For Healthcare Professionals

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

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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).
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Who can take part

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

INCLUSION CRITERIA

Key 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

EXCLUSION CRITERIA

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
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Study Locations

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

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 1-888-669-6682Email iconEmail Study Center

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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