Lung Cancer Clinical Trial

A Study of Ifinatamab Deruxtecan Versus Treatment of Physician’s Choice in Subjects With Relapsed Small Cell Lung Cancer

Summary

This study was designed to compare the efficacy and safety of I-DXd with treatment of physician's choice in participants with relapsed small cell lung cancer (SCLC).

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Full Description

The primary objective of this study is to assess whether treatment with I-DXd improves objective response rate (ORR) and prolongs overall survival (OS) compared with treatment of physician's choice among participants with relapsed SCLC.

The secondary objectives of the study are to further evaluate the efficacy/safety of I-DXd, health economics and outcome research measures (including patient reported outcomes), immunogenicity of I-DXd, B7-H3 protein expression, and characterize the pharmacokinetics of I-DXd.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria

Participants must meet all the following criteria to be eligible for randomization into the study:

Sign and date the informed consent form prior to the start of any study-specific qualification procedures.
Adults ≥18 years or the minimum legal adult age (whichever is greater) at the time the informed consent form is signed.
Has histologically or cytologically documented SCLC.
The participant must provide adequate baseline tumor samples with sufficient quantity and quality of tumor tissue content.
Has received prior therapy with only one prior platinum-based line as systemic therapy for SCLC with at least 2 cycles of therapy and a chemotherapy-free interval of >30 days.
Has at least 1 measurable lesion according to RECIST v1.1 as assessed by the investigator.
Has documentation of radiological disease progression on or after the most recent systemic therapy.
Has ECOG PS of ≤1.
Subjects with untreated and asymptomatic brain metastases or subjects with treated brain metastases that are no longer symptomatic (ie, without neurologic signs or symptoms) and who require no treatment with steroids or anticonvulsants may be included in the study if they have recovered from the acute toxic effect of radiotherapy. Subjects must have a stable neurologic status for at least 2 weeks prior to the first dose of study drug.

Exclusion Criteria

Participants who meet any of the following criteria will be disqualified from entering the study:

Has received prior treatment with orlotamab, enoblituzumab, or other humanized anti-B7 homologue 3 (B7-H3) targeted agents, including I-DXd.
Prior discontinuation of an antibody drug conjugate (ADC) that consists of an exatecan derivative (eg, trastuzumab deruxtecan) due to treatment-related toxicities.
Has received any of the comparators used in this study or any topoisomerase I inhibitor.
Has inadequate washout period before randomization as specified in the protocol.
Has any of the following conditions within the past 6 months: cerebrovascular accident, transient ischemic attack, or another arterial thromboembolic event.
Has uncontrolled or significant cardiovascular disease.
Has clinically significant corneal disease.
Has history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required corticosteroids, current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at Screening.
Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses, including, but not limited to, any underlying pulmonary disorder and potential pulmonary involvement caused by any autoimmune, connective tissue, or inflammatory disorders, prior pneumonectomy, or requirement for supplemental oxygen.

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

468

Study ID:

NCT06203210

Recruitment Status:

Not yet recruiting

Sponsor:

Daiichi Sankyo

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There are 197 Locations for this study

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Highlands Oncology Group
Springdale Arkansas, 72762, United States
Providence Medical Foundation
Fullerton California, 92835, United States
David Geffen School of Medicine
Los Angeles California, 90095, United States
University of Miami Hospital and Clinics Sylvester Comprehensive Cancer Center
Miami Florida, 33136, United States
Adventhealth Cancer Insitute
Orlando Florida, 32804, United States
H. Lee Moffitt Cancer Center and Research Institute, Inc
Tampa Florida, 33612, United States
Rush University Medical Center
Chicago Illinois, 60612, United States
Baptist Health Lexington
Lexington Kentucky, 40503, United States
University of Maryland Medical Group
Baltimore Maryland, 21201, United States
John Hopkins School of Medicine
Baltimore Maryland, 21287, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02216, United States
Henry Ford Health System
Detroit Michigan, 48202, United States
Mercy Clinic Oncology and Hematology Sindelar Cancer Center
Saint Louis Missouri, 63128, United States
Nebraska Educational Biomedical Research Association
Omaha Nebraska, 68105, United States
Dartmouth-Hitchcock Medical Center
Lebanon New Hampshire, 03766, United States
Astera Cancer Care
East Brunswick New Jersey, 08816, United States
Meridian Health Systems
Neptune New Jersey, 07753, United States
Montefiore Medical Center Prime
Bronx New York, 10461, United States
Clinical Research Alliance, Inc
Lake Success New York, 11042, United States
New York University Cancer Center - Laura and Isaac Perlmutter Cancer Center At Nyu Langone
Mineola New York, 11501, United States
Duke University Health System
Durham North Carolina, 27703, United States
Mercy Medical Center
Canton Ohio, 44708, United States
Providence Portland Medical Center
Portland Oregon, 97213, United States
The West Clinic
Germantown Tennessee, 38138, United States
Houston Methodist Cancer Center
Houston Texas, 77030, United States
University of Texas Md Anderson Cancer Center
Houston Texas, 77030, United States
Texas Oncology, P.A. - Tyler
Tyler Texas, 75702, United States
Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States
Ballarat Base Hospital
Ballarat , 3350, Australia
Chris Oâ Brien Lifehouse
Camperdown , 2050, Australia
Sunshine Hospital
St Albans , 3021, Australia
St John of God Subiaco Hospital
Subiaco , 6008, Australia
Townsville Cancer Centre
Townsville , 4814, Australia
Princess Alexandra Hospital
Woolloongabba , 4102, Australia
Cliniques Universitaires Saint-Luc
Brussels , 1200, Belgium
UZA
Edegem , 2650, Belgium
Jessa Ziekenhuis Hospital
Hasselt , 3500, Belgium
Chu de Liă Ge
Liege , 4000, Belgium
AZ DELTA
Roeselare , 8800, Belgium
Chu Ucl Namur
Yvoir , 5530, Belgium
Hospital de Că'Ncer de Barretos - Fundaă Ă O Pio Xii
Barretos , 14784, Brazil
Cepon - Centro de Pesquisas Oncolă"Gicas de Santa Catarina
FlorianĂłpolis , 88034, Brazil
Clínica de Neoplasias Litoral Ltda.
ItajaĂ- , 88301, Brazil
Hospital São Lucas Da Pucrs
Porto Alegre , 90610, Brazil
Cepho - Centro de Estudos E Pesquisas de Hematologia E Oncologia
Santo Andre , 09060, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto
Sao Jose Rio Preto , 15090, Brazil
Icesp - Instituto Do Câncer Do Estado de São Paulo Octavio Frias de Oliveira
SĂŁo Paulo , 01246, Brazil
Hospital Sirio-Libanes
SĂŁo Paulo , 01308, Brazil
Hospital Benefică Ncia Portuguesa de Să O Paulo
SĂŁo Paulo , 01323, Brazil
A. C. Camargo Cancer Center
SĂŁo Paulo , 01509, Brazil
Queen Elizabeth Ii Health Sciences Centre
Halifax , B3H 1, Canada
Princess Margaret Cancer Center
Toronto , M5G 2, Canada
Beijing Cancer Hospital
Beijing , 10014, China
Beijing Chest Hospital,Capital Medical University
Beijing , 10114, China
Jilin Province Tumor Hospital
Changchun , 13001, China
Hunan Cancer Hospital
Changsha , 41001, China
Sichuan Cancer Hospital
Chengdu , 61004, China
West China Hospital, Sichuan University
Chengdu , 61004, China
Chongqing University Cancer Hospital
Chongqing , 40003, China
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou , 31000, China
Zhejiang Cancer Hospital
Hangzhou , 31002, China
Harbin Medical University Cancer Hospital
Harbin , 15008, China
Shandong Cancer Hospital
Jinan , 25011, China
Linyi Cancer Hospital
Linyi , 27600, China
The Second Peoples Hospital of Neijiang
Neijiang , 64100, China
Fudan University Shanghai Cancer Center
Shanghai , 20003, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin , 30006, China
The Affiliated Cancer Hospital of Xinjiang Medical University
Urumqi , 83000, China
Hubei Cancer Hospital
Wuhan , 43000, China
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan , 43002, China
The First Affiliated Hospital of Xiâ An Jiaotong University
Xi'an , 71006, China
Xiangyang Central Hospital
Xiangyang , 44102, China
Yantai Yuhuangding Hospital
Yantai , 26400, China
Henan Cancer Hospital
Zhengzhou , 45000, China
Institut Sainte Catherine
Avignon Cedex 9 , 84918, France
Chu Bordeaux
Bordeaux cedex , 33075, France
Centre Hospitalier Intercommunal de Cră Teil
Creteil Cedex , 94010, France
Hopital Albert Calmette - Chu Lille
Lille Cedex , 59037, France
Chu Limoges - Hopital Du Cluzeau
Limoges cedex , 87042, France
Centre Léon Bérard
Lyon , 69008, France
Assistance Publique-Hă"Pitaux de Marseille
Marseille , 13005, France
Hopital Arnaud de Villeneuve
Montpellier cedex 05 , 34295, France
Institut Régional Du Cancer de Montpellier
Montpellier , 34298, France
Ch de Mulhouse - Hă"Pital Emile Muller
Mulhouse Cedex , 68100, France
Institut Curie - Site de Paris
Paris Cedex 05 , 75005, France
Hopital Tenon
Paris , 75020, France
Chu Rennes - Hopital Pontchaillou
Rennes cedex 09 , 35000, France
Chu Nantes - Hă"Pital Guillaume Et Renă Laă
Saint Herblain , 44805, France
Institut de Cancerologie de La Loire
Saint-Priest-En-Jarez , 42270, France
Hă"Pital Foch
Suresnes Cedex , 92151, France
Institut Gustave Roussy
Villejuif cedex , 94805, France
Evangelische Lungenklinik Berlin
Berlin , 13125, Germany
Helios Klinikum Erfurt
Erfurt , 99089, Germany
Universtitaetsklinikum Essen
Essen , 45147, Germany
Universitaetsklinikum Frankfurt Goethe-Universitaet
Frankfurt am Main , 60590, Germany
Krankenhaus Nordwest Gmbh
Frankfurt , 60488, Germany
Asklepios Fachkliniken Muenchen-Gauting
Gauting , 82131, Germany
Srh Wald-Klinikum Gera Gmbh
Gera , 7548, Germany
Universitaetsklinikum Giessen Und Marburg Gmbh Standort Giessen
Giessen , 35392, Germany
Asklepios Klinik Harburg
Hamburg , 21075, Germany
Lki Lungenfachklinik Immenhausen
Immenhausen/Krs. Kassel , 34376, Germany
Staedtisches Krankenhaus Kiel
Kiel , 24116, Germany
Johannes Wesling Klinikum Minden
Minden , 32429, Germany
Pius-Hospital Oldenburg
Oldenburg , 26121, Germany
Universitaetsklinikum Ulm
Ulm , 89081, Germany
Semmelweis Egyetem
Budapest , 1088, Hungary
Orszagos Koranyi Pulmonologiai Intezet
Budapest , 1121, Hungary
Orszagos Onkologiai Intezet
Budapest , 1122, Hungary
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Gyor , 9024, Hungary
Bacs-Kiskun Varmegyei Oktatokorhaz
Kecskemet , 6000, Hungary
Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari
Bari , 70124, Italy
Humanitas Gavazzeni
Bergamo , 24125, Italy
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia (Presidio Spedali Civili)
Brescia , 25124, Italy
Azienda Ospedaliera Universitaria Policlinico - Vittorio Emanuele (Presidio Gaspare Rodolico)
Catania , 95123, Italy
Azienda Ospedaliero Universitaria Mater Domini
Catanzaro , 88100, Italy
Istituto Nazionale Per La Ricerca Sul Cancro Di Genova
Genova , 16132, Italy
Ospedale San Raffaele
Milano , 20132, Italy
Fondazione Irccs Istituto Nazionale Dei Tumori
Milano , 20133, Italy
Ieo Istituto Europeo Di Oncologia
Milano , 20141, Italy
Azienda Socio Sanitaria Territoriale Di Monza (Presidio San Gerardo)
Monza , 20900, Italy
Azienda Ospedaliera Universitaria- Universită Degli Studi Della Campania  Luigi Vanvitelliâ
Napoli , 80131, Italy
Azienda Ospedaliero Universitaria Di Parma
Parma , 43100, Italy
Azienda Ospedaliera Di Perugia Ospedale S. Maria Della Misericordia
Perugia , 06129, Italy
Istituto Nazionale Tumori Regina Elena Irccs
Roma , RM001, Italy
Istituto Clinico Humanitas
Rozzano , 20089, Italy
Centro Ricerche Cliniche Di Verona S.R.L.
Verona , 37134, Italy
National Cancer Center Hospital
Chuo-ku , 104-0, Japan
Kyushu University Hospital
Fukuoka , 812-8, Japan
National Cancer Center Hospital East
Kashiwa , 277-8, Japan
The Cancer Institute Hospital of Jfcr
Koto-ku , 135-8, Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama , 791-0, Japan
Okayama University Hospital
Okayama , 700-8, Japan
Kindai University Hospital
Osaka-Sayama , 589-8, Japan
Kitasato University Hospital
Sagamihara , 252-0, Japan
National Hospital Organization Hokkaido Cancer Center
Sapporo , 003-0, Japan
Shizuoka Cancer Center
Sunto-gun , 411-8, Japan
Osaka Medical and Pharmaceutical University Hospital
Takatsuki , 569-8, Japan
Wakayama Medical University Hospital
Wakayama , 641-8, Japan
Chungbuk National University Hospital
Cheongju , 28644, Korea, Republic of
Kyungpook National University Chilgok Hospital
Daegu , 41404, Korea, Republic of
National Cancer Center
Goyan-si , 10408, Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si , 13620, Korea, Republic of
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul , 03722, Korea, Republic of
Samsung Medical Center
Seoul , 06351, Korea, Republic of
Asan Medical Center
Seoul , 5505, Korea, Republic of
The Catholic University of Korea, St. Vincent'S Hospital
Suwon-si , 16247, Korea, Republic of
Jeroen Bosch Ziekenhuis
's Hertogenbosch , 5223 , Netherlands
Netherlands Cancer Institute
Amsterdam , 1066 , Netherlands
Maastricht University Medical Center
Maastricht , 6229 , Netherlands
Etz Elisabeth
Tilburg , 5022 , Netherlands
Krakowski Szpital Specjalistyczny Im. Jana Pawla Ii
Krakow , 31-20, Poland
Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy
Otwock , 05-40, Poland
Szpital Specjalistyczny W Prabutach
Prabuty , 82-55, Poland
Provita Prolife
Tomaszow Mazowiecki , 97-20, Poland
Centro Hospitalar E Universită Rio de Coimbra E.P.E.
Coimbra , 3000-, Portugal
Hospital Da Senhora Da Oliveira Guimară Es
Guimarães , 4835-, Portugal
Hospital Da Luz
Lisboa , 1500-, Portugal
Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital Pulido Valente
Lisboa , 1769-, Portugal
Institutul Oncologic 'Prof. Dr. Ion Chiricuta' Cluj Napoca
Cluj Napoca , 40001, Romania
S.C Radiotherapy Center Cluj S.R.L
Comuna Floresti , 40728, Romania
S.C Centrul de Oncologie Sfantul Nectarie Craiova
Craiova , 20074, Romania
S.C. Sigmedical Services Srl
Suceava , 72021, Romania
Hospital Clinic de Barcelona
Barcelona , 08036, Spain
Hospital de La Santa Creu I Sant Pau
Barcelona , 8025, Spain
Hospital Universitari Vall D'Hebron
Barcelona , 8035, Spain
Hospital Universitario Reina Sofia
Cordoba , 14004, Spain
Hospital Universitario Ciudad de Jaen
Jaen , 23007, Spain
Hospital de Especialidades de Jerez de La Frontera
Jerez De Frontera , 11408, Spain
Ico L'Hospitalet - Hospital Duran I Reynals
L'Hospitalet de Llobregat , 08908, Spain
Complejo Hospitalario Universitario Insular Materno-Infantil
Las Palmas de Gran Canaria , 35016, Spain
Hospital General Universitario Gregorio Marañon
Madrid , 28007, Spain
Hospital Universitario Ramon Y Cajal
Madrid , 28034, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid , 28040, Spain
Hospital Regional Universitario de Malaga
MĂĄlaga , 29010, Spain
Hospital Universitario Virgen Macarena
Sevilla , 41009, Spain
Hospital Universitario Virgen Del Rocio
Sevilla , 41013, Spain
Inselspital - Universitaetsspital Bern
Bern , 3010, Switzerland
Hfr Fribourg/Kantonsspital Fribourg
Fribourg , 1700, Switzerland
Kantonsspital St. Gallen
St. Gallen , 9007, Switzerland
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City , 80756, Taiwan
China Medical University Hospital
Taichung , 40432, Taiwan
Taichung Veterans General Hospital
Taichung , 40705, Taiwan
National Cheng Kung University Hospitalx
Tainan , 70403, Taiwan
National Taiwan University Cancer Centre
Taipei , 10048, Taiwan
Taipei Medical University Hospital
Taipei , 11030, Taiwan
Chang Gung Memorial Hospital
Taoyuan County , 333, Taiwan
Taipei Veterans General Hospital
Tapei , 11217, Taiwan
Dr. Abdurrahman Yurtaslan Oncology Teaching and Research Hospital
Ankara , 06105, Turkey
Ankara City Hospital
Ankara , 06800, Turkey
Dicle University, Medical Faculty
Diyarbakir , 21080, Turkey
Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty
Istanbul , 34098, Turkey
Medipol University Medical Faculty
Istanbul , 34214, Turkey
Goztepe Prof. Dr. Suleyman Yalcin City Hospital
Istanbul , 34722, Turkey
Izmir Medicalpark Hospital
Izmir , 35530, Turkey
Birmingham Heartlands Hospital
Birmingham , B9 5S, United Kingdom
St James'S University Hospital
Leeds , LS9 7, United Kingdom
The Christie
Manchester , M20 4, United Kingdom
Churchill Hospital
Oxford , OX3 7, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

468

Study ID:

NCT06203210

Recruitment Status:

Not yet recruiting

Sponsor:


Daiichi Sankyo

How clear is this clinincal trial information?

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