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)
The University of Virginia Comprehensive Cancer Center seeks participants ages 18 and over with Limited-Stage Small-Cell Lung Cancer (LS-SCLC) who Have not Progressed Following Concurrent Chemoradiation Therapy. The purpose of this study is to see the efficacy (how well something works) of the study drug (tarlatamab/placebo) and whether it causes any side effects. Tarlatamab is an investigational drug that is being developed as an anticancer drug for tumors (abnormal growth of tissue) in SCLC. The study drug, tarlatamab will be compared with placebo. The placebo will look like tarlatamab but it will not contain active ingredients. A placebo has no medical effect but looks like the study drug.
In this study, you will you will have an equal chance of being placed in either tarlatamab or placebo group. Neither you nor the study doctor can choose the group you will be in. You may or may not benefit as a result of your participation in this study. However, this study may also help doctors learn things that can help other people in the future.
If you meet the study requirements and take part in it, you will be in this study for about 6 years. This includes:
• A 28-day screening period,
• A 12-month study treatment period,
• An end of study treatment visit within 14 days after the last dose of study drug if you discontinue the study,
• A safety follow-up (SFU) visit about 42 (? 5) days after the last dose of study drug, even if subsequent anti-cancer therapy has been initiated within that period and
• A long-term follow-up (LTFU) visit every 24 weeks (? 14 days) from SFU visit (or last imaging visit, whichever is later) until about 4 years after the last participant has enrolled (take part in the study), unless you withdraw consent or the study is terminated by the sponsor earlier. The long-term follow up check-ins may be done by telephone, clinic visit, or review of your medical chart.
Additional information found here: https://www.clinicaltrials.gov/study/NCT06117774?titles=dellphi-306&ran…
For questions, contact:
uvacancertrials@hscmail.mcc.virginia.edu
No Compensation