A Study of Ifinatamab Deruxtecan Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer
Launched by DAIICHI SANKYO · Jan 2, 2024
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is comparing a new treatment called Ifinatamab Deruxtecan (I-DXd) with the standard treatment chosen by doctors for patients with relapsed small cell lung cancer (SCLC). The goal is to see which treatment works better and is safer for people whose cancer has returned after previous therapy. The study is currently looking for participants aged 18 and older who have been diagnosed with SCLC and have received a specific type of chemotherapy before.
To be eligible, participants must have measurable cancer lesions and must have shown that their disease has progressed after their last treatment. They should also be in fairly good health, with a performance status that allows them to carry out daily activities. If you participate, you will receive either the new treatment or the doctor's choice of treatment, and you’ll be monitored closely for any side effects or changes in your condition. This trial is an important opportunity to help find potentially better treatment options for people facing this challenging type of cancer.
Gender
ALL
Eligibility criteria
- • 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 extensive-stage small cell lung cancer (ES-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 within 7 days prior to Cycle 1 Day 1 (C1D1).
- • 9. Has no evidence of brain or leptomeningeal disease (spinal cord or central nervous system \[CNS\] metastases) based on history and physical examination. Subjects must require no treatment with steroids or anticonvulsants and 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 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.
About Daiichi Sankyo
Daiichi Sankyo is a global healthcare company headquartered in Tokyo, Japan, dedicated to the research, development, and commercialization of innovative pharmaceuticals and vaccines. With a strong focus on oncology, cardiovascular diseases, and rare disorders, Daiichi Sankyo leverages advanced technologies and a robust pipeline to address unmet medical needs worldwide. Committed to fostering collaboration and scientific excellence, the company engages in clinical trials that aim to bring transformative therapies to patients while adhering to the highest standards of safety and efficacy. Through its comprehensive approach to drug development, Daiichi Sankyo strives to improve patient outcomes and enhance the quality of life for individuals around the globe.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Milwaukee, Wisconsin, United States
Brussels, , Belgium
Edmonton, , Canada
Madrid, , Spain
Chicago, Illinois, United States
Madrid, , Spain
Portland, Oregon, United States
Canton, Ohio, United States
Boston, Massachusetts, United States
Detroit, Michigan, United States
Barcelona, , Spain
Oxford, , United Kingdom
Lebanon, New Hampshire, United States
Houston, Texas, United States
Rozzano, , Italy
Villejuif Cedex, , France
Villejuif, , France
Lexington, Kentucky, United States
Birmingham, , United Kingdom
Fukuoka, , Japan
Okayama, , Japan
Erfurt, , Germany
Lyon, , France
Beijing, , China
Cordoba, , Spain
Madrid, , Spain
Taichung, , Taiwan
Bruxelles, , Belgium
Amsterdam, , Netherlands
Paris, , France
Milano, , Italy
St. Gallen, , Switzerland
Ballarat, Victoria, Australia
Sevilla, , Spain
Sevilla, , Spain
Lodz, , Poland
Minden, , Germany
Sevilla, , Spain
Praha 4, , Czechia
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Hamburg, , Germany
Otwock, , Poland
Madrid, , Spain
Woolloongabba, , Australia
Seoul, , Korea, Republic Of
Krakow, , Poland
Beijing, , China
Shanghai, , China
Seongnam Si, , Korea, Republic Of
Seoul, , Korea, Republic Of
Hangzhou, , China
Barcelona, , Spain
Budapest, , Hungary
Feldkirch, , Austria
Ulm, , Germany
Chengdu, Sichuan, China
Harbin, , China
Baltimore, Maryland, United States
Budapest, , Hungary
Taipei, , Taiwan
Oldenburg, , Germany
Leeds, , United Kingdom
Berlin, , Germany
Milano, , Italy
Kashiwa, , Japan
Edegem, , Belgium
Maastricht, , Netherlands
Tyler, Texas, United States
Shanghai, Shanghai, China
Las Palmas De Gran Canaria, , Spain
'S Hertogenbosch, , Netherlands
Taoyuan County, , Taiwan
Wakayama, , Japan
Lisboa, , Portugal
Barcelona, , Spain
Springdale, Arkansas, United States
Jinan, , China
Zhengzhou, , China
Roeselare, , Belgium
Wuhan, , China
Gauting, , Germany
Milano, , Italy
Los Angeles, California, United States
Malaga, , Spain
Madrid, , Spain
Parma, , Italy
Suwon, , Korea, Republic Of
Hangzhou, , China
Chuo Ku, , Japan
Germantown, Tennessee, United States
Shenyang, , China
Montpellier, , France
Houston, Texas, United States
Daegu, , Korea, Republic Of
Liberec, , Czechia
Manchester, , United Kingdom
Bronx, New York, United States
Avignon Cedex 9, , France
Bergamo, , Italy
Piraeus, , Greece
Athens, , Greece
Olomouc, , Czechia
Rennes Cedex 09, , France
Tampa, Florida, United States
Roma, , Italy
Bern, , Switzerland
Porto Alegre, , Brazil
Beijing, , China
Istanbul, , Turkey
Ballarat, , Australia
Suwon Si, , Korea, Republic Of
Lake Success, New York, United States
Seoul, , Korea, Republic Of
Monza, , Italy
Tilburg, , Netherlands
Istanbul, , Turkey
San Francisco, California, United States
Budapest, , Hungary
Lisboa, , Portugal
Porto, , Portugal
Comuna Floresti, , Romania
Neptune, New Jersey, United States
Changsha, , China
Chengdu, , China
Chongqing, , China
Krems, , Austria
St Albans, , Australia
Diyarbakir, , Turkey
Larisa, , Greece
Tianjin, , China
Yvoir, , Belgium
Sunto Gun, , Japan
Bydgoszcz, , Poland
Genova, , Italy
Cheongju, , Korea, Republic Of
Baltimore, Maryland, United States
Linz, , Austria
Perugia, , Italy
Bari, , Italy
Kiel, , Germany
Kaohsiung City, , Taiwan
East Brunswick, New Jersey, United States
Osaka Sayama, , Japan
Sagamihara, , Japan
Sapporo, , Japan
Subiaco, , Australia
Frankfurt, , Germany
Hasselt, , Belgium
Hirakata Shi, , Japan
Tokyo, , Japan
Ankara, , Turkey
Ankara, , Turkey
Fullerton, California, United States
Catanzaro, , Italy
Brampton, , Canada
Takatsuki, , Japan
Toronto, , Canada
Wien, , Austria
L'hospitalet De Llobregat, , Spain
Linyi, , China
Urumqi, , China
Izmir, , Turkey
Gera, , Germany
São Paulo, , Brazil
Baltimore, Maryland, United States
Yantai, , China
Camperdown, , Australia
Los Angeles, California, United States
Koto Ku, , Japan
Matsuyama, , Japan
Halifax, , Canada
Istanbul, , Turkey
Taipei, , Taiwan
Zhengzhou, , China
Jaen, , Spain
Wuhan, , China
Taichung, , Taiwan
Germantown, Tennessee, United States
Rennes Cedex 09, , France
Haerbin, , China
Xiangyang, , China
Wuhan, , China
Santo Andre, , Brazil
Verona, , Italy
Perugia, , Italy
Sao Jose Rio Preto, , Brazil
Ankara, , Turkey
Santo Andre, , Brazil
Kecskemet, , Hungary
Kecskemet, , Hungary
Changsha, , China
Tapei, , Taiwan
Gyor, , Hungary
Durham, North Carolina, United States
Montpellier Cedex 05, , France
Paris Cedex 05, , France
Goyan Si, , Korea, Republic Of
Bedford Park, , Australia
Miami, Florida, United States
Orlando, Florida, United States
Boston, Massachusetts, United States
Saint Louis, Missouri, United States
Omaha, Nebraska, United States
Mineola, New York, United States
Camperdown, , Australia
Townsville, , Australia
Liege, , Belgium
Barretos, , Brazil
Florianăłpolis, , Brazil
Itajaă , , Brazil
Săło Paulo, , Brazil
Săło Paulo, , Brazil
Săło Paulo, , Brazil
Săło Paulo, , Brazil
Changchun, , China
Neijiang, , China
Wuhan, , China
Xi'an, , China
Bordeaux Cedex, , France
Creteil Cedex, , France
Lille Cedex, , France
Limoges Cedex, , France
Marseille, , France
Mulhouse Cedex, , France
Saint Herblain, , France
Saint Priest En Jarez, , France
Suresnes Cedex, , France
Essen, , Germany
Frankfurt Am Main, , Germany
Giessen, , Germany
Immenhausen/Krs. Kassel, , Germany
Brescia, , Italy
Catania, , Italy
Napoli, , Italy
Roma, , Italy
Prabuty, , Poland
Tomaszow Mazowiecki, , Poland
Coimbra, , Portugal
Guimarães, , Portugal
Cluj Napoca, , Romania
Craiova, , Romania
Suceava, , Romania
Jerez De Frontera, , Spain
Măąlaga, , Spain
Fribourg, , Switzerland
Tainan, , Taiwan
Taipei, , Taiwan
Chengdu Shi, , China
Athens, , Greece
Athens, , Greece
Cincinnati, Ohio, United States
Camperdown, , Australia
Wien, , Austria
Liege, , Belgium
Barretos, , Brazil
Florianăłpolis, , Brazil
Porto Alegre, , Brazil
Săło Paulo, , Brazil
Săło Paulo, , Brazil
Quebec City, , Canada
Winnipeg, , Canada
Jiangxi, , China
Liaoning, , China
Wuhan Shi, , China
Xi'an, , China
Creteil Cedex, , France
Marseille, , France
Mulhouse Cedex, , France
Saint Herblain, , France
Suresnes Cedex, , France
Chaidari, , Greece
Patra, , Greece
Thessaloniki, , Greece
Napoli, , Italy
Coimbra, , Portugal
Guimarães, , Portugal
New York, New York, United States
Săło Paulo, , Brazil
Shandong, , China
Xi'an, , China
Lille, , France
S Hertogenbosch, , Netherlands
Coimbra, , Portugal
Giessen, , Germany
Barretos, , Brazil
Itajaă , , Brazil
Essen, , Germany
Catanzaro, , Italy
Villars Sur Glâne, , Switzerland
Fullerton, California, United States
Orlando, Florida, United States
Omaha, Nebraska, United States
São Paulo, , Brazil
São Paulo, , Brazil
Patients applied
Trial Officials
Global Clinical Director
Study Director
Daiichi Sankyo
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported