A Study of [177Lu]Lu-DOTA-TATE in Newly Diagnosed ES-SCLC Patients in Combination With Carboplatin, Etoposide and Atezolizumab

Condition(s) studied

Investigational drug(s) / intervention(s)

[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

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

Trial sites (27)

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