Investigaciones Metabolicas ( Site 2004)
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Hospital Britanico de Buenos Aires ( Site 2002)
state: Caba
city: Rosario
country: Argentina
facility: Sanatorio Parque ( Site 2005)
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Hospital Aleman ( Site 2000)
city: Buenos Aires
country: Argentina
facility: CEMIC ( Site 2003)
city: Blacktown
country: Australia
facility: Blacktown Hospital ( Site 0004)
state: New South Wales
city: Port Macquarie
country: Australia
facility: Port Macquarie Base Hospital ( Site 0003)
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital ( Site 0005)
state: New South Wales
city: Wollongong
country: Australia
facility: Southern Medical Day Care Centre ( Site 0001)
state: New South Wales
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital - Division of Cancer Services ( Site 0002)
state: Queensland
city: Elizabeth Vale
country: Australia
facility: Calvary Central Districts Hospital ( Site 0007)
state: South Australia
city: Bendigo
country: Australia
facility: Bendigo Cancer Centre ( Site 0008)
state: Victoria
city: Winnipeg
country: Canada
facility: CancerCare Manitoba ( Site 1504)
state: Manitoba
city: Kingston
country: Canada
facility: Kingston Health Sciences Centre ( Site 1503)
state: Ontario
city: London
country: Canada
facility: London Regional Cancer Program - London HSC ( Site 1505)
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre ( Site 1502)
state: Ontario
city: Montreal
country: Canada
facility: CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 1501)
state: Quebec
city: Quebec
country: Canada
facility: CHUQ-Univ Laval-Hotel Dieu de Quebec ( Site 1514)
city: Medellin
country: Colombia
facility: Rodrigo Botero SAS ( Site 1300)
state: Antioquia
city: Barranquilla
country: Colombia
facility: Clinica de la Costa Ltda. ( Site 1309)
state: Atlantico
city: Valledupar
country: Colombia
facility: Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 1305)
state: Cesar
city: Monteria
country: Colombia
facility: Oncomedica S.A. ( Site 1302)
state: Cordoba
city: Bogota
country: Colombia
facility: Administradora Country SA - Clinica del Country ( Site 1307)
state: Distrito Capital De Bogota
city: Bogota
country: Colombia
facility: Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 1304)
state: Distrito Capital De Bogota
city: Cali
country: Colombia
facility: Centro Medico Imbanaco de Cali S.A ( Site 1301)
state: Valle Del Cauca
city: Caen
country: France
facility: CHU Caen Service de Pneumologie ( Site 0401)
state: Calvados
city: Clamart
country: France
facility: HIA Percy-Clamart ( Site 0411)
state: Hauts-de-Seine
city: Angers
country: France
facility: ICO Centre Paul Papin ( Site 0412)
state: Maine-et-Loire
city: Beuvry
country: France
facility: Clinique Ambroise Pare ( Site 0402)
state: Pas-de-Calais
city: Avignon
country: France
facility: Centre Hospitalier General - Avignon ( Site 0407)
state: Provence-Alpes-Cote-d Azur
city: Le Mans
country: France
facility: Centre Hospitalier Le Mans ( Site 0406)
state: Sarthe
city: Paris
country: France
facility: Institut Curie ( Site 0400)
city: Paris
country: France
facility: Hopital Europeen Georges Pompidou ( Site 0408)
city: Heidelberg
country: Germany
facility: Thoraxklinik Heidelberg gGmbH am Universitaetsklinikum Heidelberg ( Site 0501)
state: Baden-Wurttemberg
city: Hamm
country: Germany
facility: Evangelisches Krankenhaus Hamm gGmbH ( Site 0504)
state: Nordrhein-Westfalen
city: Gera
country: Germany
facility: SRH Wald-Klinikum Gera GmbH ( Site 0503)
state: Thuringen
city: Berlin
country: Germany
facility: Vivantes Klinikum Spandau ( Site 0505)
city: Athens
country: Greece
facility: General Hospital of Chest Diseases "Sotiria" ( Site 1703)
state: Attiki
city: Athens
country: Greece
facility: Metropolitan Hospital-4th Oncology Dept ( Site 1700)
state: Attiki
city: Ioannina
country: Greece
facility: University Hospital of Ioannina ( Site 1701)
city: Thessaloniki
country: Greece
facility: European Interbalkan Medical Center ( Site 1704)
city: Miskolc
country: Hungary
facility: Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház ( Site 0601)
state: Borsod-Abauj-Zemplen
city: Szekesfehervar
country: Hungary
facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz ( Site 0606)
state: Fejer
city: Gyor
country: Hungary
facility: Petz Aladar Megyei Oktato Korhaz ( Site 0609)
state: Gyor-Moson-Sopron
city: Szolnok
country: Hungary
facility: Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 0610)
state: Jasz-Nagykun-Szolnok
city: Torokbalint
country: Hungary
facility: Tudogyogyintezet Torokbalint ( Site 0602)
state: Pest
city: Farkasgyepu
country: Hungary
facility: Veszprem Megyei Tudogyogyintezet ( Site 0607)
state: Veszprem
city: Budapest
country: Hungary
facility: Semmelweis Egyetem.. ( Site 0604)
city: Budapest
country: Hungary
facility: Orszagos Koranyi Pulmonologiai Intezet ( Site 0603)
city: Budapest
country: Hungary
facility: Orszagos Koranyi Pulmonologiai Intezet ( Site 0608)
city: Beer Sheva
country: Israel
facility: Soroka Medical Center ( Site 0701)
city: Haifa
country: Israel
facility: Rambam Medical Center ( Site 0703)
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center-Oncology ( Site 0706)
city: Kfar-Saba
country: Israel
facility: Meir Medical Center ( Site 0702)
city: Petah Tikva
country: Israel
facility: Rabin Medical Center ( Site 0700)
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center ( Site 0704)
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center (Ichilov) - Oncology Clinic ( Site 0705)
city: Monza
country: Italy
facility: Ospedale San Gerardo - ASST Monza ( Site 0804)
state: Monza E Brianza
city: Rome
country: Italy
facility: Istittuto Nazionale dei Tumori Regina Elena IRCCS - IFO ( Site 0807)
state: Roma
city: Palermo
country: Italy
facility: A.O. Ospedali Riuniti Villa Sofia - Cervello P.O. Villa Sofia ( Site 0810)
state: Sicilia
city: Orbassano
country: Italy
facility: Ospedale San Luigi Gonzaga ( Site 0802)
state: Torino
city: Avellino
country: Italy
facility: Azienda Ospedaliera San Giuseppe Moscati ( Site 0809)
city: Bari
country: Italy
facility: IRCCS Giovanni Paolo II. Ospedale Oncologico ( Site 0808)
city: Catania
country: Italy
facility: AOU Policlinico Vittorio Emanuele ( Site 0811)
city: Milano
country: Italy
facility: Istituto Nazionale dei Tumori ( Site 0806)
city: Pavia
country: Italy
facility: Policlinico San Matteo - Fondazione IRCCS ( Site 0812)
city: Perugia
country: Italy
facility: Azienda Ospedaliera di Perugia ( Site 0805)
city: Yokohama
country: Japan
facility: Kanagawa Cardiovascular and Respiratory Center ( Site 0105)
state: Kanagawa
city: Sendai
country: Japan
facility: Sendai Kousei Hospital ( Site 0107)
state: Miyagi
city: Hirakata
country: Japan
facility: Kansai Medical University Hospital ( Site 0104)
state: Osaka
city: Chiba
country: Japan
facility: Chiba University Hospital ( Site 0106)
city: Niigata
country: Japan
facility: Niigata Cancer Center Hospital ( Site 0101)
city: Tokyo
country: Japan
facility: National Cancer Center Hospital ( Site 0103)
city: Tokyo
country: Japan
facility: The Cancer Institute Hospital of JFCR ( Site 0100)
city: Cheongju si
country: Korea, Republic of
facility: Chungbuk National University Hospital ( Site 0201)
state: Chungbuk
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital ( Site 0204)
state: Kyonggi-do
city: Songpagu
country: Korea, Republic of
facility: Asan Medical Center ( Site 0203)
state: Seoul
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System ( Site 0202)
city: Lisboa
country: Portugal
facility: Centro Hospitalar Lisboa Norte E.P.E. - Hospital Pulido Valente ( Site 1801)
city: Porto
country: Portugal
facility: Hospital CUF Porto ( Site 1802)
city: Porto
country: Portugal
facility: Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 1800)
city: Manati
country: Puerto Rico
facility: Hematology and Oncology Institute ( Site 2105)
city: Ponce
country: Puerto Rico
facility: Ad-Vance Medical Research LLC ( Site 2103)
city: San Juan
country: Puerto Rico
facility: Puerto Rico Medical Research Center LLC ( Site 2101)
city: Ufa
country: Russian Federation
facility: GBUZ Republican Clinical Oncological Dispensary ( Site 0922)
state: Baskortostan, Respublika
city: Krasnoyarsk
country: Russian Federation
facility: Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0918)
state: Krasnoyarskiy Kray
city: Moscow
country: Russian Federation
facility: Main Military Clinical Hospital n.a. N.N.Burdenko ( Site 0905)
state: Moskva
city: Moscow
country: Russian Federation
facility: Central Clinical Hospital of the Administration of the President ( Site 0910)
state: Moskva
city: Omsk
country: Russian Federation
facility: Budgetary Healthcare Institution of Omsk Region Clinical Oncology Dispensary-Chemotherapy #1 ( Site
state: Omskaya Oblast
city: Saint Petersburg
country: Russian Federation
facility: SPb SBHI City Clinical Oncological Dispensary ( Site 0901)
state: Sankt-Peterburg
city: Saint-Petersburg
country: Russian Federation
facility: Railway Hospital of OJSC ( Site 0907)
state: Sankt-Peterburg
city: Saint-Petersburg
country: Russian Federation
facility: Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 0903)
state: Sankt-Peterburg
city: Sankt- Peterburg
country: Russian Federation
facility: GBUZ SPb CRPCstmc(o) ( Site 0921)
state: Sankt-Peterburg
city: St. Petersburg
country: Russian Federation
facility: Pavlov First Saint Petersburg State Medical University ( Site 0917)
state: Sankt-Peterburg
city: Oviedo
country: Spain
facility: Hospital Central de Asturias ( Site 1002)
state: Asturias
city: Mataro
country: Spain
facility: Consorci Hospitalari Mataro ( Site 1008)
state: Barcelona
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla ( Site 1003)
state: Cantabria
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Universitario Insular de Gran Canaria ( Site 1011)
state: Las Palmas
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro ( Site 1007)
state: Madrid
city: Pozuelo de Alarcon
country: Spain
facility: Hospital Universitario Quiron Madrid ( Site 1012)
state: Madrid
city: Valencia
country: Spain
facility: Hospital Clinico de Valencia ( Site 1010)
state: Valenciana, Comunitat
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d Hebron ( Site 1004)
city: Jaen
country: Spain
facility: Hospital Ciudad de Jaen ( Site 1000)
city: Madrid
country: Spain
facility: Hospital Universitario Fundacion Jimenez Diaz ( Site 1005)
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre ( Site 1006)
city: Cottingham
country: United Kingdom
facility: Hull & East Yorkshire NHS Trust. Castle Hill Hospital ( Site 1108)
state: East Riding Of Yorkshire
city: Nottingham
country: United Kingdom
facility: Nottingham City Hospital Campus ( Site 1105)
state: England
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary ( Site 1110)
state: Leicestershire
city: London
country: United Kingdom
facility: North Middlesex University Hospital NHS Trust ( Site 1109)
state: London, City Of
city: London
country: United Kingdom
facility: Guy s and St Thomas Hospital NHS Foundation Trust ( Site 1102)
state: London, City Of
city: Northwood
country: United Kingdom
facility: Mount Vernon Cancer Centre ( Site 1107)
state: London, City Of
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary ( Site 1114)
state: Scotland
city: Coventry
country: United Kingdom
facility: University Hospital Coventry and Warwickshire NHS Trust ( Site 1112)
state: Warwickshire
city: Birmingham
country: United Kingdom
facility: Birmingham Heartlands Hospital ( Site 1103)
city: Leeds
country: United Kingdom
facility: St James s University Hospital ( Site 1106)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Xing P, Wang M, Zhao J, Zhong W, Chi Y, Xu Z, Li J. Study protocol: A single-arm, multicenter, phase II trial of camrelizumab plus apatinib for advanced nonsquamous NSCLC previously treated with first-line immunotherapy. Thorac Cancer. 2021 Oct;12(20):2825-2828. doi: 10.1111/1759-7714.14113. Epub 2021 Aug 18.
citation: Taylor MH, Schmidt EV, Dutcus C, Pinheiro EM, Funahashi Y, Lubiniecki G, Rasco D. The LEAP program: lenvatinib plus pembrolizumab for the treatment of advanced solid tumors. Future Oncol. 2021 Feb;17(6):637-648. doi: 10.2217/fon-2020-0937. Epub 2020 Dec 10.