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

Trial number:
NCT05740566
Trial phase:
3
Study type:
Chemotherapy
Overall status:
Recruiting

Study start date

May, 2023

Scientific title

A Randomized, Open-label, Phase 3 Study of Tarlatamab Compared With Standard of Care in Subjects With Relapsed Small Cell Lung Cancer After Platinum-based First-line Chemotherapy

Summary

The main objective is to compare the efficacy of tarlatamab with standard of care (SOC) on prolonging overall survival (OS).

Participant has provided informed consent prior to initiation of any study specific activities/procedures.Age ≥ 18 years (or legal adult age within country, whichever is older) at the time of signing the informed consent. Histologically or cytologically confirmed SCLC with demonstrated progression or relapse. Participants who progressed or recurred following 1 platinum-based regimen. Measurable disease as defined per RECIST 1.1 within the 21-day screening period. Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1. Minimum life expectancy of 12 weeks. Adequate organ function.

Study design

Primary purpose: Treatment, Allocation: Randomized, Intervention model: Parallel Assignment, Masking: None (Open Label),

Conditions

Small Cell Lung Cancer (SCLC)

Other study ID numbers

20210004

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