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, Masking: NONE,

Conditions

Small Cell Lung Cancer (SCLC)

Other study ID numbers

20210004

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