A Phase 1b Study Evaluating the Safety and Efficacy of First-Line Tarlatamab in Combination With Carboplatin, Etoposide, and PD-L1 Inhibitor in Subjects With Extensive Stage Small Cell Lung Cancer
Brief SummaryThis is a phase 1b study to assess the safety and tolerability of tarlatamab in combination with programmed death ligand (PD-L1) inhibition with and without chemotherapy.
Inclusion and Exclusion Criteria
- Participant has provided informed consent prior to initiation of any study specific activities/procedures.
- Age greater than or equal to 18 years old at the same time of signing the informed consent.
- Histologically or cytologically confirmed Extended Stage Small Cell Lung Cancer (ES-SCLC) and no prior systemic treatment for ES-SCLC
- Eastern Cooperative Oncology Group (ECOG) 0 to 1.
- Participants with treated asymptomatic brain metastases are eligible provided they meet defined criteria.
- Adequate organ function as defined in protocol.
- History of other malignancy within the past 2 years with exceptions.
- Major surgery within 28 days of study day 1.
- Untreated or symptomatic brain metastases and leptomeningeal disease.
- Participants who experienced recurrent grade 2 pneumonitis or severe or life-threatening immune-mediated adverse events or infusion-related reactions including those that lead to permanent discontinuation while on treatment with immuno-oncology agents.
- History of immune-related colitis.
- History or evidence of interstitial lung disease or active, non-infectious pneumonitis.
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment.
- History of solid organ transplantation.
- History of hypophysitis or pituitary dysfunction.
- Active autoimmune disease that has required systemic treatment (except replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy while on study. Participants with Type I diabetes, vitiligo, psoriasis, hypo- or hyper-thyroid disease not requiring immunosuppressive treatment are permitted.
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.