Phase 3 study of adjuvant V940 and Pembrolizumab in resected Stage II, IIIA, IIIB NSCLC
- Conditions
- Stage II, IIIA, IIIB (N2) Non-small Cell Lung CancerMedDRA version: 21.1Level: PTClassification code: 10061873Term: Non-small cell lung cancer Class: 100000004864Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-504923-20-00
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 1038
Has surgically resected and histologically confirmed diagnosis of pathological Stage II, IIIA, IIIB (with nodal involvement [N2]) squamous or nonsquamous non–small cell lung cancer (NSCLC) as 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).
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., 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., 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 the first dose of study medication.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: To compare V940 plus pembrolizumab to placebo plus pembrolizumab with respect to OS., To evaluate V940 plus pembrolizumab to placebo plus pembrolizumab with respect to DMFS as assessed by the investigator., To evaluate V940 plus pembrolizumab to placebo plus pembrolizumab with respect to LCSS., To evaluate V940 plus pembrolizumab to placebo plus pembrolizumab with respect to mean change from baseline in global health status/QoL, physical functioning, and role functioning using the EORTC QLQ-C30 and EORTC QLQ-LC24., To evaluate the safety and tolerability of V940 plus pembrolizumab.;Primary end point(s): Disease-Free Survival (DFS);Main Objective: To compare V940 plus pembrolizumab to placebo plus pembrolizumab with respect to DFS
- Secondary Outcome Measures
Name Time Method