Study on Pembrolizumab With or Without V940 for Non-Small Cell Lung Cancer
Sponsor: Merck Sharp & Dohme LLC
ClinicalTrials ID:NCT06623422
This clinical trial is exploring whether adding the drug V940 to pembrolizumab after surgery can help people with non-small cell lung cancer (NSCLC) stay cancer-free longer compared to those who receive a placebo with pembrolizumab.
Patient Parameters
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Program Overview
The purpose of this study is to find out if combining the drug V940 with pembrolizumab after surgery can help prevent non-small cell lung cancer (NSCLC) from returning in patients whose tumors did not fully respond to treatment before surgery. Researchers are comparing this combination to a placebo with pembrolizumab to see which is more effective in keeping patients cancer-free for a longer time.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of non-small cell lung cancer (NSCLC) that can be surgically removed and is at Stage II, IIIA, or IIIB (N2).
- Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Have not achieved a complete response to chemotherapy and pembrolizumab before surgery.
- Do not require treatment targeting specific EGFR mutations.
- If HIV-positive, have well-controlled HIV on anti-retroviral therapy.
- If hepatitis B positive, have been on antiviral therapy for at least 4 weeks with undetectable viral load.
- If previously infected with hepatitis C, have an undetectable viral load at screening.
Exclusion Criteria
- Have a diagnosis of small cell lung cancer or certain other types of lung tumors.
- Have a specific gene rearrangement known as ALK.
- Have received prior neoadjuvant therapy for the current lung cancer diagnosis.
- Have previously been treated with certain immune therapies targeting PD-1, PD-L1, or similar pathways.
- Have received other systemic cancer treatments not specified in this study.
- Have been treated with a cancer vaccine before.
- Have had recent radiotherapy within 2 weeks before starting the study treatment or have radiation-related side effects requiring steroids.
- Have received a live vaccine within 30 days before starting the study treatment.
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