First-Line Tarlatamab in Combination With Carboplatin, Etoposide, and PD-L1 Inhibitor in Subjects With Extensive Stage Small Cell Lung Cancer (ES-SCLC)

• Status: Not yet recruiting
• Trial end date: 2024-08-27
• Target enrollment: 0
• Participant gender: All

Summary

This 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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Atezolizumab; Carboplatin; Etoposide

Criteria

Inclusion 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.

Exclusion Criteria:

• 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.