USO 23277
A Phase 3, Open-label, Multicenter, Randomized Study of Tarlatamab in Combination With Durvalumab vs Durvalumab Alone in Subjects with Extensive-Stage Small-Cell Lung Cancer Following Platinum, Etoposide and Durvalumab (DeLLphi-305) (20200041)
Disease Types: Lung Cancer Research
Eligibility Requirements:
Inclusion:
- Participant has provided informed consent prior to initiation of any study specific activities/procedures.
- Age >= 18 years (or >= legal adult age within the country if it is older than 18 years).
- Histologically or cytologically documented extensive-stage disease (American Joint Committee on Cancer, 2017, IV small-cell lung cancer (SCLC) [T any, N any, M1 a/b]), or T3 to T4 due to multiple lung nodules that are too extensive or have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan.
- Completed 3-4 cycles of platinum-etoposide chemotherapy with concurrent durvalumab as first-line treatment of extensive-stage (ES)-SCLC prior to enrollment, without disease progression (ongoing response or stable disease) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1.
- Minimum life expectancy > 12 weeks.
- Toxicities attributed to prior anti-cancer therapy resolved to grade < 1, unless otherwise specified, excluding alopecia or fatigue.
- Adequate organ function
Exclusion:
- Symptomatic central nervous system (CNS) metastases, or leptomeningeal disease. Participants with treated brain metastases are eligible as per protocol
- Prior history of severe or life-threatening events from any immune-mediated therapy. History of other malignancy withing the past 2 years, with some exceptions as per protocol.
- Active or prior documented autoimmune or inflammatory disorders as per protocol
- Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association > class II) within 6 months of first dose of study treatment.
- History of arterial thrombosis (e.g., stroke or transient ischemic attack) within 6 months of first dose of study treatment.
- Evidence of interstitial lung disease (ILD) or active, non-infectious pneumonitis.
- History of solid organ transplant.
- Major surgical procedures within 28 days of first dose of study treatment.
- Known human immunodeficiency virus (HIV) infection (participants with HIV infection on antiviral therapy and undetectable viral load are permitted with a requirement for regular monitoring for reactivation for the duration of treatment on study), hepatitis C infection (participants with hepatitis C that achieve a sustained virologic response after antiviral therapy are allowed), or hepatitis B infection (participants with hepatitis B surface antigen [HBsAg] or core antibody that achieve sustained virologic response with antiviral therapy are permitted with a requirement for regular monitoring for reactivation for the duration of treatment on the study).
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