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A Study of [177Lu]Lu-DOTA-TATE in Newly Diagnosed ES-SCLC Patients in Combination With Carboplatin, Etoposide and Atezolizumab
Trial Status: active
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.
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
Additional locations may be listed on ClinicalTrials.gov for NCT05142696.
Locations matching your search criteria
United States
District of Columbia
Washington
MedStar Georgetown University Hospital
Status: Temporarily closed to accrual
Name Not Available
Kentucky
Lexington
University of Kentucky/Markey Cancer Center
Status: Active
Name Not Available
New Jersey
Hackensack
Hackensack University Medical Center
Status: Active
Name Not Available
Ohio
Cleveland
Case Comprehensive Cancer Center
Status: Active
Name Not Available
Pennsylvania
Philadelphia
Fox Chase Cancer Center
Status: Active
Name Not Available
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 declaring 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).
Trial PhasePhase I/II
Trial Typetreatment
Lead OrganizationNovartis Pharmaceuticals Corporation
