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Looking for participantsPhase3

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

Sponsor: Daiichi Sankyo

NCT ID: NCT06203210

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Ifinatamab deruxtecan (drug), Topotecan (drug), Amrubicin (drug), Lurbinectedin (drug)
How long the study runs
Study runs about 67 months (dates as stated)
About the drug or intervention
Ifinatamab deruxtecan — drug: 12 mg/kg intravenous dose on Day 1 of each 21-day cycle · Topotecan — drug: Topotecan will be administered per local standard-of-care (SoC) · Amrubicin — drug: Amrubicin will be administered per local SoC · Lurbinectedin — drug: Lurbinectedin will be administered per local SoC
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
540
Started
2024-05-21
Last checked
2026-08

Plain English Summary

What is this study?

  • • Testing a new treatment for small cell lung cancer
  • • Phase3 - 540 participants
  • • 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)

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with small cell lung cancer

Where?

  • • No UK sites listed for this trial

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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).

More detail

The primary objective of this study is to assess whether treatment with I-DXd 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.

Small Cell Lung Cancer

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

met

Treatment history

Treatments you must have had:

  • ✓ only one pri
  • ✓ orlotamab
  • ✓ steroids

What the study is looking for

  • ✓Inclusion Criteria
  • ✓Participants must meet all the following criteria to be eligible for randomization into the study:
  • ✓Sign and date the agreement to take part 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...
  • ✓Has histologically or cytologically documented extensive-stage small cell lung cancer (ES-SCLC).
See the full 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 (ICF) prior to the start of any study-specific qualification procedures. 2. Adults greater than or equal to (≥)18 years or the minimum legal adult age (whichever is greater) at the time the ICF 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 \[CTFI\] (duration from stop date of the platinum agent in 1L therapy to radiological PD) 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 less than or equal to (≤)1 within 7 days prior to Cycle 1 Day 1 (C1D1). 9. Participants with brain metastasis/leptomeningeal disease are eligible if protocol specified criteria are met. 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 (CV) disease. 7. Has clinically significant corneal disease. 8. All of the following indicators of interstitial lung disease (ILD)/pneumonitis are excluded: 1. Any history of ILD/pneumonitis irrespective of steroid use, except for a history of radiation pneumonitis that did not require steroids. 2. Current diagnosis of ILD. 3. Clinical or radiographic suspicion of ILD for which the diagnosis of ILD cannot be ruled out. Radiographic findings may include presence of lung parenchymal fibrosis, combined fibrosis and emphysema (CPFE), and/or interstitial lung abnormalities such as reticular opacities, traction bronchiectasis, honeycombing, or extensive ground glass opacities. Screening computed tomography (CT) scans must be submitted for independent central radiology review and results before randomization. 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.

How to Get in Touch

Daiichi Sankyo Contact for Clinical Trial Information

Sponsor contact

CONTACT

9089926400 CTRinfo@dsi.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-08