Phase
Condition
N/ATreatment
Lenvatinib
Docetaxel
Pembrolizumab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Has a histologically or cytologically confirmed diagnosis of metastatic squamous ornonsquamous 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 checkpointinhibitors or other therapies.
Retreatment with the same anti-PD-L1/PD-L1 mAb is acceptable in the overallcourse of treatment
Has PD during/after platinum doublet chemotherapy for metastatic disease.
Has confirmation that EGFR-, ALK-, or ROS1-directed therapy is not indicated asprimary therapy (documentation of absence of tumor-activating EGFR mutations [eg,DEL19 or L858R], and absence of ALK and ROS1 gene rearrangements OR presence of aK-ras mutation).
Has submitted pre-study imaging that confirmed evidence of PD following initiationof an anti-PD-1/PD-L1 inhibitor.
Has at least 1 measurable lesion by computerized tomography (CT) or magneticresonance 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 samplefrom 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 previouslyirradiated.
Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7days 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 torefrain from donating sperm, and either 1) be abstinent from heterosexualintercourse; or 2) follow contraceptive guidance during the treatment period or 7days after the last dose of lenvatinib. Male participants receiving docetaxel agreeto adhere to the same conditions during the treatment period and for ≥90 days afterthe last dose of study treatment.
Female participants must not be pregnant, not be breastfeeding, and not be a womanof child-bearing potential (WOCBP). If a WOCBP, agrees to not donate eggs and eitheruse contraception, or be abstinent from heterosexual intercourse during thetreatment period and for ≥120 days after the last dose of pembrolizumab or 30 daysafter the last dose of lenvatinib, whichever occurs last. If a WOCBP receivingdocetaxel, agrees to adhere to the same conditions during the treatment period andfor ≥30 days after the last dose of study treatment.
Has adequately controlled blood pressure (BP) with or without antihypertensivemedications, defined as BP ≤150/90 mm Hg and no change in antihypertensivemedications within 1 week before randomization.
If participant received major surgery or radiation therapy of >30 Gy, they haverecovered from the toxicity and/or complications from the intervention.
Has adequate organ function.
Exclusion
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-L1mAb.
Has received: 1) radiotherapy within 2 weeks before the first dose of studytreatment; or 2) lung radiation therapy >30 Gy within 6 months before the first doseof 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 thefirst dose of study treatment.
Has radiographic evidence of intratumoral cavitation, encasement, or invasion of amajor blood vessel.
Has clinically significant cardiovascular impairment within 12 months of the firstdose of study treatment.
Has a history of a gastrointestinal condition or procedure that may affect oralabsorption 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 orparticipated in a study of an investigational agent within 4 weeks of the first doseof study treatment.
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapyor any other form of immunosuppressive therapy within 7 days before the first doseof study treatment.
Has a known history of an additional malignancy, except if the participant hasundergone potentially curative therapy with no evidence of disease recurrence for 3years 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 2years.
Has a history of (noninfectious) pneumonitis that required systemic steroids orcurrent 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 virusinfection.
Has active tuberculosis.
Has a known psychiatric or substance abuse disorder that would interfere with theparticipant's ability to cooperate with the requirements of the study.
Is pregnant or breastfeeding or expecting to conceive or father children within theprojected 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 (maleparticipants) or 30 days (for female participants) after the last dose of docetaxel.
Has had an allogeneic tissue/solid organ transplant.
Study Design
Connect with a study center
Instituto de Investigaciones Metabolicas ( Site 2004)
Caba, Buenos Aires C1012AAR
ArgentinaSite Not Available
Hospital Britanico de Buenos Aires ( Site 2002)
Buenos Aires, Caba C1280AEB
ArgentinaSite Not Available
Sanatorio Parque ( Site 2005)
Rosario, Santa Fe S2000DSV
ArgentinaSite Not Available
CEMIC ( Site 2003)
Buenos Aires, C1431FWO
ArgentinaSite Not Available
Hospital Aleman ( Site 2000)
Buenos Aires, C1118AAT
ArgentinaSite Not Available
Blacktown Hospital ( Site 0004)
Blacktown, New South Wales 2148
AustraliaSite Not Available
Port Macquarie Base Hospital ( Site 0003)
Port Macquarie, New South Wales 2444
AustraliaSite Not Available
Westmead Hospital ( Site 0005)
Westmead, New South Wales 2145
AustraliaSite Not Available
Southern Medical Day Care Centre ( Site 0001)
Wollongong, New South Wales 2500
AustraliaSite Not Available
Princess Alexandra Hospital - Division of Cancer Services ( Site 0002)
Woolloongabba, Queensland 4102
AustraliaSite Not Available
Calvary Central Districts Hospital ( Site 0007)
Elizabeth Vale, South Australia 5112
AustraliaSite Not Available
Bendigo Cancer Centre ( Site 0008)
Bendigo, Victoria 3552
AustraliaSite Not Available
CancerCare Manitoba ( Site 1504)
Winnipeg, Manitoba R3E 0V9
CanadaSite Not Available
Kingston Health Sciences Centre ( Site 1503)
Kingston, Ontario K7L 2V7
CanadaSite Not Available
London Regional Cancer Program - London HSC ( Site 1505)
London, Ontario N6A 5W9
CanadaSite Not Available
Princess Margaret Cancer Centre ( Site 1502)
Toronto, Ontario M5G 2M9
CanadaSite Not Available
CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 1501)
Montreal, Quebec H3T 1M5
CanadaSite Not Available
CHUQ-Univ Laval-Hotel Dieu de Quebec ( Site 1514)
Quebec, G1R 2J6
CanadaSite Not Available
Rodrigo Botero SAS ( Site 1300)
Medellin, Antioquia 050030
ColombiaSite Not Available
Clinica de la Costa Ltda. ( Site 1309)
Barranquilla, Atlantico 080020
ColombiaSite Not Available
Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 1305)
Valledupar, Cesar 200001
ColombiaSite Not Available
Oncomedica S.A. ( Site 1302)
Monteria, Cordoba 230001
ColombiaSite Not Available
Administradora Country SA - Clinica del Country ( Site 1307)
Bogota, Distrito Capital De Bogota 110221
ColombiaSite Not Available
Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 1304)
Bogota, Distrito Capital De Bogota 110311
ColombiaSite Not Available
Centro Medico Imbanaco de Cali S.A ( Site 1301)
Cali, Valle Del Cauca 760042
ColombiaSite Not Available
CHU Caen Service de Pneumologie ( Site 0401)
Caen, Calvados 14033
FranceSite Not Available
HIA Percy-Clamart ( Site 0411)
Clamart, Hauts-de-Seine 92140
FranceSite Not Available
ICO Centre Paul Papin ( Site 0412)
Angers, Maine-et-Loire 49100
FranceSite Not Available
Clinique Ambroise Pare ( Site 0402)
Beuvry, Pas-de-Calais 62660
FranceSite Not Available
Centre Hospitalier General - Avignon ( Site 0407)
Avignon, Provence-Alpes-Cote-d Azur 84000
FranceSite Not Available
Centre Hospitalier Le Mans ( Site 0406)
Le Mans, Sarthe 72037
FranceSite Not Available
Hopital Europeen Georges Pompidou ( Site 0408)
Paris, 75015
FranceSite Not Available
Institut Curie ( Site 0400)
Paris, 75005
FranceSite Not Available
Thoraxklinik Heidelberg gGmbH am Universitaetsklinikum Heidelberg ( Site 0501)
Heidelberg, Baden-Wurttemberg 69126
GermanySite Not Available
Evangelisches Krankenhaus Hamm gGmbH ( Site 0504)
Hamm, Nordrhein-Westfalen 59063
GermanySite Not Available
SRH Wald-Klinikum Gera GmbH ( Site 0503)
Gera, Thuringen 07548
GermanySite Not Available
Vivantes Klinikum Spandau ( Site 0505)
Berlin, 13585
GermanySite Not Available
General Hospital of Chest Diseases "Sotiria" ( Site 1703)
Athens, Attiki 115 27
GreeceSite Not Available
Metropolitan Hospital-4th Oncology Dept ( Site 1700)
Athens, Attiki 185 47
GreeceSite Not Available
University Hospital of Ioannina ( Site 1701)
Ioannina, 455 00
GreeceSite Not Available
European Interbalkan Medical Center ( Site 1704)
Thessaloniki, 570 01
GreeceSite Not Available
Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház ( Site 0601)
Miskolc, Borsod-Abauj-Zemplen 3526
HungarySite Not Available
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz ( Site 0606)
Szekesfehervar, Fejer 8000
HungarySite Not Available
Petz Aladar Megyei Oktato Korhaz ( Site 0609)
Gyor, Gyor-Moson-Sopron 9024
HungarySite Not Available
Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 0610)
Szolnok, Jasz-Nagykun-Szolnok 5004
HungarySite Not Available
Tudogyogyintezet Torokbalint ( Site 0602)
Torokbalint, Pest 2045
HungarySite Not Available
Veszprem Megyei Tudogyogyintezet ( Site 0607)
Farkasgyepu, Veszprem 8582
HungarySite Not Available
Orszagos Koranyi Pulmonologiai Intezet ( Site 0603)
Budapest, 1121
HungarySite Not Available
Orszagos Koranyi Pulmonologiai Intezet ( Site 0608)
Budapest, 1121
HungarySite Not Available
Semmelweis Egyetem.. ( Site 0604)
Budapest, 1083
HungarySite Not Available
Soroka Medical Center ( Site 0701)
Beer Sheva, 8410101
IsraelSite Not Available
Rambam Medical Center ( Site 0703)
Haifa, 3525408
IsraelSite Not Available
Shaare Zedek Medical Center-Oncology ( Site 0706)
Jerusalem, 9013102
IsraelSite Not Available
Meir Medical Center ( Site 0702)
Kfar-Saba, 4428132
IsraelSite Not Available
Rabin Medical Center ( Site 0700)
Petah Tikva, 4941492
IsraelSite Not Available
Chaim Sheba Medical Center ( Site 0704)
Ramat Gan, 5262000
IsraelSite Not Available
Sourasky Medical Center (Ichilov) - Oncology Clinic ( Site 0705)
Tel Aviv, 6423906
IsraelSite Not Available
Ospedale San Gerardo - ASST Monza ( Site 0804)
Monza, Monza E Brianza 20900
ItalySite Not Available
Istittuto Nazionale dei Tumori Regina Elena IRCCS - IFO ( Site 0807)
Rome, Roma 00144
ItalySite Not Available
A.O. Ospedali Riuniti Villa Sofia - Cervello P.O. Villa Sofia ( Site 0810)
Palermo, Sicilia 90146
ItalySite Not Available
Ospedale San Luigi Gonzaga ( Site 0802)
Orbassano, Torino 10043
ItalySite Not Available
Azienda Ospedaliera San Giuseppe Moscati ( Site 0809)
Avellino, 83100
ItalySite Not Available
IRCCS Giovanni Paolo II. Ospedale Oncologico ( Site 0808)
Bari, 70124
ItalySite Not Available
AOU Policlinico Vittorio Emanuele ( Site 0811)
Catania, 95123
ItalySite Not Available
Istituto Nazionale dei Tumori ( Site 0806)
Milano, 20133
ItalySite Not Available
Policlinico San Matteo - Fondazione IRCCS ( Site 0812)
Pavia, 27100
ItalySite Not Available
Azienda Ospedaliera di Perugia ( Site 0805)
Perugia, 06132
ItalySite Not Available
Kanagawa Cardiovascular and Respiratory Center ( Site 0105)
Yokohama, Kanagawa 236-0051
JapanSite Not Available
Sendai Kousei Hospital ( Site 0107)
Sendai, Miyagi 980-0873
JapanSite Not Available
Kansai Medical University Hospital ( Site 0104)
Hirakata, Osaka 573-1191
JapanSite Not Available
Chiba University Hospital ( Site 0106)
Chiba, 260-8677
JapanSite Not Available
Niigata Cancer Center Hospital ( Site 0101)
Niigata, 951-8566
JapanSite Not Available
National Cancer Center Hospital ( Site 0103)
Tokyo, 104-0045
JapanSite Not Available
The Cancer Institute Hospital of JFCR ( Site 0100)
Tokyo, 135-8550
JapanSite Not Available
Chungbuk National University Hospital ( Site 0201)
Cheongju si, Chungbuk 28644
Korea, Republic ofSite Not Available
Seoul National University Bundang Hospital ( Site 0204)
Seongnam-si, Kyonggi-do 13620
Korea, Republic ofSite Not Available
Asan Medical Center ( Site 0203)
Songpagu, Seoul 05505
Korea, Republic ofSite Not Available
Severance Hospital Yonsei University Health System ( Site 0202)
Seoul, 03722
Korea, Republic ofSite Not Available
Centro Hospitalar Lisboa Norte E.P.E. - Hospital Pulido Valente ( Site 1801)
Lisboa, 1769-001
PortugalSite Not Available
Hospital CUF Porto ( Site 1802)
Porto, 4100-180
PortugalSite Not Available
Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 1800)
Porto, 4200-072
PortugalSite Not Available
Hematology and Oncology Institute ( Site 2105)
Manati, 00674
Puerto RicoSite Not Available
Ad-Vance Medical Research LLC ( Site 2103)
Ponce, 00717
Puerto RicoSite Not Available
Puerto Rico Medical Research Center LLC ( Site 2101)
San Juan, 00918
Puerto RicoSite Not Available
GBUZ Republican Clinical Oncological Dispensary ( Site 0922)
Ufa, Baskortostan, Respublika 450054
Russian FederationSite Not Available
Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0918)
Krasnoyarsk, Krasnoyarskiy Kray 660133
Russian FederationSite Not Available
Central Clinical Hospital of the Administration of the President ( Site 0910)
Moscow, Moskva 121359
Russian FederationSite Not Available
Main Military Clinical Hospital n.a. N.N.Burdenko ( Site 0905)
Moscow, Moskva 105094
Russian FederationSite Not Available
Budgetary Healthcare Institution of Omsk Region Clinical Oncology Dispensary-Chemotherapy #1 ( Site
Omsk, Omskaya Oblast 644013
Russian FederationSite Not Available
SPb SBHI City Clinical Oncological Dispensary ( Site 0901)
Saint Petersburg, Sankt-Peterburg 198255
Russian FederationSite Not Available
Railway Hospital of OJSC ( Site 0907)
Saint-Petersburg, Sankt-Peterburg 195271
Russian FederationSite Not Available
Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 0903)
Saint-Petersburg, Sankt-Peterburg 197758
Russian FederationSite Not Available
GBUZ SPb CRPCstmc(o) ( Site 0921)
Sankt- Peterburg, Sankt-Peterburg 197758
Russian FederationSite Not Available
Pavlov First Saint Petersburg State Medical University ( Site 0917)
St. Petersburg, Sankt-Peterburg 197022
Russian FederationSite Not Available
Hospital Central de Asturias ( Site 1002)
Oviedo, Asturias 33011
SpainSite Not Available
Consorci Hospitalari Mataro ( Site 1008)
Mataro, Barcelona 08304
SpainSite Not Available
Hospital Universitario Marques de Valdecilla ( Site 1003)
Santander, Cantabria 39008
SpainSite Not Available
Hospital Universitario Insular de Gran Canaria ( Site 1011)
Las Palmas de Gran Canaria, Las Palmas 35001
SpainSite Not Available
Hospital Universitario Puerta de Hierro ( Site 1007)
Majadahonda, Madrid 28222
SpainSite Not Available
Hospital Universitario Quiron Madrid ( Site 1012)
Pozuelo de Alarcon, Madrid 28223
SpainSite Not Available
Hospital Clinico de Valencia ( Site 1010)
Valencia, Valenciana, Comunitat 46010
SpainSite Not Available
Hospital Universitari Vall d Hebron ( Site 1004)
Barcelona, 08035
SpainSite Not Available
Hospital Ciudad de Jaen ( Site 1000)
Jaen, 23007
SpainSite Not Available
Hospital Universitario 12 de Octubre ( Site 1006)
Madrid, 28041
SpainSite Not Available
Hospital Universitario Fundacion Jimenez Diaz ( Site 1005)
Madrid, 28040
SpainSite Not Available
Hull & East Yorkshire NHS Trust. Castle Hill Hospital ( Site 1108)
Cottingham, East Riding Of Yorkshire HU16 5JQ
United KingdomSite Not Available
Nottingham City Hospital Campus ( Site 1105)
Nottingham, England NG5 1PB
United KingdomSite Not Available
Leicester Royal Infirmary ( Site 1110)
Leicester, Leicestershire LE1 5WW
United KingdomSite Not Available
Guy s and St Thomas Hospital NHS Foundation Trust ( Site 1102)
London, London, City Of SE1 9RT
United KingdomSite Not Available
North Middlesex University Hospital NHS Trust ( Site 1109)
London, London, City Of N18 1QX
United KingdomSite Not Available
Mount Vernon Cancer Centre ( Site 1107)
Northwood, London, City Of HA6 2RN
United KingdomSite Not Available
Aberdeen Royal Infirmary ( Site 1114)
Aberdeen, Scotland AB25 2ZN
United KingdomSite Not Available
University Hospital Coventry and Warwickshire NHS Trust ( Site 1112)
Coventry, Warwickshire CV2 2DX
United KingdomSite Not Available
Birmingham Heartlands Hospital ( Site 1103)
Birmingham, B9 5SS
United KingdomSite Not Available
St James s University Hospital ( Site 1106)
Leeds, LS9 7TF
United KingdomSite Not Available
Comprehensive Blood & Cancer Center [Bakersfield, CA] ( Site 1604)
Bakersfield, California 93309
United StatesSite Not Available
Cancer Specialists of North Florida - Fleming Island ( Site 1675)
Fleming Island, Florida 32003
United StatesSite Not Available
Mid-Florida Cancer Centers ( Site 1611)
Orange City, Florida 32763
United StatesSite Not Available
University of Kentucky School of Medicine & Hospitals ( Site 1621)
Lexington, Kentucky 40536
United StatesSite Not Available
Hematology Oncology Clinic ( Site 1680)
Baton Rouge, Louisiana 70809
United StatesSite Not Available
Harry & Jeanette Weinberg Cancer Institute ( Site 1626)
Baltimore, Maryland 21237
United StatesSite Not Available
Medstar Good Samaritan Hospital ( Site 1625)
Baltimore, Maryland 21239
United StatesSite Not Available
Massachusetts General Hospital ( Site 1622)
Boston, Massachusetts 02114
United StatesSite Not Available
MGH - North Shore Cancer Center ( Site 1668)
Danvers, Massachusetts 01923
United StatesSite Not Available
The Mass General Cancer Center at Newton-Wellesley ( Site 1692)
Newton, Massachusetts 02462
United StatesSite Not Available
University of Massachusetts Medical School ( Site 1693)
Worcester, Massachusetts 01655
United StatesSite Not Available
Billings Clinic ( Site 1631)
Billings, Montana 59101
United StatesSite Not Available
Bozeman Health Deaconness Cancer Center ( Site 1632)
Bozeman, Montana 59715
United StatesSite Not Available
Memorial Sloan-Kettering Cancer Center At Basking Ridge ( Site 1664)
Basking Ridge, New Jersey 07920
United StatesSite Not Available
Memorial Sloan-Kettering Cancer Center at Middletown ( Site 1665)
Middletown, New Jersey 07748
United StatesSite Not Available
Memorial Sloan-Kettering Cancer Center at Montvale ( Site 1667)
Montvale, New Jersey 07645
United StatesSite Not Available
Memorial Sloan-Kettering Cancer Center at Commack ( Site 1662)
Commack, New York 11725
United StatesSite Not Available
Memorial Sloan-Kettering Cancer Center at West Harrison ( Site 1666)
Harrison, New York 10604
United StatesSite Not Available
Memorial Sloan-Kettering Cancer Center ( Site 1661)
New York, New York 10065
United StatesSite Not Available
New York Cancer and Blood Specialists ( Site 1696)
Port Jefferson Station, New York 11776
United StatesSite Not Available
University of Rochester ( Site 1638)
Rochester, New York 14642
United StatesSite Not Available
Memorial Sloan Kettering Cancer Center - Nassau ( Site 1670)
Uniondale, New York 11553
United StatesSite Not Available
TriHealth Cancer Institute ( Site 1672)
Cincinnati, Ohio 45220
United StatesSite Not Available
MetroHealth Medical Center ( Site 1694)
Cleveland, Ohio 44109
United StatesSite Not Available
Kaiser Permanente Center for Health Research-Kaiser Permanente Medical Center ( Site 1644)
Portland, Oregon 97227
United StatesSite Not Available
Fox Chase Cancer Center ( Site 1647)
Philadelphia, Pennsylvania 19111
United StatesSite Not Available
Thompson Cancer Survival Center ( Site 1695)
Knoxville, Tennessee 37916
United StatesSite Not Available
Millenium Physicians ( Site 1690)
Houston, Texas 77090
United StatesSite Not Available
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