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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06203210
Other study ID # DS7300-188
Secondary ID 2023-509628-16
Status Not yet recruiting
Phase Phase 3
First received
Last updated
Start date June 10, 2024
Est. completion date February 22, 2029

Study information

Verified date April 2024
Source Daiichi Sankyo
Contact Daiichi Sankyo Contact for Clinical Trial Information
Phone 9089926400
Email CTRinfo@dsi.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 468
Est. completion date February 22, 2029
Est. primary completion date April 30, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria Participants must meet all the following criteria to be eligible for randomization into the study: 1. Sign and date the informed consent form prior to the start of any study-specific qualification procedures. 2. Adults =18 years or the minimum legal adult age (whichever is greater) at the time the informed consent form is signed. 3. Has histologically or cytologically documented SCLC. 4. The participant must provide adequate baseline tumor samples with sufficient quantity and quality of tumor tissue content. 5. 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. 6. Has at least 1 measurable lesion according to RECIST v1.1 as assessed by the investigator. 7. Has documentation of radiological disease progression on or after the most recent systemic therapy. 8. Has ECOG PS of =1. 9. 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: 1. Has received prior treatment with orlotamab, enoblituzumab, or other humanized anti-B7 homologue 3 (B7-H3) targeted agents, including I-DXd. 2. Prior discontinuation of an antibody drug conjugate (ADC) that consists of an exatecan derivative (eg, trastuzumab deruxtecan) due to treatment-related toxicities. 3. Has received any of the comparators used in this study or any topoisomerase I inhibitor. 4. Has inadequate washout period before randomization as specified in the protocol. 5. Has any of the following conditions within the past 6 months: cerebrovascular accident, transient ischemic attack, or another arterial thromboembolic event. 6. Has uncontrolled or significant cardiovascular disease. 7. Has clinically significant corneal disease. 8. 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. 9. 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 Design


Intervention

Drug:
Ifinatamab deruxtecan
12 mg/kg intravenous dose on Day 1 of each 21-day cycle
Topotecan
Topotecan will be administered per local SoC.
Amrubicin
Amrubicin will be administered per local SoC.
Lurbinectedin
Lurbinectedin will be administered per local SoC

Locations

Country Name City State
Australia Ballarat Base Hospital Ballarat
Australia Chris Oâ Brien Lifehouse Camperdown
Australia Sunshine Hospital St Albans
Australia St John of God Subiaco Hospital Subiaco
Australia Townsville Cancer Centre Townsville
Australia Princess Alexandra Hospital Woolloongabba
Belgium Cliniques Universitaires Saint-Luc Brussels
Belgium UZA Edegem
Belgium Jessa Ziekenhuis Hospital Hasselt
Belgium Chu de Lia Ge Liege
Belgium AZ DELTA Roeselare
Belgium Chu Ucl Namur Yvoir
Brazil Hospital de Ca'Ncer de Barretos - Fundaa A O Pio Xii Barretos
Brazil Cepon - Centro de Pesquisas Oncola"Gicas de Santa Catarina FlorianAlpolis
Brazil Clínica de Neoplasias Litoral Ltda. ItajaA-
Brazil Hospital São Lucas Da Pucrs Porto Alegre
Brazil A. C. Camargo Cancer Center SALo Paulo
Brazil Hospital Benefica Ncia Portuguesa de Sa O Paulo SALo Paulo
Brazil Hospital Sirio-Libanes SALo Paulo
Brazil Icesp - Instituto Do Câncer Do Estado de São Paulo Octavio Frias de Oliveira SALo Paulo
Brazil Cepho - Centro de Estudos E Pesquisas de Hematologia E Oncologia Santo Andre
Brazil Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Sao Jose Rio Preto
Canada Queen Elizabeth Ii Health Sciences Centre Halifax
Canada Princess Margaret Cancer Center Toronto
China Beijing Cancer Hospital Beijing
China Beijing Chest Hospital,Capital Medical University Beijing
China Jilin Province Tumor Hospital Changchun
China Hunan Cancer Hospital Changsha
China Sichuan Cancer Hospital Chengdu
China West China Hospital, Sichuan University Chengdu
China Chongqing University Cancer Hospital Chongqing
China The First Affiliated Hospital, College of Medicine, Zhejiang University Hangzhou
China Zhejiang Cancer Hospital Hangzhou
China Harbin Medical University Cancer Hospital Harbin
China Shandong Cancer Hospital Jinan
China Linyi Cancer Hospital Linyi
China The Second Peoples Hospital of Neijiang Neijiang
China Fudan University Shanghai Cancer Center Shanghai
China Tianjin Medical University Cancer Institute & Hospital Tianjin
China The Affiliated Cancer Hospital of Xinjiang Medical University Urumqi
China Hubei Cancer Hospital Wuhan
China Union Hospital of Tongji Medical College, Huazhong University of Science and Technology Wuhan
China The First Affiliated Hospital of Xiâ An Jiaotong University Xi'an
China Xiangyang Central Hospital Xiangyang
China Yantai Yuhuangding Hospital Yantai
China Henan Cancer Hospital Zhengzhou
France Institut Sainte Catherine Avignon Cedex 9
France Chu Bordeaux Bordeaux cedex
France Centre Hospitalier Intercommunal de Cra Teil Creteil Cedex
France Hopital Albert Calmette - Chu Lille Lille Cedex
France Chu Limoges - Hopital Du Cluzeau Limoges cedex
France Centre Léon Bérard Lyon
France Assistance Publique-Ha"Pitaux de Marseille Marseille
France Institut Régional Du Cancer de Montpellier Montpellier
France Hopital Arnaud de Villeneuve Montpellier cedex 05
France Ch de Mulhouse - Ha"Pital Emile Muller Mulhouse Cedex
France Hopital Tenon Paris
France Institut Curie - Site de Paris Paris Cedex 05
France Chu Rennes - Hopital Pontchaillou Rennes cedex 09
France Chu Nantes - Ha"Pital Guillaume Et Rena Laa<Nnec Saint Herblain
France Institut de Cancerologie de La Loire Saint-Priest-En-Jarez
France Ha"Pital Foch Suresnes Cedex
France Institut Gustave Roussy Villejuif cedex
Germany Evangelische Lungenklinik Berlin Berlin
Germany Helios Klinikum Erfurt Erfurt
Germany Universtitaetsklinikum Essen Essen
Germany Krankenhaus Nordwest Gmbh Frankfurt
Germany Universitaetsklinikum Frankfurt Goethe-Universitaet Frankfurt am Main
Germany Asklepios Fachkliniken Muenchen-Gauting Gauting
Germany Srh Wald-Klinikum Gera Gmbh Gera
Germany Universitaetsklinikum Giessen Und Marburg Gmbh Standort Giessen Giessen
Germany Asklepios Klinik Harburg Hamburg
Germany Lki Lungenfachklinik Immenhausen Immenhausen/Krs. Kassel
Germany Staedtisches Krankenhaus Kiel Kiel
Germany Johannes Wesling Klinikum Minden Minden
Germany Pius-Hospital Oldenburg Oldenburg
Germany Universitaetsklinikum Ulm Ulm
Hungary Orszagos Koranyi Pulmonologiai Intezet Budapest
Hungary Orszagos Onkologiai Intezet Budapest
Hungary Semmelweis Egyetem Budapest
Hungary Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz Gyor
Hungary Bacs-Kiskun Varmegyei Oktatokorhaz Kecskemet
Italy Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari Bari
Italy Humanitas Gavazzeni Bergamo
Italy Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia (Presidio Spedali Civili) Brescia
Italy Azienda Ospedaliera Universitaria Policlinico - Vittorio Emanuele (Presidio Gaspare Rodolico) Catania
Italy Azienda Ospedaliero Universitaria Mater Domini Catanzaro
Italy Istituto Nazionale Per La Ricerca Sul Cancro Di Genova Genova
Italy Fondazione Irccs Istituto Nazionale Dei Tumori Milano
Italy Ieo Istituto Europeo Di Oncologia Milano
Italy Ospedale San Raffaele Milano
Italy Azienda Socio Sanitaria Territoriale Di Monza (Presidio San Gerardo) Monza
Italy Azienda Ospedaliera Universitaria- Universita Degli Studi Della Campania  Luigi Vanvitelliâ Napoli
Italy Azienda Ospedaliero Universitaria Di Parma Parma
Italy Azienda Ospedaliera Di Perugia Ospedale S. Maria Della Misericordia Perugia
Italy Istituto Nazionale Tumori Regina Elena Irccs Roma
Italy Istituto Clinico Humanitas Rozzano
Italy Centro Ricerche Cliniche Di Verona S.R.L. Verona
Japan National Cancer Center Hospital Chuo-ku
Japan Kyushu University Hospital Fukuoka
Japan National Cancer Center Hospital East Kashiwa
Japan The Cancer Institute Hospital of Jfcr Koto-ku
Japan National Hospital Organization Shikoku Cancer Center Matsuyama
Japan Okayama University Hospital Okayama
Japan Kindai University Hospital Osaka-Sayama
Japan Kitasato University Hospital Sagamihara
Japan National Hospital Organization Hokkaido Cancer Center Sapporo
Japan Shizuoka Cancer Center Sunto-gun
Japan Osaka Medical and Pharmaceutical University Hospital Takatsuki
Japan Wakayama Medical University Hospital Wakayama
Korea, Republic of Chungbuk National University Hospital Cheongju
Korea, Republic of Kyungpook National University Chilgok Hospital Daegu
Korea, Republic of National Cancer Center Goyan-si
Korea, Republic of Seoul National University Bundang Hospital Seongnam-si
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Samsung Medical Center Seoul
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of Severance Hospital, Yonsei University Health System Seoul
Korea, Republic of The Catholic University of Korea, St. Vincent'S Hospital Suwon-si
Netherlands Jeroen Bosch Ziekenhuis 's Hertogenbosch
Netherlands Netherlands Cancer Institute Amsterdam
Netherlands Maastricht University Medical Center Maastricht
Netherlands Etz Elisabeth Tilburg
Poland Krakowski Szpital Specjalistyczny Im. Jana Pawla Ii Krakow
Poland Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy Otwock
Poland Szpital Specjalistyczny W Prabutach Prabuty
Poland Provita Prolife Tomaszow Mazowiecki
Portugal Centro Hospitalar E Universita Rio de Coimbra E.P.E. Coimbra
Portugal Hospital Da Senhora Da Oliveira Guimara Es Guimarães
Portugal Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital Pulido Valente Lisboa
Portugal Hospital Da Luz Lisboa
Romania Institutul Oncologic 'Prof. Dr. Ion Chiricuta' Cluj Napoca Cluj Napoca
Romania S.C Radiotherapy Center Cluj S.R.L Comuna Floresti
Romania S.C Centrul de Oncologie Sfantul Nectarie Craiova Craiova
Romania S.C. Sigmedical Services Srl Suceava
Spain Hospital Clinic de Barcelona Barcelona
Spain Hospital de La Santa Creu I Sant Pau Barcelona
Spain Hospital Universitari Vall D'Hebron Barcelona
Spain Hospital Universitario Reina Sofia Cordoba
Spain Hospital Universitario Ciudad de Jaen Jaen
Spain Hospital de Especialidades de Jerez de La Frontera Jerez De Frontera
Spain Ico L'Hospitalet - Hospital Duran I Reynals L'Hospitalet de Llobregat
Spain Complejo Hospitalario Universitario Insular Materno-Infantil Las Palmas de Gran Canaria
Spain Hospital Regional Universitario de Malaga MAAlaga
Spain Hospital General Universitario Gregorio Marañon Madrid
Spain Hospital Universitario Fundacion Jimenez Diaz Madrid
Spain Hospital Universitario Ramon Y Cajal Madrid
Spain Hospital Universitario Virgen Del Rocio Sevilla
Spain Hospital Universitario Virgen Macarena Sevilla
Switzerland Inselspital - Universitaetsspital Bern Bern
Switzerland Hfr Fribourg/Kantonsspital Fribourg Fribourg
Switzerland Kantonsspital St. Gallen St. Gallen
Taiwan Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung City
Taiwan China Medical University Hospital Taichung
Taiwan Taichung Veterans General Hospital Taichung
Taiwan National Cheng Kung University Hospitalx Tainan
Taiwan National Taiwan University Cancer Centre Taipei
Taiwan Taipei Medical University Hospital Taipei
Taiwan Chang Gung Memorial Hospital Taoyuan County
Taiwan Taipei Veterans General Hospital Tapei
Turkey Ankara City Hospital Ankara
Turkey Dr. Abdurrahman Yurtaslan Oncology Teaching and Research Hospital Ankara
Turkey Dicle University, Medical Faculty Diyarbakir
Turkey Goztepe Prof. Dr. Suleyman Yalcin City Hospital Istanbul
Turkey Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty Istanbul
Turkey Medipol University Medical Faculty Istanbul
Turkey Izmir Medicalpark Hospital Izmir
United Kingdom Birmingham Heartlands Hospital Birmingham
United Kingdom St James'S University Hospital Leeds
United Kingdom The Christie Manchester
United Kingdom Churchill Hospital Oxford
United States John Hopkins School of Medicine Baltimore Maryland
United States University of Maryland Medical Group Baltimore Maryland
United States Dana-Farber Cancer Institute Boston Massachusetts
United States Montefiore Medical Center Prime Bronx New York
United States Mercy Medical Center Canton Ohio
United States Rush University Medical Center Chicago Illinois
United States Henry Ford Health System Detroit Michigan
United States Duke University Health System Durham North Carolina
United States Astera Cancer Care East Brunswick New Jersey
United States Providence Medical Foundation Fullerton California
United States The West Clinic Germantown Tennessee
United States Houston Methodist Cancer Center Houston Texas
United States University of Texas Md Anderson Cancer Center Houston Texas
United States Clinical Research Alliance, Inc Lake Success New York
United States Dartmouth-Hitchcock Medical Center Lebanon New Hampshire
United States Baptist Health Lexington Lexington Kentucky
United States David Geffen School of Medicine Los Angeles California
United States University of Miami Hospital and Clinics Sylvester Comprehensive Cancer Center Miami Florida
United States Medical College of Wisconsin Milwaukee Wisconsin
United States New York University Cancer Center - Laura and Isaac Perlmutter Cancer Center At Nyu Langone Mineola New York
United States Meridian Health Systems Neptune New Jersey
United States Nebraska Educational Biomedical Research Association Omaha Nebraska
United States Adventhealth Cancer Insitute Orlando Florida
United States Providence Portland Medical Center Portland Oregon
United States Mercy Clinic Oncology and Hematology Sindelar Cancer Center Saint Louis Missouri
United States Highlands Oncology Group Springdale Arkansas
United States H. Lee Moffitt Cancer Center and Research Institute, Inc Tampa Florida
United States Texas Oncology, P.A. - Tyler Tyler Texas

Sponsors (2)

Lead Sponsor Collaborator
Daiichi Sankyo Merck Sharp & Dohme LLC

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Brazil,  Canada,  China,  France,  Germany,  Hungary,  Italy,  Japan,  Korea, Republic of,  Netherlands,  Poland,  Portugal,  Romania,  Spain,  Switzerland,  Taiwan,  Turkey,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With Objective Response Rate Assessed by Blinded Independent Central Review Confirmed objective response rate (ORR) is defined as the sum of the complete response (CR) rate and partial response (PR) rate based on BICR by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 4.5 years
Primary Overall Survival From the date of randomization to the date of death due to any cause, whichever occurs first, up to approximately 4.5 years
Secondary Number of Participants With Objective Response Rate Assessed by Investigator Confirmed objective response rate (ORR) is defined as the sum of the complete response (CR) rate and partial response (PR) rate based on investigator by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 4.5 years
Secondary Progression-free Survival As Assessed by Blinded Independent Central Review and Investigator PFS is defined as the time interval from the date of randomization to the date of disease progression as per BICR and investigator assessment or death due to any cause. Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 4.5 years
Secondary Duration of Response As Assessed by Blinded Independent Central Review and Investigator Duration of response (DoR) is defined as the time from the date of the first documentation of objective response (complete response [CR] or partial response [PR]) to the date of the first documentation of progressive disease (PD) or death. The DoR will be calculated for responding participants (PR or CR) only. From the date of first documentation of confirmed response (CR or PR) to the first documentation of objective progression or to death due to any cause, whichever occurs first, up to approximately 4.5 years
Secondary Disease Control Rate As Assessed by Blinded Independent Central Review and Investigator Disease control rate is defined as the proportion of participants who have achieved a best overall response of confirmed CR, confirmed PR, or SD (or non-CR/non-PD) by BICR and investigator assessment per RECIST v1.1. Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 4.5 years
Secondary Time to Response As Assessed by Blinded Independent Central Review and Investigator TTR is defined as the time from the date of randomization to the first documentation of objective tumor response (CR or PR) that is subsequently confirmed by BICR and investigator assessment .Time to response (TTR) will be calculated for confirmed responders only. From the start date of study drug to the date of the first documentation of response (CR or PR) that is subsequently confirmed, up to approximately 4.5 years
Secondary Change from Baseline in The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30 This 30-item questionnaire assesses global health status (GHS)/quality of life (QoL), subject functioning, and general cancer symptoms and has a recall period of one week. All scores for the EORTC QLQ-C30 instrument are linearly transformed to a 0 to 100 metric, where a higher score on GHS/QoL and functioning scales indicates a better outcome and a higher score for the symptom scales indicates worse outcomes. Baseline up to 4.5 years
Secondary Change from Baseline in The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 29 (EORTC QLQ-LC29) The LC29 is a self-reported 29-item questionnaire that measures SCLC-related symptoms and the side effects of treatments and has a recall period of one week. All scores range from 0 to 100, with a higher score indicating a worse outcome. Baseline up to 4.5 years
Secondary Overall Number of Participants With Treatment-emergent Adverse Events Following I-DXd Monotherapy TEAEs are assessed based on NCI CTCAE v5.0. Baseline up to 4.5 years
Secondary The Number of Participants Who Are Anti-Drug Antibody (ADA)-Positive At Any Time and Who Have A Treatment-emergent Anti-Drug Antibody The ADA prevalence, which is the percentage of participants who are ADA positive at any time point (baseline or post-baseline), as well as the ADA incidence, which is the proportion of participants having treatment-emergent ADA during the study period, will only be reported in participants receiving I-DXd. Baseline up to 4.5 years
Secondary Pharmacokinetic Parameter Maximum Concentration for I-DXd, Total Anti-B7-H3 Antibody, and MAAA-1181a Maximum concentration (Cmax) will be assessed using non-compartmental methods in participants randomized to the I-DXd group. Cycle 1 before infusion (BI), end of infusion EOI), and 3, 6, 24, 72, 168, 336, and 504 hours (hrs) post dose; Cycle 2 BI and EOI; Cycle 3 BI, EOI, and 6 hrs postdose; Cycles 4, 5, and every 2 cycles thereafter up to 4.5 years BI (each cycle is 21 days)
Secondary Pharmacokinetic Parameter Time to Maximum Concentration for I-DXd, Total Anti-B7-H3 Antibody, and MAAA-1181a Time to maximum concentration (Tmax) will be assessed using non-compartmental methods in participants randomized to the I-DXd group. Cycle 1 before infusion (BI), end of infusion EOI), and 3, 6, 24, 72, 168, 336, and 504 hours (hrs) post dose; Cycle 2 BI and EOI; Cycle 3 BI, EOI, and 6 hrs postdose; Cycles 4, 5, and every 2 cycles thereafter up to 4.5 years BI (each cycle is 21 days)
Secondary Pharmacokinetic Parameter Area Under the Plasma Concentration-Time Curve for I-DXd, Total Anti-B7-H3 Antibody, and MAAA-1181a Area under the plasma concentration-time curve up to the last quantifiable time point (AUClast) and area under the plasma concentration-time curve dosing interval (AUCtau) will be assessed using non-compartmental methods in participants randomized to the I-DXd group. Cycle 1 before infusion (BI), end of infusion EOI), and 3, 6, 24, 72, 168, 336, and 504 hours (hrs) post dose; Cycle 2 BI and EOI; Cycle 3 BI, EOI, and 6 hrs postdose; Cycles 4, 5, and every 2 cycles thereafter up to 4.5 years BI (each cycle is 21 days)
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