A Study of [177Lu]Lu-DOTA-TATE in Newly Diagnosed ES-SCLC Patients in Combination With Carboplati… (NCT05142696) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
A Study of [177Lu]Lu-DOTA-TATE in Newly Diagnosed ES-SCLC Patients in Combination With Carboplatin, Etoposide and Atezolizumab
United States, Austria, Canada24 participantsStarted 2022-07-13
Plain-language summary
This study aims to establish a safe and well tolerated dose of \[177Lu\]Lu-DOTA-TATE in combination with carboplatin, etoposide and atezolizumab in this setting and to assess preliminary efficacy of this combination treatment versus the combination of carboplatin, etoposide, and atezolizumab.The study will be essential to assess a new potential therapeutic option in participants with this aggressive cancer type.
Who can participate
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Key Inclusion Criteria:
* Participant is \>= 18 years on the day of signing informed consent form
* Histologically or cytologically confirmed ES-SCLC
* Presence of measurable disease
* No prior systemic treatment for ES-SCLC (except the first cycle of chemotherapy with or without atezolizumab of the induction period
* ECOG status =\< 1
* Provision of tumor tissue to support exploratory biomarker analysis
* Life expectancy of \>= 6 months
Key Exclusion Criteria:
* Participant has received prior therapy with an antibody or drug against immune checkpoint pathways
* Active autoimmune diseases or history of autoimmune diseases that may relapse
* Severe chronic or active infections (including active tuberculosis, HBV, or HCV infection) requiring systemic antibacterial, antifungal or antiviral therapy within 2 weeks before Cycle 1 Day 1
* Any major surgical procedure requiring general anesthesia =\< 28 days before Cycle 1 Day 1
* History or 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial combines a radioactive drug called lutetium-177 DOTATATE with carboplatin, etoposide, and atezolizumab — that's four treatments at once — so what does my doctor think about the added safety risks compared to the standard three-drug regimen that's usually offered for extensive-stage small cell lung cancer?
2Since this trial is in Phase 1/2 and the Phase 1 portion is specifically measuring how often serious side effects and dose-limiting toxicities occur, what does my doctor think is currently known about the safety profile of this combination, and how does that uncertainty compare to sticking with standard care?
3The trial is listed as active but no longer recruiting new patients — does my doctor know whether I would have any path to access this treatment outside of the trial, such as through a compassionate use or expanded access program?
4The Phase 2 part of this study is measuring overall survival as its main goal, which means there isn't yet strong evidence that adding the lutetium-177 drug actually extends life — how does my doctor weigh that uncertainty against starting standard first-line treatment right away?
5Because lutetium-177 DOTATATE is a targeted radioactive therapy, would I need special imaging or testing first to confirm my tumor has the right receptor targets, and how would that affect my treatment timeline?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Phase 1b: Frequency of dose limiting toxicities (DLTs), Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs leading to treatment discontinuation
Timeframe: Within the first six weeks of [177Lu]Lu-DOTA-TATE treatment]
2
Phase ll: Overall survival (OS)
Timeframe: In the phase II part: From date of randomization until date of death from any cause, assessed up to 3 years (estimated final Overall Survival (OS) analysis)