RecruitingNon-small Cell Lung Cancer

A Study of Intismeran Autogene (V940) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Non-small Cell Lung Cancer (V940-002)

Eligible age

18+ yrs

Accepts

All genders

Locations

29 states

Healthy volunteers

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About this study

The goal of this study is to evaluate intismeran autogene plus pembrolizumab versus placebo plus pembrolizumab for the adjuvant treatment of margin negative, completely resected Stage II, IIIA, IIIB (with nodal involvement \[N2\]) non-small cell lung cancer (NSCLC). The primary hypothesis is that intismeran autogene plus pembrolizumab is superior to placebo plus pembrolizumab with respect to disease-free survival (DFS) as assessed by the investigator.

Sponsor: Merck Sharp & Dohme LLC

You may qualify if…

✓ The main inclusion criteria include but are not limited to the following:
✓ Has undergone margin negative, completely resected non-small cell lung cancer (NSCLC), and has pathological Stage II, IIIA, IIIB (N2) squamous or nonsquamous tumor, node, metastasis (TNM) staging per American Joint Committee on Cancer (AJCC) Eighth Edition guidelines.
✓ Has no evidence of disease before randomization.
✓ Has received at least one dose of adjuvant treatment with standard of care platinum doublet chemotherapy.
✓ No more than 24 weeks have elapsed between surgical resection of curative intent and the first dose of pembrolizumab.
✓ Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization.
✓ Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening.
✓ Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART).

You may not qualify if…

✕ The main exclusion criteria include but are not limited to the following:
✕ Diagnosis of small cell lung cancer (SCLC) or, for mixed tumors, presence of small cell elements, or has a neuroendocrine tumor with large cell components or a sarcomatoid carcinoma.
✕ HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
✕ Received prior neoadjuvant therapy for their current NSCLC diagnosis.
✕ Received or is a candidate to receive radiotherapy for their current NSCLC diagnosis.
✕ Received prior therapy with an anti-programmed cell death 1 protein (PD-1), anti-PD-ligand 1 (L1), or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor.
✕ Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.
✕ Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.