[177Lu]Lu-DOTA-TATE: Solution for infusion of \[177Lu\]Lu-DOTA-TATE will be administered as follows:
* 2 administrations during the induction period on either Day 3, 4 or 5 of Week 1 and on Week 7 Day 3
* 1 to 4 administrations during the maintenance period on Week 13 Day 1, Week 16 Day 1, Week 19 Day 1 and Week 22 Day 1, depending on the dose assessed
Atezolizumab: Atezolizumab 1200 mg on Day 1 from Cycle 2 every 3 weeks in induction and maintenance period
[68Ga]Ga-DOTA-TATE: 2 MBq/kg of body weight (0.054 mCi/kg), with a minimum dose of 100 MBq (2.7 mCi) and maximum dose of 200 MBq (5.4 mCi)
Carboplatin: Four cycles of carboplatin AUC 5 on Day 1 every 3 weeks (Weeks 1, 4, 7 and 10) in induction period
Etoposide: Four cycles of etoposide 100 mg/m2 on Day 1-3, every 3 weeks (Weeks 1, 4, 7 and 10) in induction period
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Phase 1b: Frequency of dose limiting toxicities (DLTs), Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs leading to treatment discontinuation — Within the first six weeks of [177Lu]Lu-DOTA-TATE treatment] A dose-limiting toxicity (DLT) is defined as an AE or abnormal laboratory value assessed as unrelated to disease, disease progression, intercurrent illness, or concomitant medications with an onset within the first cycle of initiation of \[177Lu\]Lu-DOTA-TATE treatment. The National Cancer Institute Common Terminology Criteria for Adverse events (NCI CTCAE) version 5.0 will be used for AE grading.
Phase ll: Overall survival (OS) — 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) To assess efficacy of \[177Lu\]Lu-DOTA-TATE in combination with atezolizumab, carboplatin, and etoposide (experimental arm) versus standard of care consisting of carboplatin, etoposide, and atezolizumab (control arm) in terms of overall survival
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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