Purpose of this Study
In this study, people go through a screening period and testing to learn more about their cancer. Based on special features of the cancer, called biomarkers, they are placed into one of three groups. In each group, people are also placed by chance into one of two treatment options.
In all groups, one option is to receive a medicine called durvalumab. The other option is to receive durvalumab together with another medicine. The extra medicine depends on the group and may be saruparib, ceralasertib, or monalizumab.
The goal of the study is to see which treatment works best for different types of cancer based on their specific features.
Who Can Participate?
Eligibility
People can join this study if they are 18 years old or older and have a certain type of lung cancer called extensive stage small cell lung cancer. They must not have another cancer that could affect the study, and they must not have had an earlier stage of this lung cancer in the past.
Some people can join if they have not started treatment yet and plan to begin standard chemotherapy with a medicine called durvalumab. Others can join if they have already started this treatment and completed a few cycles. People cannot join if they have had certain types of immunotherapy before or if they are taking other cancer treatments at the same time.
Age Range
18-110
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 screening part of this study is used to learn more about each persons tumor. Doctors will test the tumor to see which type it is, called subtypes A, N, P, or I, and to check for a protein called SLFN11. These results are needed to decide if a person can join the treatment part of the study.
This screening also helps researchers learn if these tests can help doctors choose the best treatment for each patient based on the specific features of their cancer.
Locations
Duke University Hospital
Duke Raleigh Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
Yes
Study Details
Full Title
Protocol S2409, PRISM: PRecIsion in SCLC via a Multicohort Study: Randomized Phase II studies evaluating maintenance Durvalumab with or without Biomarker-Directed Therapy for Extensive Stage Small Cell Lung Cancer (ES-SCLC) (NCT# 06769126)
Principal Investigator
Laura
Alder
Protocol Number
PRO00119900
NCT ID
NCT06769126
Phase
II
Enrollment Status
Open to Enrollment