Lung Cancer Clinical Trial

Study of DS-1062a Versus Docetaxel in Previously Treated Advanced or Metastatic Non-small Cell Lung Cancer With or Without Actionable Genomic Alterations (TROPION-LUNG01)

Summary

This study will evaluate the efficacy, safety, and pharmacokinetics of DS-1062a versus docetaxel in participants with previously treated advanced or metastatic non-small cell lung cancer (NSCLC) with or without actionable genomic alterations.

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Full Description

This study will evaluate DS-1062a 6.0 mg/kg vs docetaxel 75 mg/m^2 in participants with advanced or metastatic NSCLC with or without actionable genomic alterations (AGAs). Participants without actionable genomic alterations must have been previously treated with platinum-based chemotherapy and α (anti)-programmed cell death 1 (PD-1)/α-programmed cell death ligand 1 (PD-L1) monoclonal antibody, either in combination or sequentially. Participants with AGA must have progressed on or after 1 platinum-containing therapy and 1 to 2 prior lines of approved targeted therapy for the applicable genomic alteration. The study will be divided into 3 periods: Screening Period, Treatment Period, and Follow-up Period.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Participants eligible for inclusion in the study must meet all inclusion criteria within 28 days of randomization into the study.

Sign and date the inform consent form (ICF) prior to the start of any study specific qualification procedures.
Adults ≥18 years (if the legal age of consent is >18 years old, then follow local regulatory requirements)
Life expectancy ≥3 months
Has pathologically documented Stage IIIB, IIIC, or stage IV NSCLC disease with or without actionable genomic alterations (AGA) at the time of randomization (based on the American Joint Committee on Cancer, Eighth Edition) and meets following criteria for NSCLC:

Participants without AGA:

Must have documented negative test results for epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK).
Must have no known genomic alterations in ROS proto-oncogene 1 (ROS1), neurotrophic tyrosine receptor kinase (NTRK), proto oncogene B-raf (BRAF), mesenchymal-epithelial transition (MET) exon 14 skipping, or rearranged during transfection (RET).
Participants with AGA must have one or more documented actionable genomic alteration(s): EGFR, ALK, ROS1, NTRK, BRAF, MET exon 14 skipping, or RET.
Has documentation of radiographic disease progression while on or after receiving the most recent treatment regimen for advanced or metastatic NSCLC.

Participant without AGA must meet 1 of the following prior therapy requirements for advanced or metastatic NSCLC:

Received platinum-based chemotherapy in combination with α-PD-1/α-PD-L1 monoclonal antibody as the only prior line of therapy.

Includes participants who received prior platinum-based/chemotherapy with or without radiotherapy with maintenance α-PD-1/α-PD-L1 monoclonal antibody for Stage III disease and relapsed/progressed within 6 months from the last dose of platinum-based chemotherapy.
Includes participants who received prior platinum-based/chemotherapy with or without radiotherapy (with or without maintenance α-PD-1/α-PD-L1 monoclonal antibody) for Stage III disease and subsequently received α-PD-1/α-PD-L1 monoclonal antibody therapy (with or without platinum-based chemotherapy) for recurrent disease.
Received platinum-based chemotherapy and α-PD-1/α-PD-L1 monoclonal antibody (in either order) sequentially as the only 2 prior lines of therapy.

Participants with AGA must meet the following for advanced or metastatic NSCLC:

Participants who have been treated with 1 or 2 prior lines of applicable targeted therapy that is locally approved for the participant's genomic alteration at the time of screening;

Participants who have tumors with EGFR L858R or exon 19 deletion mutations must have received prior Osimertinib.
Those who received a targeted agent as adjuvant therapy for early-stage disease must have relapsed or progressed while on the treatment or within 6 months of the last dose OR received at least one additional course of targeted therapy for the same genomic alteration (which may or may not be same agent used in the adjuvant setting) for relapsed/progressive disease.
Participants who have been treated with a prior TKI must receive additional approved targeted therapy, if locally available and clinically appropriate, for the applicable genomic alteration, or the participant will not be allowed in the study.

Participants who have received platinum-based chemotherapy as the only prior line of cytotoxic therapy:

One platinum-containing regimen for advanced disease
Those who received a platinum-containing regimen as adjuvant therapy for early-stage disease must have relapsed or progressed while on the treatment or within 6 months of the last dose OR received at least one additional course of platinum-containing therapy (which may or may not be same as in the adjuvant setting) for relapsed/progressive disease.
May have received up to one α-PD-1/α-PD-L1 monoclonal antibody alone or in combination with a cytotoxic agent.
Must undergo a pre-treatment tumor biopsy procedure or if available, tumor tissue previously retrieved from a biopsy procedure performed within 2 years prior to the participant signing informed consent and that has a minimum of 10 × 4 micron sections or a tissue block equivalent of 10 × 4 micron sections may be substituted for the pre-treatment biopsy procedure during Screening. If a documented law or regulation prohibits (or does not approve) sample collection, then such samples will not be collected/submitted
Measurable disease based on local imaging assessment using RECIST v1.1
Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 at Screening
Within 7 days before randomization, has adequate bone marrow, hepatic, and renal function
Left ventricular ejection fraction (LVEF) ≥50% by either echocardiogram (ECHO) or multigated acquisition (MUGA) scan within 28 days before randomization
Adequate blood clotting function defined as international normalized ratio/prothrombin time and either partial thromboplastin or activated partial thromboplastin time ≤1.5 × upper limit of normal (ULN)
Adequate treatment washout period before randomization
Females of childbearing potential must have a negative serum pregnancy test at screening and must be willing to use highly effective birth control from the time of enrollment up to 7 months after the last dose of DS-1062a or for at least 6 months after the last dose of docetaxel
Males must be surgically sterile or must use a condom in addition to highly effective birth control if his partners are of reproductive potential from the time of enrollment and for at least 4 months after last dose of DS-1062a or for at least 6 months after the last dose of docetaxel
Male participants must not freeze or donate sperm from the time of Screening and throughout the study period and for at least 4 months after the last dose of DS-1062a or for at least 6 months after the last dose of docetaxel
Female participants must not donate, or retrieve for their own use, ova from the time of Screening and throughout the study period and for at least 7 months after the last dose of DS-1062a and for at least 6 months after the last dose of docetaxel

Exclusion Criteria:

Mixed small-cell lung cancer (SCLC) and NSCLC histology
Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms. Participants with clinically inactive brain metastases may be included in the study. Participants with treated brain metastases who are no longer symptomatic and who require no treatment with corticosteroids or anticonvulsants may be included in the study if they have recovered from the acute toxic effect of radiotherapy.
Has leptomeningeal carcinomatosis or metastasis

Had prior treatment with:

Any agent including antibody drug conjugate (ADC) containing a chemotherapeutic agent targeting topoisomerase I
TROP2-targeted therapy
Docetaxel
Had prior treatment with platinum-based chemotherapy and prior immunotherapy for Stage II NSCLC disease (eg, in the neo-adjuvant or adjuvant setting) without subsequently meeting the prior therapy requirements for Stage III or metastatic NSCLC disease
Has NSCLC disease that is eligible for definitive local therapy alone

Has uncontrolled or significant cardiac disease, including:

Mean QT interval corrected for heart rate using Fridericia's formula >470 msec (based on the average of Screening triplicate 12-lead electrocardiogram [ECG] determinations).
Myocardial infarction or uncontrolled/unstable angina within 6 months before randomization
Congestive heart failure (CHF) (New York Heart Association Class II to IV) at Screening. Participants with a history of Class II to IV CHF prior to Screening, must have returned to Class I CHF and have LVEF ≥50% (by either an ECHO or MUGA scan within 28 days before randomization) in order to be eligible.
Uncontrolled or significant cardiac arrhythmia
LVEF <50% by ECHO or MUGA scan within 28 days before randomization
Uncontrolled hypertension (resting systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg) within 28 days before randomization
Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening
Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (ie, pulmonary emboli within 3 months before randomization, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc.), or any autoimmune, connective tissue or inflammatory disorders with pulmonary involvement (ie, rheumatoid arthritis, Sjogren's syndrome, sarcoidosis, etc.), or prior pneumonectomy.
Significant third-space fluid retention (for example ascites or pleural effusion) and is not amenable for required repeated drainage
Clinically significant corneal disease
Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals; suspected infections (eg, prodromal symptoms); or inability to rule out infections
Has known human immunodeficiency virus (HIV) infection that is not well controlled
Has an active or uncontrolled hepatitis B and/or hepatitis C infection, is positive for hepatitis B or C virus based on the evaluation of results of tests for hepatitis B (hepatitis B surface antigen [HBsAg], anti-hepatitis B surface antibody [anti-HBs], anti-hepatitis B core antibody [anti-HBc], or hepatitis B virus [HBV] DNA), and/or hepatitis C infection (as per hepatitis C virus [HCV] RNA) within 28 days of randomization.
Has a history of malignancy, other than NSCLC, except adequately resected non-melanoma skin cancer, curatively treated in situ disease, or other solid tumors curatively treated, with no evidence of disease for ≥3 years
Toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet improved to NCI-CTCAE version 5.0 Grade ≤1 or baseline
Has a history of severe hypersensitivity reactions to either the drug substances, inactive ingredients (including but not limited to polysorbate 80) of DS-1062a or docetaxel, or monoclonal antibodies
Pregnant or breastfeeding
Has substance abuse or any other medical conditions such as clinically significant cardiac or psychological conditions

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

590

Study ID:

NCT04656652

Recruitment Status:

Recruiting

Sponsor:

Daiichi Sankyo, Inc.

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There are 211 Locations for this study

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Ironwood Cancer and Research Center
Chandler Arizona, 85224, United States
St. Joseph Heritage Healthcare
Anaheim California, 92835, United States
The Oncology Institute of Hope and Innovation
Glendale California, 91204, United States
University of California San Diego
La Jolla California, 92093, United States
Loma Linda University Cancer Institute
Loma Linda California, 92354, United States
UCLA
Los Angeles California, 90095, United States
PIH Health
Whittier California, 90602, United States
Memorial Healthcare System- Memorial Cancer Institute
Hollywood Florida, 33021, United States
Orlando Health
Orlando Florida, 32806, United States
Florida Cancer Specialists
Tallahassee Florida, 32308, United States
Northwestern University
Chicago Illinois, 60611, United States
University of Chicago
Chicago Illinois, 60637, United States
Ft. Wayne Medical Oncology and Hematology
Fort Wayne Indiana, 46804, United States
University of Kansas
Kansas City Kansas, 66160, United States
Cancer Center of Kansas
Wichita Kansas, 67214, United States
Baptist Health Louisville
Louisville Kentucky, 40207, United States
Baton Rouge General
Baton Rouge Louisiana, 70809, United States
American Oncology Partners of Maryland
Bethesda Maryland, 20817, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02115, United States
Karmanos Cancer Institute
Detroit Michigan, 48201, United States
OptumCare Cancer Care
Las Vegas Nevada, 89106, United States
Comprehensive Cancer Centers of Nevada
Las Vegas Nevada, 89119, United States
Meridian Hematology and Oncology
Manahawkin New Jersey, 08050, United States
Astera Cancer Care
Somerset New Jersey, 08873, United States
Montefiore Medical Center
Bronx New York, 10461, United States
Messino Cancer Centers
Asheville North Carolina, 28806, United States
University Hospitals Cleveland Medical Center
Cleveland Ohio, 44106, United States
Roger Williams Medical Center
Providence Rhode Island, 02908, United States
Avera Cancer Institute
Sioux Falls South Dakota, 57105, United States
Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States
The Center for Cancer and Blood Disorders
Fort Worth Texas, 76104, United States
Utah Cancer Specialists
Salt Lake City Utah, 84106, United States
University of Virginia Health System
Charlottesville Virginia, 22903, United States
Virginia Cancer Specialist
Fairfax Virginia, 22031, United States
Kadlec Clinic Hematology and Oncology
Kennewick Washington, 99336, United States
Northwest Medical Specialties
Tacoma Washington, 98405, United States
CER San Juan
Buenos Aires , 01878, Argentina
Hospital de la Comunidad
Mar Del Plata , B7603, Argentina More Info
Principal Investigator
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Centro de Investigacion Pergamino S.A.
Pergamino , B2700, Argentina
Instituto de OncologÃÂ-a de Rosario
Rosario , S2000, Argentina
Gaston Martinengo
Rosario , S2000, Argentina
Flinders Medical Centre
Bedford Park , 05042, Australia
Blacktown Hosital
Blacktown , 02148, Australia
Austin Hospital
Heidelberg , 03084, Australia
St George Public Hospital
Kogarah , 2217, Australia More Info
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Macquarie Hospital
North Ryde , 02109, Australia
Icon Cancer Centre
South Brisbane , 04101, Australia
Crown Princess Mary Cancer Centre Westmead Hospital
Sydney , 2145, Australia
Southern Medical Day Care Centre
Wollongong , 02500, Australia
Centre Hospitalier Jolimont-Lobbes
Haine-Saint-Paul , 07100, Belgium
CHA Centre Hospitalier de l Ardenne
Libramont , B-680, Belgium
CHR site de la Citadelle
Liège , 04000, Belgium
CHU UCL Namur
Yvoir , 05530, Belgium
Instituto do Cancer do Ceara - ICC
Fortaleza , 60430, Brazil
Hospital de Caridade de Ijui
Ijuí , 98700, Brazil More Info
Principal Investigator
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Hospital Sao Lucas da Pucrs
Porto Alegre , 90610, Brazil
Hospital Nossa Senhora da Conceição
Porto Alegre , 91350, Brazil More Info
Principal Investigator
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Instituto Nacional de Cancer-INCA
Rio De Janeiro , 20231, Brazil
Hospital de Base de Sao Jose do Rio Preto
São José Do Rio Preto , 15090, Brazil
Cross Cancer Institute
Edmonton Alberta, T6G 1, Canada
University Health Network - Princess Margaret Hospital
Toronto Ontario, M5G0A, Canada
Sunnbrook Health Sciences Centre
Toronto Ontario, ON M4, Canada
MUHC-Glen Site and MUHC Research Institute
Montréal Quebec, H4A 3, Canada
Beijing Cancer Hospital
Beijing , 10014, China More Info
Principal Investigator
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Linyi Cancer Hospital
Hangzhou , 31000, China More Info
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The First Affiliated Hospital of Zhejiang University
Hangzou , 31002, China More Info
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Harbin Medical University Cancer Hospital
Heilongjiang , 15008, China More Info
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Jiamusi Cancer Tuberculosis Hospital
Heilongjiang , 15400, China More Info
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Fudan University Shanghai Cancer Center
Henan , 45000, China More Info
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Hubei Cancer Hospital
Hubei , 43007, China More Info
Principal Investigator
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The First Affiliated Hospital of Xi'an Jiaotong University
Shandong , 27600, China More Info
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Henan Cancer Hospital
Shanghai Sheng , 20003, China More Info
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Shanghai Chest Hospital
Shanghai , , China More Info
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Zhejiang Cancer Hospital
Shanxi , 71006, China More Info
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West China Hospital, Sichuan University
Sichuan Province , , China More Info
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Tianjin Medical University Cancer Institute and Hospital
Tianjin , 30006, China More Info
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Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan , 43002, China More Info
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Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Zhejiang , 31001, China More Info
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FN Olomouc â€" Klinika plicnich nemoci a onkologie
Olomouc , 779 0, Czechia More Info
Principal Investigator
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Vseobecna Fakultni Nemocnice VFN
Praha , 12800, Czechia
Hopital Jean Minjoz
Besançon , 25030, France
Hopital Morvan CHU de Brest
Brest , 29200, France More Info
Principal Investigator
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Centre Hospitalier Universitaire de Grenoble
Grenoble , 38043, France
Centre Leon Berard
Lyon , 69008, France
APHM - Hopital Nord
Marseille , 13915, France
University Hospital of Nantes - Thoracic Oncology
Nantes , 44000, France
Institut Curie
Paris , 75248, France
CHU de Poitier Pole regional de Cancerologie
Poitiers , 86000, France
Hopital Pontchaillou
Rennes , 35000, France
Hopitaux Universitaire de Strasbourg
Strasbourg , 67098, France
CHU Toulouse Hopital Larrey
Toulouse , 31059, France
Gustav Roussy Cancer Campus Grand Paris
Villejuif , 94805, France
Charite - Universitaetsmedizin Berlin
Berlin , 10117, Germany
Evangelische Lungenklinik Berlin
Berlin , 13125, Germany
IKF Krankenhaus Nordwest
Frankfurt am main , 60488, Germany
Universitaetsklinikum Freiburg
Freiburg , 79106, Germany More Info
Principal Investigator
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Asklepios Fachklinik Muenchen-Gauting
Gauting , 82131, Germany
Thoraxklinik Heidelberg gGmbH
Heidelberg , 69126, Germany
Lungenklinik Hemer
Hemer , 58675, Germany More Info
Principal Investigator
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Klinikverbund Allgäu
Kempten , 87439, Germany
Universitaet zu Koeln - Uniklinik Koeln
Koeln , 50937, Germany More Info
Principal Investigator
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Medizinische Klinik V
Standort Gießen , , Germany
Klinikum Traunstein
Traunstein , , Germany
Queen Mary Hospital
Hong Kong , 99907, Hong Kong
Prince of Wales Hospital / The Chinese University of Hong Kong
Hong Kong , 99999, Hong Kong
Orszagos Koranyi TBC es Pulmonologiai Intezet
Budapest , 01121, Hungary
Uzsoki Utcai Korhaz
Budapest , 1145, Hungary
Szent Borbala Korhaz
Tatabánya , 02800, Hungary
Tudogyogyintezet Torokbalint
Torokbalint , H-204, Hungary
IRCCS Centro di Riferimento Oncologico
Aviano PN , 33081, Italy More Info
Principal Investigator
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Azienda Ospedaliero- Universitaria Policlinico S. Orsola-Malpighi
Bologna , 40138, Italy
Azienda Ospedaliera Universitaria Policlinico G Rodolico San Marco
Catania , 95030, Italy
ASL 3 Genovese Oncologia Medica Villa Scassi
Genova , 16149, Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milano , 20122, Italy
IRCCS Istituto Europeo di Oncologia
Milano , 20141, Italy
Fondazione IRCCS Istituto Nazionale Tumori
Milan , 20133, Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Orbassano , 10043, Italy
Azienda Ospedaliera Arcispedale Santa Maria Nuova - IRCCS
Reggio Emilia , 42123, Italy More Info
Principal Investigator
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma , 00168, Italy
Instituicao de Fisioterapeutas Ocupacionais
Roma , RM001, Italy
Hyogo Cancer Center
Akashi , 673-8, Japan
Niigata Cancer Center Hospital
Chuo Ku , 951-8, Japan
Kyushu University Hospital
Fukuoka , 812-8, Japan
Saitama Medical University International Medical Center
Hidaka , 350-1, Japan
Kansai Medical University Hospital
Hirakata , 573-1, Japan
Kanazawa University Hospital
Kanazawa , 920-8, Japan
National Cancer Center Hospital East
Kashiwa , 277-8, Japan
The Cancer Institute Hospital of JFCR
Koto-Ku , 135-8, Japan
Kyoto University Hospital
Kyoto , 606-8, Japan
NHO Shikoku Cancer Center
Matsuyama , 791-0, Japan
Shizuoka Cancer Center
Nagaizumi-chō , 411-8, Japan
Aichi Cancer Center Hospital
Nagoya-shi , 464-8, Japan More Info
Principal Investigator
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Okayama University Hospital
Okayama , 36927, Japan
Osaka City General Hospital
Osaka-shi , 534-0, Japan
Osaka International Cancer Institute
Osaka , 541-8, Japan
Saitama Cancer Center
Saitama , 362-0, Japan
Sendai Kousei Hospital
Sendai-shi , 980-0, Japan
NHO Hokkaido Cancer Center
Shiroishi , 003-0, Japan
Tokushima University Hospital
Tokushima , 770-8, Japan
National Cancer Center Hospital
Tokyo , 104-0, Japan
Fujita Health University Hospital
Toyoake , 470-1, Japan
Kindai University Hospital
Ōsaka-sayama , 589-8, Japan
Chungbuk National University Hospital
Cheongju-si , 28644, Korea, Republic of
Kyungpook National University Chilgok Hospital
Daegu , 41404, Korea, Republic of
St. Vincents Hospital The Catholic University of Korea
Gyeonggi-do , 16247, Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si , 13620, Korea, Republic of
Kangbuk Samsung Hospital
Seoul , 03181, Korea, Republic of
Yonsei University Health System - Severance Hospital
Seoul , 03722, Korea, Republic of
Asan Medical Center
Seoul , 05505, Korea, Republic of
Samsung Medical Center
Seoul , 06351, Korea, Republic of
The Catholic University of Korea, Seoul St. Marys Hospital
Seoul , 06591, Korea, Republic of
Seoul National University Boramae Medical Center
Seoul , 07061, Korea, Republic of
San Peregrino Cancer Center
Aguascalientes , 20230, Mexico
Hospital Medica Sur Tlalpan
Ciudad de mexico , 14050, Mexico
Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara , 44280, Mexico
Hospital Universitario Jose Eleuterio Gonzalez
Monterrey , 64460, Mexico
Erasmus MC
Amsterdam , 3000 , Netherlands
Amphia Ziekenhuis
Breda , 4818 , Netherlands
Isala Klinieken
Harderwijk , 3844 , Netherlands
St. Jansdal Ziekenhuis
Rotterdam , 3015 , Netherlands
II Klinika Chorob Pluc i Gruzlicy
Białystok , 15-27, Poland
Szpitale Pomorskie Sp.zo.o
Gdynia , 81-51, Poland
Ms Pneumed
Lublin , 20-09, Poland
SP Zespol Gruzlicy i Chorob Pluc
Olsztyn , 10-35, Poland
Med Polonia Sp. z o.o.
Poznań , 60-69, Poland
Szpital Specjalistyczny w Prabutach Sp. z o.o.
Prabuty , 82-55, Poland
Oddział Onkologii Wojewódzki Szpital Specjalistyczny Słupsk
Słupsk , 76-20, Poland
Magodent Sp. z.o.o Szpital Elblaska
Warsaw , 01-74, Poland
Maria Sklodowska-Curie National Research Institute of Oncology
Warsaw , 02-78, Poland
FDI Clinical Research
San Juan , 00927, Puerto Rico
SC Oncopremium Team SRL
Baia Mare , 43029, Romania More Info
Principal Investigator
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Centrul Medical Sanador
Bucharest , 20125, Romania
Institutul Oncologic Profesor Doctor Alexandru Trestioreanu
Bucuresti , 02232, Romania More Info
Principal Investigator
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Clinical Emergency Hospital
Constanţa , 90059, Romania More Info
Principal Investigator
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Onco Clinic Consult SA
Craiova , 20010, Romania More Info
Principal Investigator
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Sf Nectarie Oncology Center
Craiova , 20034, Romania More Info
Principal Investigator
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Oncolab SRL
Craiova , 20038, Romania More Info
Principal Investigator
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SC Oncomed SRL
Timişoara , 30042, Romania More Info
Principal Investigator
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Kursk Regional Clinical Oncology Dispensary
Kursk , 30552, Russian Federation
Federal State Budgetary Institution - N.N. Blokhin National Medical Research Center of Oncology
Moscow , 11547, Russian Federation
University Headache Clinic LLC
Moscow , 12146, Russian Federation
VitaMed LLC
Moscow , 12951, Russian Federation
Institute of Oncology Hadassah Moscow
Moscow , , Russian Federation
LLC MSCH "Klinitsist"
Novosibirsk , 63009, Russian Federation
N.N. Petrov Research Institute of Oncology
Saint Petersburg , 19775, Russian Federation
National Cancer Centre Singapore
Singapore , 16961, Singapore
ICON Cancer Centre Farrer Park Hospital
Singapore , 21756, Singapore
OncoCare Cancer Centre - Gleneagles Medical Centre Location
Singapore , 25849, Singapore
Hospital de la Santa Creu i Sant Pau
Barcelona , 08025, Spain
Hospital Clinic i Provincial de Barcelona
Barcelona , 08036, Spain
Hospital Universitario Vall d'Hebron
Barcelona , 80350, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid , 28040, Spain
Hospital Universitario 12 de Octubre
Madrid , 28041, Spain
Hospital Puerte de Hierro de Majadahonda
Madrid , 28222, Spain
Hospital Regional Universitario Málaga
Málaga , 29010, Spain
CHUO
Ourense , 32005, Spain
Hospital Virgen Macarena
Sevilla , 41007, Spain
Hospital Universitario de Valme
Sevilla , 41014, Spain
Hospital General Universitario de Valencia
Valencia , 46014, Spain
Hospital Universitari i Politecnic La Fe
Valencia , 46026, Spain
Hospital Clinico Universitario Lozano Bleza
Zaragoza , 50009, Spain
Inselspital Universitätsspital Bern
Bern , 3010, Switzerland
Kantonsspital St. Gallen
Saint Gallen , 9007, Switzerland
Stadtspital Waid ; Triemli, Site Triemli - clinic for Medical oncology & hematology
Zürich , 8063, Switzerland
E-Da Hospital
Kaohsiung City , 00824, Taiwan
Chang Gung Memorial Hospital CGMH - Kaohsiung Branch
Niaosong , 00833, Taiwan
Chung Shan Medical University Hospital
Taichung , 00420, Taiwan
Taichung Veterans General Hospital
Taichung , 40705, Taiwan
National Cheng Kung University Hospital NCKUH
Tainan , 00704, Taiwan
Chi Mei Medical Center CMMC - Liouying Branch
Tainan , 00736, Taiwan
National Taiwan University Hospital NTUH
Taipei , 00100, Taiwan
LinKou Chang Gung Memorial Hospital
Taoyuan , 333, Taiwan
Clatterbridge Cancer Centre
Liverpool , L7 8Y, United Kingdom More Info
Principal Investigator
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University College Hospital
London , NW1 2, United Kingdom
The Christie Hospital
Manchester , M20 4, United Kingdom
The James Cook University Hospital
Middlesbrough , TS4 3, United Kingdom
Portsmouth Hospitals University NHS Trust
Portsmouth , PO6 3, United Kingdom More Info
Principal Investigator
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How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

590

Study ID:

NCT04656652

Recruitment Status:

Recruiting

Sponsor:


Daiichi Sankyo, Inc.

How clear is this clinincal trial information?

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