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Compares treatment options 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?
Ifinatamab deruxtecan is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for small cell lung cancer.
Also referred to as I-DXd.
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
- This study was 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).
- 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
- Participants must meet all the following criteria to be eligible for randomization into the study:
- Sign and date the informed consent form prior to the start of any study-specific qualification procedures.
- Adults ≥18 years or the minimum legal adult age (whichever is greater) at the time the informed consent form 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.
You likely can't join if
- Participants who meet any of the following criteria will be disqualified from entering the study:
- 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...
See the full eligibility criteria
- Participants must meet all the following criteria to be eligible for randomization into the study:
- Sign and date the informed consent form prior to the start of any study-specific qualification procedures.
- Adults ≥18 years or the minimum legal adult age (whichever is greater) at the time the informed consent form 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 of ≥30 days.
- 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 ≤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. people must require no treatment with steroids or anticonvulsants...
- Participants who meet any of the following criteria will be disqualified from entering the study:
- 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 disease.
- Has clinically significant corneal disease.
- Has any history of ILD/pneumonitis irrespective of steroid use, or current ILD, or suspected ILD, or ILD that cannot be ruled out by imaging at Screening. Participants may be eligible if they had history of radiation...
- 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's taking place
- 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
- Tampa, Florida, United States
- Chicago, Illinois, United States
- Lexington, Kentucky, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Detroit, Michigan, 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
- The Bronx, New York, United States
+ 171 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 - 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?
Study sites include 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 185 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.