Extensive-stage Small-cell Lung CancerPhase 2IDeate-Lung01NCT05280470
Ifinatamab Deruxtecan (I-DXd) in Subjects With Pretreated Extensive-Stage Small Cell Lung Cancer (ES-SCLC)
A Phase 2 study testing Ifinatamab Deruxtecan (I-DXd) in people with Extensive-stage Small-cell Lung Cancer, run by Daiichi Sankyo at 58 sites in 8 countries.
Trial summary
This 2-part study intends to define the recommended Phase 2 dose of ifinatamab deruxtecan (I-DXd) based on the efficacy, safety, and pharmacokinetics (PK) results observed in participants with Extensive-stage Small Cell Lung Cancer (ES-SCLC) who received at least 1 prior line of platinum-based chemotherapy and a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extensive-stage Small-cell Lung Cancer
- What is being tested?
- Ifinatamab Deruxtecan (I-DXd)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 187 participants
- Where
- 58 sitesin 8 countries
- Study dates
- 9 Mar 2022to 15 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must meet all the following criteria to be eligible for enrollment into the study:
- Sign and date the informed consent form (ICF) prior to the start of any study-specific qualification procedures.
- Participant must have at least one lesion, not previously irradiated, amenable to core biopsy.
- Male or female subjects aged ≥18 years (follow local regulatory requirements if the legal age of consent for study participation is >18 years old).
- Histologically or cytologically documented ES-SCLC.
- At least one measurable lesion according to RECIST v1.1 as assessed by the investigator.
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- Prior therapy with at least one platinum-based line as systemic therapy for extensive-stage disease with at least two cycles of therapy (except in the case of early objective PD) and beginning with protocol version 3.0, a minimum of two previous lines of systemic therapy.
- Documentation of radiological disease progression on or after most recent systemic therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
Who cannot join
- Participants who meet any of the following criteria will be disqualified from entering the study:
- Prior treatment with orlotamab, enoblituzumab, or other 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.
- Clinically active brain metastases, spinal cord compression or leptomeningeal carcinomatosis, defined as untreated or symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms.
- Any of the following conditions within the past 6 months: cerebrovascular accident, transient ischemic attack, or another arterial thromboembolic event.
- Clinically significant corneal disease.
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- Uncontrolled or significant cardiovascular disease.
- 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.
- Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses,
- Chronic steroid treatment (dose of 10 mg daily or more prednisone equivalent), except for low-dose inhaled steroids (for asthma/COPD) or topical steroids (for mild skin conditions) or intra-articular steroid injections.
- History of malignancy other than SCLC within the 3 years prior to enrollment, except adequately resected non-melanoma skin cancer, curatively treated in situ disease, superficial gastrointestinal (GI) tract tumors and non-muscle invasive bladder cancer curatively resected by endoscopic surgery.
- History of allogeneic bone marrow, stem cell, or solid organ transplant.
- Unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to National Cancer Institute- Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE V5.0), Grade ≤1 or baseline.
- History of hypersensitivity to the drug substances, inactive ingredients in the drug product or severe hypersensitivity reactions to other monoclonal antibodies.
- Evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection.
- Has active or uncontrolled hepatitis B or C infection.
- Active, known, or suspected autoimmune disease.
- Any evidence of severe or uncontrolled systemic diseases (including active bleeding diatheses, psychiatric illness/social situations, substance abuse).
- Has received a live vaccine within 30 days prior to the first dose of study drug.
- Female who is pregnant or breast-feeding or intends to become pregnant during the study.
- Prior or ongoing clinically relevant illness, medical condition, surgical history, physical finding, or laboratory abnormality that, in the investigator's opinion, could affect the safety of the participant.
- Known human immunodeficiency virus (HIV) infection that is not well controlled.
Trial locations and contacts
58 sites in 8 countries.
58 sites in 8 countries
United States16 sites
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21287
Dana-Faeber Cancer Institute
Boston, Massachusetts, 02215
University of Chicago Medical Center
Chicago, Illinois, 60637
Henry Ford Hospital
Detroit, Michigan, 48202
Duke University Health System
Durham, North Carolina, 27703
Cancer and Hematology Centers of Western Michigan
Grand Rapids, Michigan, 49503
Millennium Physicians Association, Llp
Houston, Texas, 77090
The Cancer Specialists, Llc
Jacksonville, Florida, 32256
Hackensack Meridian Health-Southern Ocean Medical Center
Manahawkin, New Jersey, 08050
Sarah Cannon (Tennessee Oncology - Nashville)
Nashville, Tennessee, 37203
Memorial Sloan-Kettering Cancer Center (Mskcc) - New York
New York, New York, 10065
University of Washington Medical Center
Seattle, Washington, 98195
Highlands Oncology Group
Springdale, Arkansas, 72762
Washington University School of Medicine
St Louis, Missouri, 63110
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
Montefiore Medical Center Prime
The Bronx, New York, 10461
China8 sites
Jilin Cancer Hospital
Changchun, 130012
Hunan Cancer Hospital
Changsha, 410013
West China Hospital, Sichuan University
Chengdu, 610041
Guangdong Provincial People'S Hospital
Guangdong, 510000
Zhejiang Cancer Hospital
Hangzhou, 310022
Linyi Cancer Hospital
Linyi, 276000
Fudan University Shanghai Cancer Center
Shanghai, 200032
Union Hospital of Tongji Medical College Huazhong University of Science and Technology
Wuhan, 430022
France7 sites
Centre Hospitalier Intercommunal de Créteil
Créteil, 94000
Centre Leon Berard
Lyon, 69008
Hôpital Nord - Chu Marseille
Marseille, 13915
CHU de Montpellier - Hôpital Arnaud de Villeneuve
Montpellier, 34295
Hopital Arnaud de Villeneuve
Montpellier, 34295
Institut Curie - Site de Paris
Paris, 75005
Hopital Tenon
Paris, 75020
Japan7 sites
National Cancer Center Hospital
Chūōku, 104-0045
National Cancer Center Hospital East
Kashiwa, 277-8577
The Cancer Institute Hospital of Jfcr
Kōtoku, 135-8550
Shizuoka Cancer Center
Nagaizumi-chō, 411-8777
Osaka International Cancer Institute
Osaka, 541-8567
Kindai University Hospital
Ōsaka-sayama, 589-8511
Kanagawa Cancer Center
Yokohama, 241-8515
Spain7 sites
Complejo Hospitalario Universitario A Coruña
A Coruña, 15006
Hospital Universitario Vall Dhebron
Barcelona, 08035
Ico L'Hospitalet - Hospital Duran I Reynals
L'Hospitalet de Llobregat, 08908
Hospital Universitario Ramon Y Cajal
Madrid, 28034
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Regional Universitario Malaga
Málaga, 29011
Hospital Virgen Macarena
Seville, 41009
Taiwan6 sites
Chang Gung Medical Foundation - Kaohsiung Branch
Kaohsiung City, 83301
Taichung Veterans General Hospital
Taichung, 40705
National Cheng Kung University Hospital Nckuh
Tainan, 704
National Taiwan University Hospital
Taipei, 10002
Taipei Veterans General Hospital
Taipei, 11217
Chang Gung Memorial Hospital Linkou
Taoyuan, 333
South Korea5 sites
National Cancer Center
Goyang-si, 10408
Seoul National University Bundang Hospital
Seongnam-si, 13620
Seoul National University Hospital
Seoul, 03080
Samsung Medical Center
Seoul, 06351
Asan Medical Center
Seoul, 5505
Germany2 sites
Evangelische Lungenklinik Berlin
Berlin, 13125
Universitaetsklinikum Essen
Essen, 45147
About this study
Official title: A Phase 2, Multicenter, Randomized, Open-label Study of Ifinatamab Deruxtecan (I-DXd), a B7-H3 Antibody Drug Conjugate (ADC), in Subjects With Pretreated Extensive-stage Small Cell Lung Cancer (ES-SCLC) (IDeate-Lung01)
This 2-part study intends to define the recommended Phase 2 dose of ifinatamab deruxtecan (I-DXd) based on the efficacy, safety, and pharmacokinetics (PK) results observed in participants with Extensive-stage Small Cell Lung Cancer (ES-SCLC) who received at least 1 prior line of platinum-based chemotherapy and a maximum of 3 prior lines of therapy (Part 1) and a minimum of two previous lines of systemic therapy (Part 2). This study will also investigate I-DXd anti-tumor activity in this population.
Read the detailed description
This study will consist of 2 parts: dose optimization (Part 1) and extension (Part 2). In the dose optimization part of the study (Part 1), approximately 80 participants with at least 1 prior line of platinum-based chemotherapy and a maximum of 3 prior lines of therapy will be enrolled. Two I-DXd doses will be tested (8 mg/kg once every 3 weeks and 12 mg/kg once every 3 weeks). In the extension part of the study (Part 2), approximately 70 participants with a minimum of two previous lines of systemic therapy will be enrolled. I-DXd will be administered at the selected dose of 12 mg/kg once every 3 weeks (Q3W).
In Part 1, eligible participants will be randomized in a 1:1 ratio to receive one of the two dose levels of I-DXd. Randomization will be stratified by:
- Prior receipt or of an anti-programmed death-ligand 1 (PD-[L]1) antibody (yes/no)
- The chemotherapy-free interval (CTFI) from completion of the first-line therapy to the date of documented radiological Progressive Disease of <90 days vs. ≥90 days in second-line participants as well as the number of lines of therapy. Thus, the stratification factor includes three categories: (1) second-line participants with CTFI <90 days, (2) second-line participants with CTFI ≥90 days, and (3) third- and fourth-line participants.
- Conditions
- Extensive-stage Small-cell Lung Cancer
- Being tested
- Ifinatamab Deruxtecan (I-DXd)
- Keywords
- Relapsed/Refractory Extensive-stage Small-cell Lung Cancer, DS-7300a, B7-H3 Antibody Drug Conjugate, Ifinatamab Deruxtecan, I-DXd
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ifinatamab Deruxtecan (I-DXd)Drug
Also called DS-7300a
I-DXd will be administered as an intravenous (IV) infusion on Day 1 of each 21-day cycle (every Q3W).
| Study group | Role | What they receive |
|---|---|---|
| Ifinatamab Deruxtecan (8 mg/kg) | Experimental | Participants will be randomized to receive I-DXd at 8 mg/kg. Receives: Drug: Ifinatamab Deruxtecan (I-DXd) |
| Ifinatamab Deruxtecan (12 mg/kg) | Experimental | Participants will be randomized to receive I-DXd at 12 mg/kg.
This arm will consist of participants from Part 1 and Part 2 who receive I-DXd 12 mg/kg. Receives: Drug: Ifinatamab Deruxtecan (I-DXd) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Objective Response Rate (ORR) Based on Blinded Independent Central Review (BICR) Following Treatment With I-DXd in Participants With Pretreated ES-SCLC
ORR was defined as the percentage of participants who achieved a best overall response (BOR) of confirmed Complete Response (CR) or Partial Response (PR), assessed by BICR based on RECIST version 1.1. For all target, non-target, and new lesions, CR was defined as a disappearance of all lesions and PR was defined as at least a 30% decrease in the sum of diameters of all lesions.
Measured: Up to approximately 36 months
Secondary outcomes (13)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Following Treatment With I-DXd in Participants With Pretreated ES-SCLC
TEAEs are defined as new adverse events (AEs) that occur after the dose of study drug or as AEs that were present prior to the dose of study drug but which worsened in severity after the start of study drug.
Measured: Up to approximately 36 months
Progression-Free Survival (PFS) Following Treatment With I-DXd in Participants With Pretreated ES-SCLC
PFS is defined as the time interval from the date of enrollment to the date of disease progression based on RECIST v1.1 or death due to any cause. PFS will be assessed by BICR and investigator.
Measured: From enrollment until disease progression or death (whichever occurs first), up to approximately 36 months
Duration of Response (DoR) Following Treatment With I-DXd in Participants With Pretreated ES-SCLC
DoR is defined as the time from the date of first documentation of objective tumor response (CR or PR) to the first documentation of objective tumor progression based on RECIST v1.1 or to death due to any cause, whichever occurs first. DoR will be assessed by BICR and investigator.
Measured: From enrollment until disease progression or death (whichever occurs first), up to approximately 36 months
Overall Survival (OS) Following Treatment With I-DXd in Participants With Pretreated ES-SCLC
OS is defined as the time interval from the date of enrollment to the date of death due to any cause or last contact follow-up, whichever occurs first.
Measured: From enrollment until death, up to approximately 36 months
Time to Response (TTR) Following Treatment With I-DXd in Participants With Pretreated ES-SCLC
TTR is defined as the time from the date of enrollment to the first documentation of objective tumor response (CR or PR) based on RECIST v.1.1. TTR will be assessed by BICR and investigator.
Measured: From enrollment until disease progression or death (whichever occurs first), up to approximately 36 months
Percentage of Participants With Objective Response Rate (ORR) Based on Investigator Assessment Following Treatment With I-DXd in Participants With Pretreated ES-SCLC
ORR was the defined as the percentage of participants who achieved a best overall response (BOR) of confirmed Complete Response (CR) or Partial Response (PR), assessed by investigator based on RECIST version 1.1. For all target, non-target, and new lesions, CR was defined as a disappearance of all lesions and PR was defined as at least a 30% decrease in the sum of diameters of all lesions.
Measured: Up to approximately 36 months
Disease Control Rate (DCR) Following Treatment With I-DXd in Participants With Pretreated ES-SCLC
DCR is defined as percentage of participants with BOR of CR, PR, or stable disease, according to RECIST v1.1.
Measured: Up to approximately 36 months
Maximum Plasma Concentration (Cmax) Following Treatment With I-DXd in Participants With Pretreated ES-SCLC
Cmax will be calculated using noncompartmental methods. Cmax will be assessed for I-DXd, total anti-B7-H3 antibody, and MAAA-1181a.
Measured: Cycle 1: Predose, end of infusion (EOI), 3, 6, & 24 hours post start of infusion (SOI), Days 4, 8, 15, & 22; Cycle 2: Predose & EOI; Cycle 3: Predose, EOI, 3 & 6 hours post SOI; Cycle 4, 5 & every 2 cycles up to 36 months: Predose (each cycle is 21 days)
Time to Reach Maximum Serum Concentration (Tmax) Following Treatment With I-DXd in Participants With Pretreated ES-SCLC
Tmax will be calculated using noncompartmental methods. Tmax will be assessed for I-DXd, total anti-B7-H3 antibody, and MAAA-1181a.
Measured: Cycle 1: Predose, end of infusion (EOI), 3, 6, & 24 hours post start of infusion (SOI), Days 4, 8, 15, & 22; Cycle 2: Predose & EOI; Cycle 3: Predose, EOI, 3 & 6 hours post SOI; Cycle 4, 5 & every 2 cycles up to 36 months: Predose (each cycle is 21 days)
Minimum Observed Concentration (Ctrough) Following Treatment With I-DXd in Participants With Pretreated ES-SCLC
Ctrough will be calculated using noncompartmental methods. Ctrough will be assessed for I-DXd, total anti-B7-H3 antibody, and MAAA-1181a.
Measured: Cycle 1: Predose, end of infusion (EOI), 3, 6, & 24 hours post start of infusion (SOI), Days 4, 8, 15, & 22; Cycle 2: Predose & EOI; Cycle 3: Predose, EOI, 3 & 6 hours post SOI; Cycle 4, 5 & every 2 cycles up to 36 months: Predose (each cycle is 21 days)
Area Under the Curve (AUC) Following Treatment With I-DXd in Participants With Pretreated ES-SCLC
AUC will be calculated using noncompartmental methods. AUC will be assessed for I-DXd, total anti-B7-H3 antibody, and MAAA-1181a.
Measured: Cycle 1: Predose, end of infusion (EOI), 3, 6, & 24 hours post start of infusion (SOI), Days 4, 8, 15, & 22; Cycle 2: Predose & EOI; Cycle 3: Predose, EOI, 3 & 6 hours post SOI; Cycle 4, 5 & every 2 cycles up to 36 months: Predose (each cycle is 21 days)
Terminal Half-Life (T1/2) Following Treatment With I-DXd in Participants With Pretreated ES-SCLC
T1/2 will be calculated using noncompartmental methods. T1/2 will be assessed for I-DXd, total anti-B7-H3 antibody, and MAAA-1181a.
Measured: Cycle 1: Predose, end of infusion (EOI), 3, 6, & 24 hours post start of infusion (SOI), Days 4, 8, 15, & 22; Cycle 2: Predose & EOI; Cycle 3: Predose, EOI, 3 & 6 hours post SOI; Cycle 4, 5 & every 2 cycles up to 36 months: Predose (each cycle is 21 days)
Percentage of Participants Who Have Treatment-Emergent Antidrug Antibodies (ADA) Following Treatment With I-DXd in Participants With Pretreated ES-SCLC
The immunogenicity of I-DXd will be assessed.
Measured: Cycle 1, Cycle 2, Cycle 3 and Cycle 4 Day 1: Predose; Cycle 5 Day 1 & every 2 cycles thereafter up to approximately 36 months: Predose; End of Termination Visit; 40-day Follow-up Visit (each cycle is 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2022
- Study start9 Mar 2022
- Primary completion3 Mar 2025
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Extensive-stage Small-cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Daiichi SankyoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Global Clinical Leader, Study director, Daiichi Sankyo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05280470
- Sponsor's protocol ID
- DS7300-127
- Other IDs
- 2022-000503-13, 2041220019
- Acronym
- IDeate-Lung01
- Status last verified
- Feb 2026
- First submitted
- 23 Feb 2022
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Publications
Rudin CM, Johnson ML, Paz-Ares L, Nishio M, Hann CL, Girard N, Rocha P, Hayashi H, Sakai T, Kim YJ, Hu H, Qian M, Singh J, Godard J, Tang M, Ahn MJ. Ifinatamab Deruxtecan in Patients With Extensive-Stage Small Cell Lung Cancer: Primary Analysis of the Phase II IDeate-Lung01 Trial. J Clin Oncol. 2026 Feb;44(4):261-273. doi: 10.1200/JCO-25-02142. Epub 2025 Oct 14.
PubMed 41086386
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Randomized, Open-label Study of Ifinatamab Deruxtecan (I-DXd), a B7-H3 Antibody Drug Conjugate (ADC), in Subjects With Pretreated Extensive-stage Small Cell Lung Cancer (ES-SCLC) (IDeate-Lung01)
- ClinicalTrials.gov ID
- NCT05280470
- Acronym / sponsor ID
- IDeate-Lung01 / DS7300-127
- Conditions
- Extensive-stage Small-cell Lung Cancer
- Keywords
- Relapsed/Refractory Extensive-stage Small-cell Lung Cancer, DS-7300a, B7-H3 Antibody Drug Conjugate, Ifinatamab Deruxtecan, I-DXd
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 187 participants (actual)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 9 Mar 2022 (actual)
- Primary completion
- 3 Mar 2025 (actual)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 15 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This 2-part study intends to define the recommended Phase 2 dose of ifinatamab deruxtecan (I-DXd) based on the efficacy, safety, and pharmacokinetics (PK) results observed in participants with Extensive-stage Small Cell Lung Cancer (ES-SCLC) who received at least 1 prior line of platinum-based chemotherapy and a maximum of 3 prior lines of therapy (Part 1) and a minimum of two previous lines of systemic therapy (Part 2). This study will also investigate I-DXd anti-tumor activity in this population.
Detailed description
This study will consist of 2 parts: dose optimization (Part 1) and extension (Part 2). In the dose optimization part of the study (Part 1), approximately 80 participants with at least 1 prior line of platinum-based chemotherapy and a maximum of 3 prior lines of therapy will be enrolled. Two I-DXd doses will be tested (8 mg/kg once every 3 weeks and 12 mg/kg once every 3 weeks). In the extension part of the study (Part 2), approximately 70 participants with a minimum of two previous lines of systemic therapy will be enrolled. I-DXd will be administered at the selected dose of 12 mg/kg once every 3 weeks (Q3W).
In Part 1, eligible participants will be randomized in a 1:1 ratio to receive one of the two dose levels of I-DXd. Randomization will be stratified by:
- Prior receipt or of an anti-programmed death-ligand 1 (PD-[L]1) antibody (yes/no)
- The chemotherapy-free interval (CTFI) from completion of the first-line therapy to the date of documented radiological Progressive Disease of <90 days vs. ≥90 days in second-line participants as well as the number of lines of therapy. Thus, the stratification factor includes three categories: (1) second-line participants with CTFI <90 days, (2) second-line participants with CTFI ≥90 days, and (3) third- and fourth-line participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ifinatamab Deruxtecan (8 mg/kg) | Experimental | Drug: Ifinatamab Deruxtecan (I-DXd)Participants will be randomized to receive I-DXd at 8 mg/kg. |
| Ifinatamab Deruxtecan (12 mg/kg) | Experimental | Drug: Ifinatamab Deruxtecan (I-DXd)Participants will be randomized to receive I-DXd at 12 mg/kg. This arm will consist of participants from Part 1 and Part 2 who receive I-DXd 12 mg/kg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Participants must meet all the following criteria to be eligible for enrollment into the study:
- Sign and date the informed consent form (ICF) prior to the start of any study-specific qualification procedures.
- Participant must have at least one lesion, not previously irradiated, amenable to core biopsy.
- Male or female subjects aged ≥18 years (follow local regulatory requirements if the legal age of consent for study participation is >18 years old).
- Histologically or cytologically documented ES-SCLC.
Key exclusion criteria (22 listed)
- Participants who meet any of the following criteria will be disqualified from entering the study:
- Prior treatment with orlotamab, enoblituzumab, or other 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.
- Clinically active brain metastases, spinal cord compression or leptomeningeal carcinomatosis, defined as untreated or symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms.
- Any of the following conditions within the past 6 months: cerebrovascular accident, transient ischemic attack, or another arterial thromboembolic event.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ifinatamab Deruxtecan (I-DXd)Also: DS-7300aI-DXd will be administered as an intravenous (IV) infusion on Day 1 of each 21-day cycle (every Q3W). | Drug | Ifinatamab Deruxtecan (12 mg/kg), Ifinatamab Deruxtecan (8 mg/kg) |
Primary outcome
Percentage of Participants With Objective Response Rate (ORR) Based on Blinded Independent Central Review (BICR) Following Treatment With I-DXd in Participants With Pretreated ES-SCLC
Time frame: Up to approximately 36 months
ORR was defined as the percentage of participants who achieved a best overall response (BOR) of confirmed Complete Response (CR) or Partial Response (PR), assessed by BICR based on RECIST version 1.1. For all target, non-target, and new lesions, CR was defined as a disappearance of all lesions and PR was defined as at least a 30% decrease in the sum of diameters of all lesions.
13 secondary outcomes
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Following Treatment With I-DXd in Participants With Pretreated ES-SCLC
Time frame: Up to approximately 36 months
Progression-Free Survival (PFS) Following Treatment With I-DXd in Participants With Pretreated ES-SCLC
Time frame: From enrollment until disease progression or death (whichever occurs first), up to approximately 36 months
Duration of Response (DoR) Following Treatment With I-DXd in Participants With Pretreated ES-SCLC
Time frame: From enrollment until disease progression or death (whichever occurs first), up to approximately 36 months
Overall Survival (OS) Following Treatment With I-DXd in Participants With Pretreated ES-SCLC
Time frame: From enrollment until death, up to approximately 36 months
Time to Response (TTR) Following Treatment With I-DXd in Participants With Pretreated ES-SCLC
Time frame: From enrollment until disease progression or death (whichever occurs first), up to approximately 36 months
Percentage of Participants With Objective Response Rate (ORR) Based on Investigator Assessment Following Treatment With I-DXd in Participants With Pretreated ES-SCLC
Time frame: Up to approximately 36 months
Disease Control Rate (DCR) Following Treatment With I-DXd in Participants With Pretreated ES-SCLC
Time frame: Up to approximately 36 months
Maximum Plasma Concentration (Cmax) Following Treatment With I-DXd in Participants With Pretreated ES-SCLC
Time frame: Cycle 1: Predose, end of infusion (EOI), 3, 6, & 24 hours post start of infusion (SOI), Days 4, 8, 15, & 22; Cycle 2: Predose & EOI; Cycle 3: Predose, EOI, 3 & 6 hours post SOI; Cycle 4, 5 & every 2 cycles up to 36 months: Predose (each cycle is 21 days)
Time to Reach Maximum Serum Concentration (Tmax) Following Treatment With I-DXd in Participants With Pretreated ES-SCLC
Time frame: Cycle 1: Predose, end of infusion (EOI), 3, 6, & 24 hours post start of infusion (SOI), Days 4, 8, 15, & 22; Cycle 2: Predose & EOI; Cycle 3: Predose, EOI, 3 & 6 hours post SOI; Cycle 4, 5 & every 2 cycles up to 36 months: Predose (each cycle is 21 days)
Minimum Observed Concentration (Ctrough) Following Treatment With I-DXd in Participants With Pretreated ES-SCLC
Time frame: Cycle 1: Predose, end of infusion (EOI), 3, 6, & 24 hours post start of infusion (SOI), Days 4, 8, 15, & 22; Cycle 2: Predose & EOI; Cycle 3: Predose, EOI, 3 & 6 hours post SOI; Cycle 4, 5 & every 2 cycles up to 36 months: Predose (each cycle is 21 days)
Area Under the Curve (AUC) Following Treatment With I-DXd in Participants With Pretreated ES-SCLC
Time frame: Cycle 1: Predose, end of infusion (EOI), 3, 6, & 24 hours post start of infusion (SOI), Days 4, 8, 15, & 22; Cycle 2: Predose & EOI; Cycle 3: Predose, EOI, 3 & 6 hours post SOI; Cycle 4, 5 & every 2 cycles up to 36 months: Predose (each cycle is 21 days)
Terminal Half-Life (T1/2) Following Treatment With I-DXd in Participants With Pretreated ES-SCLC
Time frame: Cycle 1: Predose, end of infusion (EOI), 3, 6, & 24 hours post start of infusion (SOI), Days 4, 8, 15, & 22; Cycle 2: Predose & EOI; Cycle 3: Predose, EOI, 3 & 6 hours post SOI; Cycle 4, 5 & every 2 cycles up to 36 months: Predose (each cycle is 21 days)
Percentage of Participants Who Have Treatment-Emergent Antidrug Antibodies (ADA) Following Treatment With I-DXd in Participants With Pretreated ES-SCLC
Time frame: Cycle 1, Cycle 2, Cycle 3 and Cycle 4 Day 1: Predose; Cycle 5 Day 1 & every 2 cycles thereafter up to approximately 36 months: Predose; End of Termination Visit; 40-day Follow-up Visit (each cycle is 21 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Derived from this study: PubMed 41086386Rudin CM, Johnson ML, Paz-Ares L, Nishio M, Hann CL, Girard N, Rocha P, Hayashi H, Sakai T, Kim YJ, Hu H, Qian M, Singh J, Godard J, Tang M, Ahn MJ. Ifinatamab Deruxtecan in Patients With Extensive-Stage Small Cell Lung Cancer: Primary Analysis of the Phase II IDeate-Lung01 Trial. J Clin Oncol. 2026 Feb;44(4):261-273. doi: 10.1200/JCO-25-02142. Epub 2025 Oct 14.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Leader study director
Daiichi Sankyo
58 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ifinatamab Deruxtecan (I-DXd) in people with Extensive-stage Small-cell Lung Cancer, run by Daiichi Sankyo at 58 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 58 sites in United States, China, France, Japan, Spain and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Objective Response Rate (ORR) Based on Blinded Independent Central Review (BICR) Following Treatment With I-DXd in Participants With Pretreated ES-SCLC (time frame: Up to approximately 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05280470, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.