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

Launched by NOVARTIS PHARMACEUTICALS · Dec 1, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with extensive stage small cell lung cancer (ES-SCLC), which is a type of aggressive lung cancer. The researchers want to find out if combining a radioactive treatment called [177Lu]Lu-DOTA-TATE with standard chemotherapy drugs (carboplatin and etoposide) and an immunotherapy drug (atezolizumab) is safe and effective. This study is important as it could lead to better treatment options for patients diagnosed with this challenging condition.

To participate in this trial, individuals must be at least 18 years old and have a confirmed diagnosis of ES-SCLC with measurable disease. They should not have received prior systemic treatment for this cancer, and their overall health status should be good, indicated by an ECOG score of 0 or 1 (which means they are fully active or only slightly limited in their activities). Participants will receive the new treatment combination and will be monitored closely for safety and effectiveness. This study is currently recruiting participants, and it offers a chance to contribute to research that may help improve future cancer care. If you or a loved one are considering participation, it’s a good idea to discuss it with your healthcare provider to understand all the details and implications.

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Eligibility criteria

• 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 (at least one target lesion) according to RECIST v1.1 assessed by conventional computed tomography (CT) scan
• • 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