Phase 1b/2 Platform Study of Select Immunotherapy Combinations in Participants With Advanced Non-small Cell Lung Cancer (NSCLC)
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Study description
The study aims to test three drugs in combination with an approved drug called cemiplimab in people who have non-small cell lung cancer (NSCLC). NSCLC is the most common type of lung cancer.
In our immune system, there are immune cells that can kill cancer cells. However, some cancer cells can turn off these immune cells, making it harder for the body to fight the cancer.
Cemiplimab and the three drugs, called S095018, S095024, and S095029 (collectively called “S-compounds”), are designed to help immune cells stay turned on and prevent cancer cells from turning them off. These drugs are types of immunotherapies (a treatment that helps the immune system fight cancer). They are made to recognize and stick to specific proteins on the surface of immune cells.
This 2-part study aims to test if each of the S-compounds in combination with cemiplimab works well and is safe for patients with NSCLC. The hope is that by keeping the immune cells turned on, they will be better able to move into tumors and kill the cancer cells. Since cemiplimab and the Scompounds work in different ways to affect immune cells, combining the S-compounds with cemiplimab might increase the effect cemiplimab has on the cancer.
This research is important because it aims to improve current lung cancer treatments, potentially leading to better outcomes and longer survival for patients.
The mains goals of this study are:
- To see how safe each of the S-compounds is in combination with cemiplimab and to confirm the recommended doses for each combination (the doses that are both safe and effective) (Part A).
- To test how well each of the three treatment combinations work in treating the cancer, compared to using cemiplimab alone (Part B).
- S095018
- S095024
- S095029
- S095018 Recommended Dose Expansion (RDE)
- S095024 RDE
- S095029 RDE
- Cemiplimab
- SPLFIO-174
Eligibility Criteria
Eligible age for the study
Sex
Male/FemaleAccepts Healthy Volunteers
NoTo take part, participants have to:
- Be at least 18 years old.
- Have advanced NSCLC that has spread within the lungs (locally advanced) or to other parts of the body (metastatic).
- Have tumors with high levels of PD-L1 (a protein present on the surface of cells).
- Have not received any previous treatment for their NSCLC.
- Have no specific mutations/genetic changes in their tumor cells that can already be treated by approved targeted therapies. Targeted therapy is a type of cancer treatment that targets proteins that control how cancer cells grow, divide, and spread.
Participants cannot take part in the study if:
- Their tumors have specific genetic changes that can be treated with already approved medicines.
- They have previously been treated with medicines that help the immune system fight cancer (called immune checkpoint inhibitors).
- The cancer has spread to the brain (called brain metastases).
How is the study designed?
Given by injection into a vein on Day 1 of each 21-day cycle.
350 mg given by injection into a vein on Day 1 of each 21-day cycle.
Given by injection into a vein on Day 1 of each 21-day cycle.
350 mg given by injection into a vein on Day 1 of each 21-day cycle.
Given by injection into a vein on Day 1 of each 21-day cycle.
350 mg given by injection into a vein on Day 1 of each 21-day cycle.
Recommended dose given by injection into a vein on Day 1 of each 21-day cycle.
350 mg given by injection into a vein on Day 1 of each 21-day cycle.
Recommended dose given by injection into a vein on Day 1 of each 21-day cycle.
350 mg given by injection into a vein on Day 1 of each 21-day cycle.
Recommended dose given by injection into a vein on Day 1 of each 21-day cycle.
350 mg given by injection into a vein on Day 1 of each 21-day cycle.
350 mg given by injection into a vein on Day 1 of each 21-day cycle.