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A Study of Intismeran Autogene (V940) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Non-small Cell Lung Cancer (V940-002)
Trial Status: active
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.
Inclusion Criteria
Inclusion Criteria:
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).
Exclusion Criteria:
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.
- Has received an investigational agent or has used an investigational device within 4
weeks prior to study intervention administration.
- Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in
dosing exceeding 10 mg daily of prednisone equivalent) or any other form of
immunosuppressive therapy within 7 days prior to the first dose of study medication.
- Known additional malignancy that is progressing or has required active treatment
within the past 5 years.
- Active autoimmune disease that has required systemic treatment in the past 2 years.
Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is
allowed.
- History of (noninfectious) pneumonitis/interstitial lung disease that required
steroids or has current pneumonitis/interstitial lung disease.
- Active infection requiring systemic therapy.
Additional locations may be listed on ClinicalTrials.gov for NCT06077760.