A Phase 2 Study of Tarlatamab in Participants with SCLC (DeLLphi-301)
Research type
Research Study
Full title
A Phase 2 Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacokinetics of Tarlatamab in Subjects with Relapsed/Refractory Small Cell Lung Cancer After Two or More Prior Lines of Treatment
IRAS ID
304193
Contact name
Fiona Blackhall
Contact email
Sponsor organisation
Amgen Ltd
Eudract number
2021-002566-40
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 5 months, 17 days
Research summary
This study will be conducted in 2 parts. Both parts will enroll participants with advanced Small cell lung cancer (SCLC). The purpose of Part 1 of the study is to find out dose levels of tarlatamab. The purpose of Part 2 (dose expansion phase) is to further assess the safety of the selected dose level of tarlatamab and understand their effect on the tumour.
The main aim of this study is to evaluate safety and effectiveness of 2 dose levels of tarlatamab for Part 1 only and evaluate anti-tumour activity of tarlatamab for Part 1 and Part 2.
A total of approximately 160 people are expected to participate in Part 1 and 2 of this study. Approximately 120 subjects in Part 1 [~60 at each dose level] and 40 subjects in Part 2). Part 1 will be performed to choose the dose level of tarlatamab for use in Part 2. Part 2 of this study will be the expansion phase for the selected dose from Part 1
The study duration for participants will be approximately up to 24 months. The study duration will consist of up to 21 days for screening, a variable period on treatment, and a safety follow-up period of up to approximately 42 days after the last dose of tarlatamab. Long-term follow up assessments will also be conducted by site visit, telephone or chart review to assess for survival and/or the start of subsequent cancer therapy every 3 months for up to 1 year after the last participants’ last dose of tarlatamab or 5 years from first participant enrolled, whichever occurs first. Approximately 100 sites will be included in the study.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
22/NE/0020
Date of REC Opinion
24 Mar 2022
REC opinion
Further Information Favourable Opinion