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)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-506327-29-00

Acronym

V940-009

Enrollment

473

Registered

2024-11-18

Start date

2025-05-14

Completion date

Unknown

Last updated

2025-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Small Cell Lung Cancer

Brief summary

Disease- Free Survival (DFS)

Detailed description

Overall survival (OS), Distant Metastasis-Free Survival (DMFS), Disease- Free Survival 2 (DFS2), Lung Cancer Specific Survival (LCSS), Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30), Change from Baseline in the EORTC QLQ-C30 Physical Functioning (Items 1-5), Change from Baseline in the EORTC QLQ-C30 Role Functioning (Items 6 and 7), Number of participants with ≥1 adverse event (AE), Number of participants discontinuing from study therapy due to AE(s)

Interventions

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

DRUGCARBOPLATIN

DRUGmRNA-4157

DRUGCISPLATIN

DRUGPEMETREXED

DRUGPACLITAXEL

DRUGGEMCITABINE

DRUGplacebo for mRNA-4157

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Disease- Free Survival (DFS)	—

Secondary

Measure	Time frame
Overall survival (OS), Distant Metastasis-Free Survival (DMFS), Disease- Free Survival 2 (DFS2), Lung Cancer Specific Survival (LCSS), Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30), Change from Baseline in the EORTC QLQ-C30 Physical Functioning (Items 1-5), Change from Baseline in the EORTC QLQ-C30 Role Functioning (Items 6 and 7), Number of participants with ≥1 adverse event (AE), Number of participants discontinuing from study therapy due to AE(s)	—

Measure

Time frame

—

Countries

Belgium, Bulgaria, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Netherlands, Poland, Romania, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026