Tests intismeran autogene with pembrolizumab after surgery for lung cancer
Tests whether adding intismeran autogene to pembrolizumab helps prevent lung cancer from returning in adults.
Key facts
- Who runs it
- Merck Sharp & Dohme LLC
- Where
- Catanzaro, Milan, Naples, Padova, Ravenna, Rome, and Verona, ItalySee the 10 sitesAlso in 30 other countries, 235 sites
- Trial code
- NCT06623422
- EU 2023-506327-29-00
- JRCT2061240105
- U1111-1293-5814
- Registry title
- A Study of Pembrolizumab (MK-3475) With or Without Intismeran Autogene (V940) in Participants With Non-small Cell Lung Cancer (V940-009/INTerpath-009)
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 680 people, planned
- Started
- 21 Oct 2024
- Expected to end
- 26 Jan 2038
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Pembrolizumab
- Cisplatin
- Carboplatin
- Pemetrexed
- Gemcitabine
- Paclitaxel
- Intismeran autogene
- Placebo
- Record updated
- 9 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with non-small cell lung cancer who had chemotherapy with pembrolizumab, then surgery, and still had cancer cells left in the removed tumor.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Non-small cell lung cancer, clinical Stage II, IIIA or IIIB (N2), that could be removed by surgery; no complete pathological response after treatment before surgery.
- Earlier treatment
- Must have had chemotherapy with pembrolizumab before surgery, and surgery. No other earlier cancer treatment, no earlier cancer vaccine, and no earlier anti-PD-1, anti-PD-L1 or anti-PD-L2 treatment other than this.
- Biomarker or test result
- No tumor-activating EGFR mutations (for example DEL19 or L858R). ALK gene rearrangements cannot be present.
Main reasons for not taking part
- Small cell lung cancer, mixed tumors with small cell parts, certain other tumor types, or a Pancoast tumor
- ALK gene rearrangement in the tumor
- Earlier anti-PD-1, anti-PD-L1 or anti-PD-L2 treatment, or earlier cancer vaccine
- Radiotherapy within 2 weeks before starting the study treatment, or radiation side effects needing corticosteroids
- Live or live-attenuated vaccine within 30 days before the first dose
The registry criteria, word for word
Show all 17 criteriaShow less
Who can take part
- The main inclusion criteria include but are not limited to the following:
- Has histologically/cytologically confirmed diagnosis of previously untreated and pathologically confirmed resectable clinical 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
Who cannot take part
- Received prior neoadjuvant therapy for their current NSCLC diagnosis
- 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
- 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, or a pancoast tumor
- 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)
- The main exclusion criteria include but are not limited to the following:
- Documentation by local test report indicating presence of anaplastic lymphoma kinase (ALK) gene rearrangements
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Which best describes your lung cancer?
- Has the cancer spread to other parts of the body, or is it too advanced to be removed by surgery?
Where in Italy
Also in 30 other countries, 235 sites
- Azienda Ospedaliero Universitaria Renato DulbeccoCatanzaro, ItalyTaking people
- Fondazione IRCCS - Istituto Nazionale dei TumoriMilan, ItalyTaking people
- Istituto Europeo di Oncologia s.r.lMilan, ItalyTaking people
- IRCCS Istituto Nazionale Tumori Fondazione PascaleNaples, ItalyTaking people
- Istituto Oncologico VenetoPadova, ItalyTaking people
- Azienda Unità Sanitaria Locale della RomagnaRavenna, ItalyTaking people
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, ItalyTaking people
- Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata FonRome, ItalyTaking people
- I.F.O. Istituti Fisioterapici OspitalieriRome, ItalyTaking people
- Centro Ricerche Cliniche di Verona s.r.l.Verona, ItalyTaking people
About the trial
What the trial wants to find out
The goal of this study is to learn if people who receive intismeran autogene and pembrolizumab after surgery are cancer-free longer than people who receive placebo and pembrolizumab. Researchers want to know if giving intismeran autogene and pembrolizumab after surgery can help prevent the cancer from coming back in people with non-small cell lung cancer (NSCLC) whose tumors did not respond completely to treatment before surgery (neoadjuvant treatment).
The 2 groups in the trial
- Pembrolizumab + Intismeran autogeneTreatment being tested
For neoadjuvant treatment, participants will receive pembrolizumab 200 mg via intravenous (IV) infusion every 3-week cycle for up to 4 cycles PLUS background chemotherapy via IV infusion (cisplatin 75 mg/m\^2 or carboplatin area under the curve \[AUC\] 5 or 6 mg/mL/min, pemetrexed 500 mg/m\^2, gemcitabine 1000 mg/m\^2, paclitaxel 175 mg/m\^2 or 200 mg/m\^2 given at a dose and combination per investigator's choice) every 3-week cycle for up to 4 cycles (total neoadjuvant treatment duration of up to \~12 weeks). 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 intismeran autogene 1 mg via intramuscular (IM) injection every 3 weeks for up to 9 doses (total adjuvant treatment duration of up to \~42 weeks).
Treatment: Pembrolizumab, Cisplatin, Carboplatin, Pemetrexed, Gemcitabine, Paclitaxel, and Intismeran autogene
- Pembrolizumab + PlaceboExisting treatment, for comparison
For neoadjuvant treatment, participants will receive pembrolizumab 200 mg via IV infusion every 3-week cycle for up to 4 cycles PLUS background chemotherapy via IV infusion (cisplatin 75 mg/m\^2 or carboplatin AUC 5 or 6 mg/mL/min, pemetrexed 500 mg/m\^2, gemcitabine 1000 mg/m\^2, paclitaxel 175 mg/m\^2 or 200 mg/m\^2 given at a dose and combination per investigator's choice) every 3-week cycle for up to 4 cycles (total neoadjuvant treatment duration of up to \~12 weeks). 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 matching placebo via IM injection every 3 weeks for up to 9 doses (total adjuvant treatment duration of up to \~42 weeks).
Treatment: Pembrolizumab, Cisplatin, Carboplatin, Pemetrexed, Gemcitabine, Paclitaxel, and Placebo
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- 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)
- Plain-language title
- Tests intismeran autogene with pembrolizumab after surgery for lung cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06623422, who can take part
- Record updated
- 9 November 2026