Ph 3 adjuvant pembro +/- V940 after neoadjuvant pembro+chemo in NSCLC

JRCT ID: jRCT2061240105

Registered date:16/01/2025

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Non-small cell lung cancer (NSCLC)
• Date of first enrollment: 28/02/2025
• Target sample size: 38
• Countries of recruitment: Argentina,Japan,Australia,Japan,Belgium,Japan,Brazil,Japan,Bulgaria,Japan,Canada,Japan,Chile,Japan,Colombia,Japan,Finland,Japan,France,Japan,Germany,Japan,Greece,Japan,Hungary,Japan,Ireland,Japan,Israel,Japan,Italy,Japan,Netherlands,Japan,New Zealand,Japan,Peru,Japan,Poland,Japan,Romania,Japan,Singapore,Japan,South Korea,Japan,Spain,Japan,Sweden,Japan,Taiwan,Japan,Thailand,Japan,Turkiye,Japan,United Kingdom,Japan,United States,Japan
• Study type: Interventional
• Intervention(s): After surgical resection, for adjuvant treatment, participants will receive pembrolizumab 400 mg via IV infusion every 6-week cycle for up to 7 cycles PLUS V940 1 mg or matching placebo via intramuscular (IM) injection every 3 weeks for up to 9 doses (total adjuvant treatment duration of up to ~42 weeks).

Outcome(s)

• Primary Outcome: Disease-Free Survival (DFS)

Secondary Outcome

-Overall Survival (OS)
-Distant Metastasis-Free Survival (DMFS)
-Disease-Free Survival 2 (DFS2)
-Lung Cancer Specific Survival (LCSS)
-Patient-reported outcome (PRO)
-Safety and tolerability

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

-Has histologically/cytologically confirmed diagnosis of previously untreated and pathologically confirmed resectable Stage II, IIIA, or IIIB (N2) non-small cell lung cancer (NSCLC) [American Joint Committee on Cancer (AJCC) 8th Edition].
-Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before the first dose of study intervention.
-Participants who have not achieved a pathological complete response (pCR) following completion of neoadjuvant chemotherapy and pembrolizumab followed by surgery will be eligible.
-Confirmation that epidermal growth factor receptor (EGFR)-directed therapy is not indicated as primary therapy (documentation of absence of tumor-activating EGFR mutations [eg, DEL19 or L858R]).
-Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART).
-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.

Exclude criteria

-Diagnosis of SCLC or, for mixed tumors, presence of small cell elements, or has a neuroendocrine tumor with large-cell components, or a sarcomatoid carcinoma, or a pancoast tumor.
-Documentation by local test report indicating presence of anaplastic lymphoma kinase (ALK) gene rearrangements.
-Received prior neoadjuvant therapy for their current NSCLC diagnosis.
-Received prior therapy with an anti-programmed cell death 1 (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti-programmed cell-death ligand 2 (PD-L2) agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein [CTLA-4], OX-40, CD137).
-Received prior systemic anticancer therapy including investigational agents other than what is specified in this protocol.
-Received prior treatment with a cancer vaccine.
-Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids.
-Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.

Related Information

• Primary Sponsor: Fujita Tomoko
• Secondary ID(s): NCT06623422