A Phase 3 Study of Tarlatamab in Limited-Stage Small-Cell Lung Cancer
Research type
Research Study
Full title
A Phase 3, Randomized, Double-blind, Placebo‑controlled, Multicenter Study of Tarlatamab Therapy in Subjects With Limited‑Stage Small-Cell Lung Cancer (LS‑SCLC) who Have not Progressed Following Concurrent Chemoradiation Therapy (DeLLphi-306)
IRAS ID
1009570
Contact name
Matthew Rodaway
Contact email
Sponsor organisation
Amgen Inc.
Clinicaltrials.gov Identifier
Research summary
Small Cell Lung Cancer (SCLC), accounts for 10% to 15% of lung cancer. We believe this study may be of importance to patients with limited stage SCLC that has progressed (become worse) after initial chemotherapy and radiation therapy. This cancer type may have an excess amount of protein markers (eg, delta like ligand 3 [DLL3]; a protein possibly causing cells to grow more quickly and multiply abnormally).\n\nThis study is being done to learn more about Tarlatamab and its efficacy (how well something works), when compared to placebo (a substance that does not have any medicine in it but looks like the study drug being tested) in people with LS-SCLC.\n\nNeither the participants nor the study doctor can choose the study drug the participants will get. Participants agree to be put into a treatment group by chance (randomized), ie, equal chance to receive either tarlatamab or placebo. This is like flipping a coin or drawing numbers out of a hat.\n\nApproximately 400 patients are expected to be enrolled globally in approximately 200 centres. The study may last up to about 6 years for each participant. This includes a screening period of up to 28 days, up to 12-month treatment period, an end of treatment visit within 14 days after the last dose of tarlatamab/placebo if the participants discontinues the study, a safety follow-up (SFU) visit about 42 days after the last dose of tarlatamab/placebo, and a long-term follow-up visit every 24 weeks from SFU visit or last imaging visit, whichever is later) until about 4 years after the last participant has taken part in the study, unless the participant withdraws consent or the study is terminated by the sponsor earlier.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
24/SC/0246
Date of REC Opinion
13 Sep 2024
REC opinion
Further Information Favourable Opinion