A Safety Study of [177Lu]Lu-DOTA-TATE in Newly Diagnosed Extensive Stage Small Cell Lung Cancer (ES-SCLC) Patients in Combination With Carboplatin, Etoposide and Tislelizumab

• Status: Not yet recruiting
• Trial end date: 2025-06-16
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to establish a safe and well tolerated dose of [177Lu]Lu-DOTA-TATE in combination with carboplatin, etoposide, and tislelizumab in induction treatment and with tislelizumab in maintenance treatment in newly diagnosed patients with Extensive Stage Small Cell Lung Cancer (ES-SCLC).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: 1,4,7,10-tetraazacyclododecane- 1,4,7,10-tetraacetic acid; Carboplatin; Etoposide; Lutetium Lu 177 dotatate

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

• SSTR positive [68Ga]Ga-DOTA-TATE imaging positron emission tomography (PET) scan demonstrating uptake in at least one target or non-target lesion

• No prior systemic treatment for ES-SCLC

• 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 leptomeningeal disease or uncontrolled, untreated brain metastasis

• 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