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A Study of [177Lu]Lu-DOTA-TATE in Newly Diagnosed ES-SCLC Patients in Combination With Carboplatin, Etoposide and Atezolizumab.
EU CTIS ID: 2024-513185-19-00
What this study is testing
Phase Ib: To establish the recommended dose of [177Lu]Lu-DOTA-TATE in combination with carboplatin, etoposide, and atezolizumab in induction treatment and with atezolizumab in maintenance treatment in newly diagnosed participants with ES-SCLC Phase II: To assess efficacy of [177Lu]Lu-DOTA-TATE in combination with carboplatin, etoposide and atezolizumab (experimental arm) versus standard of care consisting of carboplatin, etoposide, and atezolizumab (control arm) in terms of overall survival
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- • Participant is ≥ 18 years on the day of signing informed consent form • Histologically or cytologically confirmed ES-SCLC • Presence of measurable disease (at least one target lesion) according to RECIST v1.1 assessed by conventional computed tomography (CT) scan • SSTR positive [68Ga]Ga-DOTA-TATE imaging positron emission tomography (PET) scan demonstrating uptake equal or higher than the liver uptake (uptake intensity score 2 or above in the visual uptake scoring scale) in at least one target or non-target lesion • No prior systemic treatment for ES-SCLC (except the first cycle of chemotherapy with or without atezolizumab of the induction period) • Provision of tumor tissue to support exploratory biomarker analysis •Life expectancy of >=6 months
You likely can't join if
- • Participant has received prior therapy with an antibody or drug against immune checkpoint pathways • Active leptomeningeal disease or uncontrolled, untreated brain metastasis • Any major surgical procedure requiring general anesthesia =< 28 days before Cycle 2 Day 1 • History of current diagnosis of electrocardiogram (ECG) abnormalities indicating significant risk of safety for participants participating in the study • Known hypersensitivity to the active substances or any of the excipients of the study drugs • Concurrent participation in another therapeutic clinical study
The study team makes the final eligibility decision.
Where it's taking place
- United States
- United Kingdom
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; United Kingdom. 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 EU CTIS; the study team decides eligibility.