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
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
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
EXCLUSION CRITERIA
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
Study Locations
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How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Extensive Stage Small Cell Lung Cancer
Age (in years)
18+
Phase
Phase 1
Participants needed
39
Est. Completion Date
May 3, 2028
Treatment type
Interventional
Sponsor
Novartis
ClinicalTrials.gov identifier
NCT05142696
Study number
CAAA601A42101
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