A Study of [177Lu]Lu-DOTA-TATE in Newly Diagnosed ES-SCLC Patients in Combination With Carboplatin, Etoposide and Atezolizumab
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.
Not Available
Phase I/II
Adults
Chemotherapy - cytotoxic,
Mol. targeted/Immunotherapy/Biologics
Carboplatin,
Etoposide,
Lu-dotatate
Ramirez, Robert
International
Vanderbilt University
11-04-2025
Eligibility
18 Years to 100 Years
ALL
false
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
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
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
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
