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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
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
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
How to Get in Touch
Daiichi Sankyo Contact for Clinical Trial Information
Sponsor contactCONTACT
