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

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. The study for each participant consists of a Screening period, a Treatment period that
includes an Induction treatment period and a Maintenance treatment period, and a
Follow-up period.

The study will consist of a Phase Ib dose escalation with concurrent backfill part and a
randomised controlled Phase II part.

During the screening period of up to 28 days before starting SCLC treatment, each
participant will be assessed for somatostatin receptor (SSTR) expression by
[68Ga]Ga-DOTA-TATE imaging PET/scan.

The dose escalation part in this study will be guided by the dose limiting toxicity (DLT)
rate observed during the DLT period. To achieve a more robust dataset and to aid dose
decisions, additional participants may be backfilled in each dose level.

Upon dedclaring RD, a 1:1 randomised Phase II with approximately 140 participants with
newly diagnosed ES-SCLC will be enrolled and receive either [177Lu]Lu-DOTA-TATE at the RD
in combination with carboplatin, etoposide and atezolizumab (experimental arm) or
carboplatin, etoposide and atezolizumab alone (control arm).