Tarlatamab/Durvalumab vs Durvalumab in ES-SCLC (Extensive Stage Small-Cell Lung Cancer)

Purpose of this Study

We are doing this study to found out if a study drug called tarlatamab is a safe and effective option for patients with extensive stage small cell lung cancer (ES SCLC). We will compare the outcomes of how people do when they get a regimen of the study combined with durvalumab versus a regimen of durvalumab on its own.

Who Can Participate?

Eligibility

Adults ages 18+ who:
  • Are diagnosed with ES SCLC
  • Have a tumor that expresses ongoing response or stable disease after completion of first-line therapy with platinum chemotherapy, etoposide, and durvalumab
For more information about who can join this study, please contact the study team at annemarie.peters@duke.edu.

Age Range

18-64

Sex/Genders

Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No

What is Involved?

Description

The study is divided into 3 primary periods: a screening period, study dosing period, end the follow-up period. If you choose to join the study, during the screening period you will:
  • Have a tumor biopsy
  • Have imaging (ECHO, CT scan, and MRI)
  • Have physical exams and blood draws
The screening period lasts about 3 weeks. If you are found to be eligible, you will proceed to the study dosing period. During this period, you will get a random assignment to 1 of 2 groups:
  • Group 1: If you are in this group, you will get the study drug in combination with durvalumab. You will get the study drug by IV 3 times for your first drug cycle (Days 1, 8, and 15). A drug cycle is a 28-day period. After Cycle 1 is done, you will get the study drug 2 times (Day 1 and 15) for every following cycle. You will also get durvalumab along with the study drug for one of the infusions in each cycle.
  • Group 2: If you are in this group, you will get durvalumab once every 28 days.
The number of cycles you go through in the study will depend on how you are responding to your assigned regimen. After you stop taking the study drug or durvalumab, we will schedule you to come in for some follow-up visits and will keep in touch with you for up to 3 years.

Locations

Duke University Hospital
Duke Raleigh Hospital

Visit Timing

Weekdays

Compensation

No

Spanish Materials Available

No

Study Details

Full Title

A Phase 3, Open-label, Multicenter, Randomized Study of Tarlatamab in Combination With Durvalumab vs Durvalumab Alone in Subjects with Extensive-Stage Small-Cell Lung Cancer Following Platinum, Etoposide and Durvalumab (DeLLphi-305) (Protocol 20200041 - Contract #364128, Site #66001)

Principal Investigator

Jeffrey
Clarke

Protocol Number

PRO00115350

NCT ID

NCT06211036

Phase

III

Enrollment Status

Pending Open to Enrollment
ClinicalTrials.gov