A Phase 3 Study of Tarlatamab Vs Standard of Care in Relapsed Small Cell Lung Cancer
Research type
Research Study
Full 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 (DeLLphi-304)
IRAS ID
1007425
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 relapsed SCLC that has progressed (become worse) after initial platinum-based treatment. 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).
This study is being done to learn more about tarlatamab compared to standard of care (SOC) chemotherapy in people with SCLC. The purpose of this study is to see the efficacy (how well something works) of study treatment tarlatamab compared to the SOC chemotherapy and whether it causes any side effects.
Approximately 700 patients are expected to be enrolled globally in approximately 200 centres. This study will be carried out over 5 years however the duration on treatment will vary depending on how well the patients cancer responds to Tarlatamab/SOC chemotherapy.
The study duration will consist of an optional prescreen period to collect tumour tissue, 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/SOC. Long-term follow up assessments will also be conducted by site visit, telephone or chart review every 12 weeks for about 3 years after the last participants’ last dose of tarlatamab unless the patient withdraws consent or the study is terminated by the Sponsor earlier.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
23/SC/0246
Date of REC Opinion
18 Oct 2023
REC opinion
Further Information Favourable Opinion