- Study Evaluating Tarlatamab After Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer (LS-SCLC) — Recruiting • Phase III • Oncology • NCT06117774.
- Sponsor: Amgen.
Verify eligibility, endpoints and current status on the original source registry before acting on this summary.
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
The primary objective of this study is to compare the efficacy of tarlatamab with placebo as assessed by progression free survival (PFS) based on blinded independent central review (BCIR) per response evaluation criteria in solid tumors v1.1 (RECIST 1.1) and on prolonging overall survival (OS).
- : -Participants are eligible to be included in the study only if all of the following criteria apply: * Participant has provided informed consent prior to initiation of any study specific activities/procedures. * Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years). * Histologically or cytologically confirmed small-cell lung cancer (SCLC). * Diagnosed and treated for LS-SCLC with concurrent chemotherapy and radiotherapy. * Has completed chemoradiotherapy without progression per RECIST 1.1 (ie, achieved complete response [CR], partial response [PR], or stable disease [SD]). * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1. * Minimum life expectancy of 12 weeks. * Adequate organ function. * Toxicities attributed to concurrent chemoradiotherapy resolved to grade ≤ 1, unless otherwise specified. Excluding alopecia or fatigue.
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.