Study Comparing Tarlatamab With Standard of Care Chemotherapy in Relapsed Small Cell Lung Cancer

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 700

Inclusion Criteria

1. Participant has provided informed consent prior to initiation of any study specific activities/procedures.
2. Age >= 18 years (or legal adult age within country, whichever is older) at the time of signing the informed consent.
3. Histologically or cytologically confirmed relapsed/refractory SCLC.
4. Participants who progressed or recurred following 1 platinum-based regimen.
5. Provision of evaluable tumor sample for central testing.
6. Measurable disease as defined per RECIST 1.1 within the 21-day screening period.
7. Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1.
8. Minimum life expectancy of 12 weeks.
9. Adequate organ function.

Exclusion Criteria

Disease Related
1. Untreated or symptomatic central nervous system (CNS) metastases with exceptions defined in the protocol.
2. Diagnosis or evidence of leptomeningeal disease.
3. Prior history of immune checkpoint inhibitors resulting in events defined in the protocol.

Other Medical Conditions
4. Active autoimmune disease that has required systemic treatment (except replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy.
5. History of solid organ transplantation.
6. History of other malignancy within the past 2 years, with exceptions defined in the protocol.
7. Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association >class II) within 12 months prior to first dose of study treatment.
8. History of arterial thrombosis (eg, stroke or transient ischemic attack) within 12 months prior to first dose of study treatment.
9. Exclusion of HIV and hepatitis infection based on criteria per protocol.
10. Receiving systemic corticosteroid therapy or any other form of immunosuppressive therapy within 7days prior to first dose of study treatment.
11. Symptoms and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection requiring antibiotics within 7 days prior to the first dose study treatment.
12. Evidence of interstitial lung disease or active, non-infectious pneumonitis.

Prior/Concomitant Therapy
13. Prior therapy with tarlatamab or any of the standard of care chemotherapy included as part of this trial.
14. Prior therapy with any selective inhibitor of the DLL3 pathway.
15. Participant received more than one prior systemic therapy regimen for SCLC.
16. Prior anti-cancer therapy within 21 days prior to first dose of study treatment with exceptions defined in protocol.
17. Current anti-cancer therapy such as chemotherapy, immunotherapy, or targeted therapy with exceptions.
18. Use of herbal or prescription/non-prescription medications known to inhibit membrane transporters P-glycoprotein (P-gp) and/or breast cancer resistance protein (BCRP) within 7 days prior to the first dose of study treatment.
19. Use of herbal or prescription/non-prescription medications known to be moderate or strong inhibitors of cytochrome P450 3A (CYP3A) enzymes within 7 days prior to the first dose of study treatment.
20. Use of herbal or prescription/non-prescription medications known to be moderate or strong inducers of CYP3A enzymes within 28 days prior to first dose of study treatment.
21. Participants who have reached the limit dose of prior treatment with cardiotoxic drugs.
22. Major surgical procedures within 28 days prior to first dose of study treatment.
23. Live and live-attenuated vaccines within 14 days prior to the start of study treatment. Inactive vaccines and live viral non-replicating vaccines within 3 days prior to the first dose of study treatment.
24. Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded.

Diagnostic Assessments
25. Any previous diagnosis of transformed non-small cell lung cancer (NSCLC), epidermal growth factor receptor (EGFR) activating mutation positive NSCLC that has transformed to SCLC, or mixed SCLCNSCLC histology.

Other Exclusions
26. Female participants of childbearing potential unwilling to use protocol spec

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Overall Survival (OS) [ Time Frame: Up to approximately 5 years ]

Secondary Outcome Measures

Name	Time	Method

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