Featured Trial

A Phase 2 Randomized, Open label, Multicenter Study to Evaluate the Optimal Dose, Safety, and Efficacy of ABBV‑706 in Combination with Atezolizumab versus Standard of Care as First‑Line Treatment in Subjects with Previously Untreated Extensive Stage Small Cell Lung Cancer (ES‑SCLC)

Study Identifier
M24-633
CT.gov Identifier
NCT07155174
EudraCT Identifier
Not available
EUCTIS ID
2024-517490-24
For general inquiries, please contact

844-663-3742 or [email protected]

Recruiting
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Study Details

The SEZanne study is for adults with extensive stage small cell lung cancer (ES-SCLC) who have not received any previous treatment for this condition. ES-SCLC is an aggressive neuroendocrine tumor that metastasizes quickly and is difficult to treat. The study will test the investigational study treatment ABBV-706, an antibody drug conjugate (ADC) designed to inhibit tumor growth, in combination with the immunotherapy drug atezolizumab to see if they can safely extend clinical outcomes compared to the existing ES-SCLC standard of care. The study compares the new investigational study treatment combination to standard treatments to see which works better and is safer.

Study Details

Medical Condition
  • Lung Cancer - Small Cell Lung Cancer (SCLC)
    • Study Drug
  • ABBV-706
  • Atezolizumab
  • Etoposide
  • Carboplatin
  • Lurbinectedin
    • Phase
    Phase 2
    Estimated Enrollment
    180 patients

    Participating in our Clinical Trials

    In this randomized study, researchers will assess the optimal dose for the investigational study treatment ABBV-706 to ensure both clinical benefit and tolerability for the patient. The progress of the tumor will be monitored at intervals throughout the study.

    If you join, you’ll receive regular IV infusions of the study drugs. You’ll have frequent check-ups, blood tests, and scans to assess your health and how the treatment is working. You’ll be closely monitored for side effects, and you can leave the study at any time.

    Study Participant Requirements

    Sex
    Female & Male
    Age
    18+ years

    Key Inclusion and Exclusion Criteria

    Participants must:

    • Be 18 years or older
    • Have been diagnosed with extensive stage small cell lung cancer (ES-SCLC) that needs first-line treatment and have at least one tumor that can be measured on scans
    • Are able to do most daily activities on your own (ECOG performance status 0 or 1)

    Participants must not:

    • Have received any prior treatment for small cell lung cancer or have a different type of lung cancer
    • Have a history of certain lung problems (like interstitial lung disease or pneumonitis) or active lung issues on a chest scan
    • Have serious health issues that would make treatment unsafe or interfere with participation (such as severe heart, liver, or kidney problems, or recent major surgery)

    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Diagnosis of histologically or cytologically confirmed extensive stage small cell lung cancer (ES-SCLC) requiring treatment with first line therapy. * Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 during the screening period prior to the first dose of study treatment. * Have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST v1.1). * Suspected brain metastases at screening should have a computed tomography (CT)/ magnetic resonance imaging (MRI) of the brain prior to study entry.
    Exclusion Criteria:
    * Have received any kind of treatment for limited stage small cell lung cancer (LS-SCLC). * Known active/symptomatic central nervous system (CNS) metastases should be excluded. * History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, or any evidence of active ILD/pneumonitis on screening chest computed tomography (CT) scan should be excluded. * Have any clinically significant conditions that would adversely affect the participant's participation in the study, and the subject should have a life expectancy of at least 3 months.

    Study Locations

    Location
    Status
    Location
    Yale University School of Medicine /ID# 278181
    New Haven, Connecticut, United States, 06510
    Status
    Recruiting
    Location
    Ocala Oncology Center /ID# 278269
    Ocala, Florida, United States, 34474
    Status
    Recruiting
    Location
    Moffitt Cancer Center /ID# 277573
    Tampa, Florida, United States, 33612
    Status
    Recruiting
    Location
    Fort Wayne Medical Oncology And Hematology /ID# 277336
    Fort Wayne, Indiana, United States, 46804
    Status
    Recruiting
    Location
    Baptist Health Lexington /ID# 277729
    Lexington, Kentucky, United States, 40503
    Status
    Recruiting
    Location
    Dana-Farber Cancer Institute /ID# 277732
    Boston, Massachusetts, United States, 02215
    Status
    Recruiting
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