A Phase 2 Study of Tarlatamab in Small Cell Lung Cancer (DeLLphi-309)
Research type
Research Study
Full title
A Phase 2, Open-label, Randomized, Multicenter Study of Tarlatamab Dosing Regimens in Subjects with Small Cell Lung Cancer (SCLC) (DeLLphi-309)
IRAS ID
1010913
Contact name
Matthew Rodaway
Contact email
Sponsor organisation
Amgen Inc.
Eudract number
2024-516051-40
Clinicaltrials.gov Identifier
Research summary
This study is being done to learn more about tarlatamab in people with Small Cell Lung Cancer (SCLC). It will see how well tarlatamab works and whether it causes any side effects. This study will also look at what doses of tarlatamab are safe for people to take. Participants will be given tarlatamab as an intravenous infusion (through a tube placed into a vein usually in their arm) every 2 weeks, every 3 weeks, or every 4 weeks depending on which group they are enrolled in. The information from this study might help to find more treatments in the future for SCLC. Participants will be in this study for up to 52 months, this includes, a 21-day screening period, a treatment period, the duration of which depends on how the participants SCLC responds to and how their body tolerates tarlatamab, a safety follow up (SFU) visit about 60 days after the last dose of investigational product, and a long-term follow up (LTFU) visit every 12 weeks for up to 3 years from SFU visit (or last imaging visit, whichever is later). The long-term follow-up check-ins may be done by telephone, study site visit, or review of the participants medical chart until about 3 years after the last participant is enrolled. About 240 people will take part in this study, out of which about 3 will be from the UK. This study will take place in about 80 centres in Argentina, Australia, Belgium, Brazil, China, France, Germany, Greece, Italy, Japan, South Korea, Spain, Switzerland, Türkiye, United Kingdom and United States.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
25/EM/0057
Date of REC Opinion
16 Apr 2025
REC opinion
Further Information Favourable Opinion