Trial comparing treatments for Small Cell Lung Cancer
Official title A Study of Ifinatamab Deruxtecan Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer
ClinicalTrials.gov ID: NCT06203210
What this study is testing
What is Ifinatamab deruxtecan (I-DXd)?
an investigational intravenous medicine being studied as a potential treatment for relapsed small cell lung cancer is designed to deliver a chemotherapy payload directly to cancer cells that express the B7‑H3 protein
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to see whether Ifinatamab Deruxtecan is as effective and safe as the treatments doctors normally choose for people whose small cell lung cancer has come back.
- Who it's for
- Adults who have small cell lung cancer that has returned after previous therapy.
- What's involved
- Participants will receive Ifinatamab Deruxtecan or the doctor‑chosen standard therapy, with regular clinic visits for medication administration and safety checks.
- Time commitment
- The trial lasts several months, with visits scheduled at regular intervals for treatment and monitoring.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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 ICF is signed.
- Has histologically or cytologically documented extensive-stage small cell lung cancer (ES-SCLC).
- The participant must provide adequate baseline tumor samples with sufficient quantity and quality of tumor tissue content.
- 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...
You likely can't join if
- Has received prior treatment with orlotamab, enoblituzumab, or other B7 homologue 3 (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...
- Has received any of the comparators used in this study or any topoisomerase I inhibitor.
- Has inadequate washout period before randomization as specified in the protocol.
- Has any of the following conditions within the past 6 months: cerebrovascular accident, transient ischemic attack, or another arterial thromboembolic...
- Has uncontrolled or significant cardiovascular (CV) disease.
See the full eligibility criteria
- 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 ICF is signed.
- Has histologically or cytologically documented extensive-stage small cell lung cancer (ES-SCLC).
- The participant must provide adequate baseline tumor samples with sufficient quantity and quality of tumor tissue content.
- 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...
- Has at least 1 measurable lesion according to RECIST v1.1 as assessed by the investigator.
- Has documentation of radiological disease progression on or after the most recent systemic therapy.
- Has ECOG PS of less than or equal to (≤)1 within 7 days prior to Cycle 1 Day 1 (C1D1).
- Participants with brain metastasis/leptomeningeal disease are eligible if protocol specified criteria are met.
- Has received prior treatment with orlotamab, enoblituzumab, or other B7 homologue 3 (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.
- Has received any of the comparators used in this study or any topoisomerase I inhibitor.
- Has inadequate washout period before randomization as specified in the protocol.
- Has any of the following conditions within the past 6 months: cerebrovascular accident, transient ischemic attack, or another arterial thromboembolic event.
- Has uncontrolled or significant cardiovascular (CV) disease.
- Has clinically significant corneal disease.
- Any history of ILD/pneumonitis irrespective of steroid use, except for a history of radiation pneumonitis that did not require steroids.
- Current diagnosis of ILD.
- 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...
- 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...
The study team makes the final eligibility decision.
Where it is enrolling
- Springdale, Arkansas, United States
- Fullerton, California, United States
- Los Angeles, California, United States
- San Francisco, California, United States
- Miami, Florida, United States
- Orlando, Florida, United States
- Chicago, Illinois, United States
- Lexington, Kentucky, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- St Louis, Missouri, United States
- Omaha, Nebraska, United States
- Lebanon, New Hampshire, United States
- East Brunswick, New Jersey, United States
- Neptune City, New Jersey, United States
- Lake Success, New York, United States
- New York, New York, United States
- Canton, Ohio, United States
- Cincinnati, Ohio, United States
- Germantown, Tennessee, United States
+ 138 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Springdale, Arkansas, United States; Fullerton, California, United States; Los Angeles, California, United States; San Francisco, California, United States; Miami, Florida, United States; Orlando, Florida, United States and 152 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.