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

Study acronym: IDeate-Lung02
StatusRecruiting
PhasePhase 3
Started2024-05-21
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 9 months later Apr 30, 2027 → Jan 30, 2028
Primary endpoint removed 2 → 1 primary endpoints
See other at-risk trials from Daiichi Sankyo

Amendment history

2026-08-04
Study Status, Contacts/Locations v24
Primary endpoint(s) modified2 to 1 entries
WasNumber of Participants With Objective Response Rate Assessed by Blinded Independent Central Review, Overall Survival
NowOverall Survival (OS)
Trial sites reduced: 232 → 229 locations
Primary completion pushed: 2027-04-30 → 2028-01-30
Completion pushed: 2029-02-22 → 2029-12-01
Study sitesdetails revised at 10 of 229 sites
2026-08-03
Study Identification, Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v23
Primary completion date2027-04-30→2028-01-30
Completion date2029-02-22→2029-12-01
Study sites232→229
Eligibility criteria+73 characters
[...] tion into the study: Sign and date the informed consent form (ICF) prior to the start of any study-specific qualification procedures. Adults greater than or equal to (≥)18 years or the minimum legal adult age (whichever is greater) at the time the informed consent formICF is signed. Has histologically or cytologically documented e [...] least 2 cycles of therapy and a chemotherapy free-interval [CTFI] (duration from stop date of the platinum agent in 1L therapy to radiological PD) of ≥30 days. Has at least 1 measurable lesion according to R [...] n or after the most recent systemic therapy. Has ECOG PS of [...]
Secondary endpoints12 to 14 entries
Number of Participants With Objective Response Rate Assessed by Investigator Progression-free Survival As(OR) Assessed by Blinded Independent Central Review (BICR) Per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1) Number of Participants With OR Assessed by Investigator Per RECIST v1.1 Progression-free Survival (PFS) as Assessed by BICR and Investigator Duration of Response As(DoR) as Assessed by Blinded Independent Central ReviewBICR and Investigator Disease Control Rate Asas Assessed by Blinded Independent Central ReviewBICR and Investigator Time to Response As(TTR) a [...] [...]
Primary endpoints2 to 1 entries
Number of Participants With Objective Response Rate Assessed by Blinded Independent Central Review Overall Survival (OS)
Study description-43 characters
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 p [...]
2026-05-29
Study Status, Contacts/Locations v22
Study sites230→232
2026-02-27
Study Status, Contacts/Locations v21
Study sites230 entries, revised
Hospital BeneficănciaBenefică Ncia Portuguesa de SăoSă O Paulo Centre Hospitalier Intercommunal de CrăteilCră Teil Assistance Publique-HăpitauxHă"Pitaux de Marseille Ch de Mulhouse - HăpitalHă"Pital Emile Muller Chu Nantes - HăpitalHă"Pital Guillaume Et Renă LaănnecLaă<Nnec HăpitalHă"Pital Foch Azienda Ospedaliera Universitaria- Universită Degli Studi Della Campania Âluigi Luigi Vanvitelliâ Centro Hospitalar E UniversitărioUniversită Rio de Coimbra E.P.E. Hospital Da Senhora Da Oliveira GuimarăesGuimară Es
2026-02-05
Active, Not Recruiting→Recruiting Study Status, Eligibility, Contacts/Locations v20
Trial statusActive, Not Recruiting→Recruiting
Eligibility criteria+385 characters
[...] lar disease. Has clinically significant corneal disease. Has any history of (non-infectious) interstitial lung disease (ILD)/pneumonitis thatirrespective requiredof corticosteroidssteroid use, or current ILD/pneumonitis, or suspected ILD/pneumonitis, or ILD that cannot be ruled out by imaging at Screening. Participants may be eligible if they had history of radiation pneumonitis that did not require steroids. Examples of suspected ILD/pneumonitis by imaging include the presence of lung parenchymal fibrosis, such as combined pulmonary fibrosis and emphysema (CPFE) and any radiographic features [...] [...]
Study sites230 entries, revised
Hospital Benefică NciaBeneficăncia Portuguesa de Să OSăo Paulo Centre Hospitalier Intercommunal de Cră TeilCrăteil Assistance Publique-Hă"PitauxHăpitaux de Marseille Ch de Mulhouse - Hă"PitalHăpital Emile Muller Chu Nantes - Hă"PitalHăpital Guillaume Et Renă Laă<NnecLaănnec Hă"PitalHăpital Foch Azienda Ospedaliera Universitaria- Universită Degli Studi Della Campania  LuigiÂluigi Vanvitelliâ Centro Hospitalar E Universită RioUniversitărio de Coimbra E.P.E. Hospital Da Senhora Da Oliveira Guimară EsGuimarăes
Show 19 earlier versions
2026-01-15
Study Status, Contacts/Locations v19
Study sites230 entries, revised
Rush UniversityMD MedicalAnderson Cancer Center UZAUniversitair Ziekenhuis Antwerpen
2025-12-01
Study Status, Contacts/Locations v18
Study sites230 entries, revised
Hospital BeneficănciaBenefică Ncia Portuguesa de SăoSă O Paulo Centre Hospitalier Intercommunal de CrăteilCră Teil Assistance Publique-HăpitauxHă"Pitaux de Marseille Ch de Mulhouse - HăpitalHă"Pital Emile Muller Chu Nantes - HăpitalHă"Pital Guillaume Et Renă LaănnecLaă<Nnec HăpitalHă"Pital Foch Azienda Ospedaliera Universitaria- Universită Degli Studi Della Campania Âluigi Luigi Vanvitelliâ Centro Hospitalar E UniversitărioUniversită Rio de Coimbra E.P.E. Hospital Da Senhora Da Oliveira GuimarăesGuimară Es
2025-10-24
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v17
Trial statusRecruiting→Active, Not Recruiting
Study sites230 entries, revised
Hospital Benefică NciaBeneficăncia Portuguesa de Să OSăo Paulo Centre Hospitalier Intercommunal de Cră TeilCrăteil Assistance Publique-Hă"PitauxHăpitaux de Marseille Ch de Mulhouse - Hă"PitalHăpital Emile Muller Chu Nantes - Hă"PitalHăpital Guillaume Et Renă Laă<NnecLaănnec Hă"PitalHăpital Foch Azienda Ospedaliera Universitaria- Universită Degli Studi Della Campania  LuigiÂluigi Vanvitelliâ Centro Hospitalar E Universită RioUniversitărio de Coimbra E.P.E. Hospital Da Senhora Da Oliveira Guimară EsGuimarăes
2025-09-15
Study Status, Contacts/Locations v16
Study sitesdetails revised at 15 of 230 sites
2025-08-06
Study Status, Contacts/Locations v15
Study sites230 entries, revised
UcsfUCSF MountMission ZionBay MedicalMission CtrHall Cleveland Clinic Mercy MedicalHospital Centre Center ChuHospitalier Universitaire de Liă GeLiege Institut Universitaire de Cardiologie Etet de Pneumologie de Quebec Fondazione IrccsIRCCS Istituto Nazionale Deidei Tumori IeoIEO Istituto Europeo Didi Oncologia Dr. Abdurrahman Yurtaslan Ankara Oncology TeachingTraining and Research Hospital Ankara Bilkent City Hospital Goztepe Prof. Dr. Suleyman Yalcin City Hospital
2025-06-02
Study Status, Contacts/Locations v14
Study sites230 entries, revised
University of Maryland MedicalGreenebaum GroupComprehensive Cancer Center Icesp -ICESP Instituto Dodo Câncer Dodo Estado de São Paulo Octavio Frias de Oliveira
2025-05-12
Study Status, Contacts/Locations v13
Study sites230 entries, revised
Clinical Research Providence Medical Foundation DavidUCLA GeffenHematology-Oncology AdventHealth SchoolOrlando, Cancer Institute University of Medicine Adventhealth Cancer Insitute Nebraska EducationalMedical Biomedical Research AssociationCenter Hospital Alemă OAlemão Oswaldo Cruz BacsBács-Kiskun VarmegyeiVármegyei OktatokorhazOktatókórház
2025-04-01
Study Status, Contacts/Locations v12
Study sites229→230
2025-03-03
Study Status, Contacts/Locations v11
Study sites229 entries, revised
TheTHE WEST CLINIC, PLLC dba West ClinicCancer Center UniversitaetsklinikumUNIVERSITATSKLINIKUM GiessenGIeBEN UndUND MarburgMARBURG Gmbh Standort GiessenGMBH
2025-02-13
Study Status, Contacts/Locations v10
Study sites229 entries, revised
New York University Cancer Center - Laura and Isaac Perlmutter Cancer Center At Nyu Langone Chris OâbrienOâ Brien Lifehouse Chu de LiăgeLiă Ge Hospital de CăncerCă'Ncer de Barretos - FundaăăoFundaă Ă O Pio Xii Cepon - Centro de Pesquisas OncolăgicasOncolă"Gicas de Santa Catarina Hospital BeneficănciaBenefică Ncia Portuguesa de SăoSă O Paulo Hospital AlemăoAlemă O Oswaldo Cruz The First Affiliated Hospital of XiâanXiân Jiaotong University Centre Hospitalier Intercommunal de CrăteilCră Teil HopitalInstitut AlbertCœur CalmettePoumon -CHU Chude Lille Assistance Publique-HăpitauxHă"Pitaux de Marsei [...] [...]
2024-12-03
Study Status, Contacts/Locations v9
Study sitesdetails revised at 34 of 229 sites
2024-11-26
Study Status, Contacts/Locations v8
Study sites230→229
2024-11-11
Study Identification, Study Status, Study Design, Outcome Measures, Eligibility, Contacts/Locations v7
Enrollment target468→540
Eligibility criteria-51 characters
[...] m is signed. Has histologically or cytologically documented extensive-stage small cell lung cancer (ES-SCLC). The participant must provide adequate baseline tumor sampl [...] or SCLC with at least 2 cycles of therapy and a chemotherapy free-free interval of >≥30 days. Has at least 1 measurable lesion according to RECIS [...] or after the most recent systemic therapy. Has ECOG PS of ≤1 within 7 days prior to Cycle 1 Day 1 (C1D1). Has no evidence of brain or leptomeningeal disease (spinal cord or central nervous system [CNS] metastases) based on history and physical examination. Subjects with untreated and as [...] [...]
Secondary endpointsdetails revised at 12 of 12 entries
Study sitesdetails revised at 24 of 230 sites
2024-10-02
Study Status, Contacts/Locations v6
Study sitesdetails revised at 230 of 230 sites
2024-09-09
Study Status, Contacts/Locations v5
Study sitesdetails revised at 5 of 230 sites
2024-08-02
Study Status, Contacts/Locations v4
Study sites229→230
2024-07-25
Study Status, Contacts/Locations v3
Study sites221→229
2024-06-25
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-06-10→confirmed 2024-05-21
Study sites199→221
2024-04-19
Study Identification, Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v1
Primary completion date2026-07-31→2027-04-30
Completion date2028-01-31→2029-02-22
Start date2024-03-31→2024-06-10
Study sites0→199
Eligibility criteria+247 characters
[...] ty of tumor tissue content. Has received prior therapy with at leastonly 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 one1 measurable lesion according to RECIST v1.1 as assessed by t [...] after the most recent systemic therapy. Has ECOG PS of ≤1. ParticipantsSubjects with untreated and asymptomatic brain metastases or subject [...] ith 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 [...] [...]
Secondary endpoints9 to 12 entries
Number of Participants With Objective Response Rate Assessed by Investigator Following I-DXd Monotherapy Progression-free Survival As Assessed by Blinded Independent Central Review and Investigator Following I-DXd Monotherapy Duration of Response As Assessed by Blinded Independent Central Review and Investigator Following I-DXd Monotherapy Disease Control Rate As Assessed by Blinded Independent Central Review and Investigator Following I-DXd Monotherapy Time to Response As Assessed by Blinded Independent Central Review and Investigator Pharmacokinetic FollowingParameter Maximum Concentration f [...] [...]
Primary endpoints2 entries, revised
Number of Participants With Objective Response Rate Assessed by Blinded Independent Central Review Following I-DXd Monotherapy Overall Survival Following I-DXd Monotherapy
Study description+44 characters
[...] luding patient reported outcomes), immunogenicity of I-DXd, and B7-H3 protein expression, and characterize the pharmacokinetics of I-DXd.
2024-01-02
Original filing
This study is 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).
Trial Details
NCT Number NCT06203210
Lead Sponsor Daiichi Sankyo
Collaborators: Merck Sharp & Dohme LLC
Conditions Small Cell Lung Cancer
Enrollment 540 participants
Start Date 2024-05-21
Primary Completion 2028-01-30 (estimated)
Study Completion 2029-12-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-06