For Healthcare Professionals

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

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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 atezolizumab in this setting and to assess preliminary efficacy of this combination treatment versus the combination of carboplatin, etoposide, and atezolizumab.The study will be essential to assess a new potential therapeutic option in participants with this aggressive cancer type.
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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. No prior systemic treatment for ES-SCLC (except the first cycle of chemotherapy with or without atezolizumab of the induction period
  5. ECOG status =< 1
  6. Provision of tumor tissue to support exploratory biomarker analysis
  7. 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 autoimmune diseases or history of autoimmune diseases that may relapse
  3. 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
  4. Any major surgical procedure requiring general anesthesia =< 28 days before Cycle 1 Day 1
  5. History or current diagnosis of electrocardiogram (ECG) abnormalities indicating significant risk of safety for participants participating in the study
  6. Known hypersensitivity to the active substances or any of the excipients of the study drugs
  7. 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 Details


Contition

Extensive Stage Small Cell Lung Cancer

Age

18+

Phase

PHASE1/PHASE2

Participants Needed

200

Est. Completion Date

Jun 1, 2029

Treatment Type

INTERVENTIONAL


Sponsor

Novartis

ClinicalTrials.gov NCT Identifier

NCT05142696

Study Number

CAAA601A42101

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