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A Phase 3 Randomized Double-blind Study of Adjuvant Pembrolizumab With or Without V940 in Participants With Resectable Stage II to IIIB (N2) NSCLC not Achieving pCR After Receiving Neoadjuvant Pembrolizumab With Platinum-based Doublet Chemotherapy (INTerpath-009)

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

Fujita Tomoko

MSD K.K.

KITANOMARU SQUARE,1-13-12,Kudan-kita,Chiyoda-ku,Tokyo 102-8667,Japan

msdjrct@msd.com

MSDJRCT inquiry mailbox

MSD K.K.

KITANOMARU SQUARE,1-13-12,Kudan-kita,Chiyoda-ku,Tokyo 102-8667,Japan

+81-3-6272-1957

msdjrct@msd.com

Recruiting

Feb. 28, 2025

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

-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.

-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.

Both

Non-small cell lung cancer (NSCLC)

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).

Disease-Free Survival (DFS)

-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

+81-82-257-5596

Jan. 08, 2025

Yes

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

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