Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

ACTIVE NOT RECRUITING

NCT04656652

PHASE3

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)

Sponsor: Daiichi Sankyo

View on ClinicalTrials.gov

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.

Official title: Phase 3 Randomized Study of DS-1062a Versus Docetaxel in Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer (TROPION-LUNG01)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

605

Start Date

2020-12-21

Completion Date

2027-02-15

Last Updated

2026-03-24

Healthy Volunteers

Conditions

Non-small Cell Lung Cancer

Interventions

DRUG

DS-1062a

DS-1062a will be administered as an intravenous (IV) infusion on Day 1 of each 3-week cycle

DRUG

Docetaxel

Docetaxel will be administered as an IV infusion on Day 1 of each 3-week cycle.

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: 1. Must have documented negative test results for epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK). 2. 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: 1. 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. 2. 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: 1. 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 tyrosine kinase inhibitor (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. 2. 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. 3. 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

Locations (209)

Ironwood Cancer and Research Center

Chandler, Arizona, United States

St. Joseph Heritage Healthcare

Anaheim, California, United States

The Oncology Institute of Hope and Innovation

Glendale, California, United States

University of California San Diego

La Jolla, California, United States

UCLA

Los Angeles, California, United States

PIH Health

Whittier, California, United States

Memorial Healthcare System- Memorial Cancer Institute

Hollywood, Florida, United States

Orlando Health

Orlando, Florida, United States

Florida Cancer Specialists

Tallahassee, Florida, United States

Northwestern University

Chicago, Illinois, United States

University of Chicago

Chicago, Illinois, United States

Ft. Wayne Medical Oncology and Hematology

Fort Wayne, Indiana, United States

Baptist Health Louisville

Louisville, Kentucky, United States

Baton Rouge General

Baton Rouge, Louisiana, United States

American Oncology Partners of Maryland

Bethesda, Maryland, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

OptumCare Cancer Care

Las Vegas, Nevada, United States

Meridian Hematology and Oncology

Manahawkin, New Jersey, United States

Astera Cancer Care

Somerset, New Jersey, United States

Montefiore Medical Center

The Bronx, New York, United States

Messino Cancer Centers

Asheville, North Carolina, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Roger Williams Medical Center

Providence, Rhode Island, United States

Avera Cancer Institute

Sioux Falls, South Dakota, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

The Center for Cancer and Blood Disorders

Fort Worth, Texas, United States

Utah Cancer Specialists

Salt Lake City, Utah, United States

University of Virginia Health System

Charlottesville, Virginia, United States

Virginia Cancer Specialist

Fairfax, Virginia, United States

Kadlec Clinic Hematology and Oncology

Kennewick, Washington, United States

Northwest Medical Specialties

Tacoma, Washington, United States

CER San Juan

Buenos Aires, Argentina

Centro de Investigacion Pergamino S.A.

Pergamino, Argentina

Instituto de OncologÃƒÂ-a de Rosario

Rosario, Argentina

Gaston Martinengo

Rosario, Argentina

Flinders Medical Centre

Bedford Park, Australia

Blacktown Hosital

Blacktown, Australia

Austin Hospital

Heidelberg, Australia

Macquarie Hospital

North Ryde, Australia

Crown Princess Mary Cancer Centre Westmead Hospital

Sydney, Australia

Southern Medical Day Care Centre

Wollongong, Australia

Centre Hospitalier Jolimont-Lobbes

Haine-Saint-Paul, Belgium

CHA Centre Hospitalier de l Ardenne

Libramont, Belgium

CHR site de la Citadelle

Liège, Belgium

CHU UCL Namur

Yvoir, Belgium

Instituto do Cancer do Ceara - ICC

Fortaleza, Brazil

Hospital Sao Lucas da Pucrs

Porto Alegre, Brazil

Hospital Nossa Senhora da Conceição

Porto Alegre, Brazil

Instituto Nacional de Cancer-INCA

Rio de Janeiro, Brazil

Hospital de Base de Sao Jose do Rio Preto

São José do Rio Preto, Brazil

Cross Cancer Institute

Edmonton, Alberta, Canada

University Health Network - Princess Margaret Hospital

Toronto, Ontario, Canada

Sunnbrook Health Sciences Centre

Toronto, Ontario, Canada

MUHC-Glen Site and MUHC Research Institute

Montreal, Quebec, Canada

Beijing Cancer Hospital

Beijing, China

Hunan Cancer Hospital

Changsha, China

Xiangya Hospital central south university

Changsha, China

Linyi Cancer Hospital

Hangzhou, China

The First Affiliated Hospital of Zhejiang University

Hangzou, China

Harbin Medical University Cancer Hospital

Heilongjiang, China

Jiamusi Cancer Tuberculosis Hospital

Heilongjiang, China

Fudan University Shanghai Cancer Center

Henan, China

Hubei Cancer Hospital

Hubei, China

Jiangsu Province Hospital

Nanjing, China

The First Affiliated Hospital of Xi'an Jiaotong University

Shandong, China

Shanghai Chest Hospital

Shanghai, China

Henan Cancer Hospital

Shanghai Sheng, China

Zhejiang Cancer Hospital

Shanxi, China

West China Hospital, Sichuan University

Sichuan Province, China

Tianjin Medical University Cancer Institute and Hospital

Tianjin, China

Affiliated Cancer Hospital of Xinjiang Medical University

Ürümqi, China

Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology

Wuhan, China

Sir Run Run Shaw Hospital Zhejiang University School of Medicine

Zhejiang, China

Vseobecna Fakultni Nemocnice VFN

Prague, Czechia

Hopital Jean Minjoz

Besançon, France

Centre Hospitalier Universitaire de Grenoble

Grenoble, France

Centre Leon Berard

Lyon, France

CHU Louis Pradel

Lyon, France

APHM - Hopital Nord

Marseille, France

University Hospital of Nantes - Thoracic Oncology

Nantes, France

Institut Curie

Paris, France

CHU de Poitier Pole regional de Cancerologie

Poitiers, France

Hopital Pontchaillou

Rennes, France

Hopitaux Universitaire de Strasbourg

Strasbourg, France

Hopital Foch

Sureesnes, France

CHU Toulouse Hopital Larrey

Toulouse, France

Gustav Roussy Cancer Campus Grand Paris

Villejuif, France

Charite - Universitaetsmedizin Berlin

Berlin, Germany

Evangelische Lungenklinik Berlin

Berlin, Germany

Universitaet zu Koeln - Uniklinik Koeln

Cologne, Germany

IKF Krankenhaus Nordwest

Frankfurt am Main, Germany

Universitaetsklinikum Freiburg

Freiburg im Breisgau, Germany

Asklepios Fachklinik Muenchen-Gauting

Gauting, Germany

Thoraxklinik Heidelberg gGmbH

Heidelberg, Germany

Lungenklinik Hemer

Hemer, Germany

Klinikverbund AllgÃ¤u

Kempten, Germany

Medizinische Klinik V

Standort Gießen, Germany

Klinikum Traunstein

Traunstein, Germany

Queen Mary Hospital

Hong Kong, Hong Kong

Prince of Wales Hospital / The Chinese University of Hong Kong

Hong Kong, Hong Kong

Orszagos Koranyi TBC es Pulmonologiai Intezet

Budapest, Hungary

Uzsoki Utcai Korhaz

Budapest, Hungary

Szent Borbala Korhaz

Tatabánya, Hungary

Tolna Megyei Balassa Janos Korhaz

Tolna, Hungary

Tudogyogyintezet Torokbalint

Törökbálint, Hungary

Azienda Ospedaliero- Universitaria Policlinico S. Orsola-Malpighi

Bologna, Italy

Azienda Ospedaliera Universitaria Policlinico G Rodolico San Marco

Catania, Italy

ASL 3 Genovese Oncologia Medica Villa Scassi

Genova, Italy

Fondazione IRCCS Istituto Nazionale Tumori

Milan, Italy

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

Milan, Italy

IRCCS Istituto Europeo di Oncologia

Milan, Italy

Azienda Ospedaliero-Universitaria San Luigi Gonzaga

Orbassano, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Italy

Instituicao de Fisioterapeutas Ocupacionais

Roma, Italy

Hyogo Cancer Center

Akashi, Japan

Niigata Cancer Center Hospital

Chūōku, Japan

Kyushu University Hospital

Fukuoka, Japan

Saitama Medical University International Medical Center

Hidaka, Japan

Kansai Medical University Hospital

Hirakata, Japan

Kanazawa University Hospital

Kanazawa, Japan

National Cancer Center Hospital East

Kashiwa, Japan

The Cancer Institute Hospital of JFCR

Kōtoku, Japan

Kyoto University Hospital

Kyoto, Japan

NHO Shikoku Cancer Center

Matsuyama, Japan

Shizuoka Cancer Center

Nagaizumi-chō, Japan

Okayama University Hospital

Okayama, Japan

Osaka City General Hospital

Osaka, Japan

Osaka International Cancer Institute

Osaka, Japan

Kindai University Hospital

Ōsaka-sayama, Japan

Saitama Cancer Center

Saitama, Japan

Sendai Kousei Hospital

Sendai, Japan

NHO Hokkaido Cancer Center

Shiroishi, Japan

Tokushima University Hospital

Tokushima, Japan

National Cancer Center Hospital

Tokyo, Japan

Fujita Health University Hospital

Toyoake, Japan

San Peregrino Cancer Center

Aguascalientes, Mexico

Hospital Civil de Guadalajara Fray Antonio Alcalde

Guadalajara, Mexico

Hospital Medica Sur Tlalpan

Mexico City, Mexico

Hospital Universitario Jose Eleuterio Gonzalez

Monterrey, Mexico

Erasmus MC

Amsterdam, Netherlands

Amphia Ziekenhuis

Breda, Netherlands

Isala Klinieken

Harderwijk, Netherlands

St. Jansdal Ziekenhuis

Rotterdam, Netherlands

II Klinika Chorob Pluc i Gruzlicy

Bialystok, Poland

Szpitale Pomorskie Sp.zo.o

Gdynia, Poland

Ms Pneumed

Lublin, Poland

SP Zespol Gruzlicy i Chorob Pluc

Olsztyn, Poland

Med Polonia Sp. z o.o.

Poznan, Poland

Szpital Specjalistyczny w Prabutach Sp. z o.o.

Prabuty, Poland

Oddział Onkologii Wojewódzki Szpital Specjalistyczny Słupsk

Słupsk, Poland

Magodent Sp. z.o.o Szpital Elblaska

Warsaw, Poland

Maria Sklodowska-Curie National Research Institute of Oncology

Warsaw, Poland

FDI Clinical Research

San Juan, Puerto Rico

SC Oncopremium Team SRL

Baia Mare, Romania

Institutul Oncologic Profesor Doctor Alexandru Trestioreanu

Bucharest, Romania

Centrul Medical Sanador

Bucharest, Romania

Clinical Emergency Hospital

Constanța, Romania

Onco Clinic Consult SA

Craiova, Romania

Sf Nectarie Oncology Center

Craiova, Romania

Oncolab SRL

Craiova, Romania

SC Oncomed SRL

Timișoara, Romania

Kursk Regional Clinical Oncology Dispensary

Kursk, Russia

Federal State Budgetary Institution - N.N. Blokhin National Medical Research Center of Oncology

Moscow, Russia

University Headache Clinic LLC

Moscow, Russia

VitaMed LLC

Moscow, Russia

Institute of Oncology Hadassah Moscow

Moscow, Russia

LLC MSCH "Klinitsist"

Novosibirsk, Russia

N.N. Petrov Research Institute of Oncology

Saint Petersburg, Russia

National Cancer Centre Singapore

Singapore, Singapore

ICON Cancer Centre Farrer Park Hospital

Singapore, Singapore

OncoCare Cancer Centre - Gleneagles Medical Centre Location

Singapore, Singapore

Chungbuk National University Hospital

Cheongju-si, South Korea

Kyungpook National University Chilgok Hospital

Daegu, South Korea

St. Vincents Hospital The Catholic University of Korea

Gyeonggi-do, South Korea

Seoul National University Bundang Hospital

Seongnam-si, South Korea

Kangbuk Samsung Hospital

Seoul, South Korea

Yonsei University Health System - Severance Hospital

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

The Catholic University of Korea, Seoul St. Marys Hospital

Seoul, South Korea

Seoul National University Boramae Medical Center

Seoul, South Korea

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Hospital Clinic i Provincial de Barcelona

Barcelona, Spain

Hospital Universitario Vall d'Hebron

Barcelona, Spain

Hospital Universitario Fundacion Jimenez Diaz

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Puerte de Hierro de Majadahonda

Madrid, Spain

Hospital Regional Universitario Málaga

Málaga, Spain

CHUO

Ourense, Spain

Hospital Virgen Macarena

Seville, Spain

Hospital Universitario de Valme

Seville, Spain

Hospital General Universitario de Valencia

Valencia, Spain

Hospital Universitari i Politecnic La Fe

Valencia, Spain

Hospital Clinico Universitario Lozano Bleza

Zaragoza, Spain

Inselspital UniversitÃ¤tsspital Bern

Bern, Switzerland

Kantonsspital St. Gallen

Sankt Gallen, Switzerland

Stadtspital Waid ; Triemli, Site Triemli - clinic for Medical oncology & hematology

Zurich, Switzerland

E-Da Hospital

Kaohsiung City, Taiwan

Chang Gung Memorial Hospital CGMH - Kaohsiung Branch

Niaosong, Taiwan

Chung Shan Medical University Hospital

Taichung, Taiwan

Taichung Veterans General Hospital

Taichung, Taiwan

National Cheng Kung University Hospital NCKUH

Tainan, Taiwan

Chi Mei Medical Center CMMC - Liouying Branch

Tainan, Taiwan

National Taiwan University Hospital NTUH

Taipei, Taiwan

LinKou Chang Gung Memorial Hospital

Taoyuan District, Taiwan

University College Hospital

London, United Kingdom

The Christie Hospital

Manchester, United Kingdom

The James Cook University Hospital

Middlesbrough, United Kingdom

Clinical Research Directory

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

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (209)