Phase 2 Study of Tarlatamab Dosing in Patients with Small Cell Lung Cancer (SCLC)

Inclusion Criteria

• Must provide informed consent before starting any study-related activities.
• Must be 18 years or older.
• Must have a confirmed diagnosis of small cell lung cancer (SCLC) that has progressed or returned.
• Must have experienced progression or recurrence after one round of platinum-based chemotherapy.
• Must have measurable disease according to specific medical criteria within 21 days before starting the study.
• Must have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
• Must have a life expectancy of at least 12 weeks.
• Must have adequate organ function as specified in the study protocol.

Exclusion Criteria

• Have a history of non-small cell lung cancer (NSCLC) that has transformed into SCLC.
• Have symptomatic brain metastases, unless specified otherwise in the study protocol.
• Have had another cancer within the past 2 years, with some exceptions.
• Have lung diseases like interstitial lung disease or active pneumonitis.
• Have leptomeningeal disease (cancer spread to the membranes surrounding the brain and spinal cord).
• Have an active autoimmune disease requiring treatment in the past 2 years.
• Have had a solid organ transplant.
• Have had a heart attack or severe heart failure within 6 months before starting the study.
• Have had a stroke or similar event within 6 months before starting the study.
• Have an active viral infection as specified in the study protocol.
• Have an active infection needing antibiotics within 7 days before starting the study.
• Have had severe reactions to immune therapies in the past.
• Have had major surgery within 21 days before starting the study.
• Have had cancer treatment within 30 days before starting the study (14 days for chemotherapy).
• Have participated in a tarlatamab trial or received similar treatments before.
• Are currently receiving other cancer treatments, with some exceptions.
• Are taking steroids or immunosuppressive drugs within 7 days before starting the study.
• Have received live vaccines within 14 days before starting the study.
• Are participating in another clinical trial or have recently finished one.
• Women who are pregnant, breastfeeding, or planning to become pregnant during the study.
• Men with partners who are pregnant or could become pregnant, unless using contraception.
• Have allergies to any study drugs or components.
• Are unable to attend all study visits or follow study procedures.
• Have any other significant health issues that could affect safety or study results.