About the study

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).

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria

1. Participant is >= 18 years on the day of signing informed consent form
2. Histologically or cytologically confirmed ES-SCLC
3. Presence of measurable disease (at least one target lesion) according to RECIST v1.1 assessed by conventional computed tomography (CT) scan
4. SSTR positive [68Ga]Ga-DOTA-TATE imaging positron emission tomography (PET) scan demonstrating uptake in at least one target or non-target lesion
5. No prior systemic treatment for ES-SCLC
6. ECOG status =< 1
7. Provision of tumor tissue to support exploratory biomarker analysis
8. Life expectancy of >= 6 months Key

Exclusion criteria

1. Participant has received prior therapy with an antibody or drug against immune checkpoint pathways
2. Active leptomeningeal disease or uncontrolled, untreated brain metastasis
3. Active autoimmune diseases or history of autoimmune diseases that may relapse
4. 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
5. Any major surgical procedure requiring general anesthesia =< 28 days before Cycle 1 Day 1
6. History or current diagnosis of electrocardiogram (ECG) abnormalities indicating significant risk of safety for participants participating in the study
7. Known hypersensitivity to the active substances or any of the excipients of the study drugs
8. Concurrent participation in another therapeutic clinical study

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.