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Looking for participantsPhase3

A Study of Pembrolizumab (MK-3475) With or Without Intismeran Autogene (V940) in Participants With Non-small Cell Lung Cancer (V940-009/INTerpath-009)

Sponsor: Merck Sharp & Dohme LLC

NCT ID: NCT06623422

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Pembrolizumab (biological), Cisplatin (drug), Carboplatin (drug), Pemetrexed (drug)
How long the study runs
Study runs about 159 months (dates as stated)
About the drug or intervention
Pembrolizumab — biological: IV Infusion · Cisplatin — drug: IV infusion · Carboplatin — drug: IV infusion · Pemetrexed — drug: IV infusion · Gemcitabine — drug: IV infusion · Paclitaxel — drug: IV infusion · Intismeran autogene — biological: IM injection · Placebo — other: IM injection
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
680
Started
2024-10-21
Last checked
2026-10

Plain English Summary

What is this study?

  • • Testing a new treatment for carcinoma, non-small-cell lung
  • • Phase3 - 680 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with carcinoma, non-small-cell lung

Where?

  • • Bristol - Bristol Haematology and Oncology Centre ( Site 2072)
  • • London - ROYAL MARSDEN HOSPITAL (CHELSEA)-Lung Unit ( Site 2075)
  • • London - St Bartholomews Hospital ( Site 2052)
  • • London - Royal Free Hospital ( Site 2074)
  • • +8 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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).

Carcinoma, Non-Small-Cell Lung

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

EGFRALKPD-L1CD137

Treatment history

Treatments you must have had:

  • ✓ well controlled HIV on anti-retroviral therapy (ART)

What the study is looking for

  • ✓The main inclusion criteria include but are not limited to the following:
  • ✓Has an activity scale (ECOG) performance status of 0 or 1 within 7 days before the first dose of...
  • ✓Participants who have not achieved a pathological complete response (pCR) following completion of before surgery...
  • ✓Confirmation that epidermal growth factor receptor (EGFR)-directed therapy is not indicated as primary therapy...
  • ✓Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART)

Who cannot take part

  • ✗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
  • ✗Received prior before surgery therapy for their current NSCLC diagnosis
  • ✗Received prior systemic anticancer therapy including investigational agents other than what is specified in this...
  • ✗Received prior treatment with a cancer vaccine
See the full criteria
Inclusion Criteria: 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 Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * 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 * 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

Where Is This Study? (12 UK sites)

Bristol Haematology and Oncology Centre ( Site 2072)

Bristol BS2 8ED, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+441179230000

ROYAL MARSDEN HOSPITAL (CHELSEA)-Lung Unit ( Site 2075)

London SW3 6JJ, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator020 7352 8171

St Bartholomews Hospital ( Site 2052)

London EC1A 7BE, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator00442073777000

Royal Free Hospital ( Site 2074)

London NW3 2QG, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator0207 794 0500

Guys Hospital ( Site 2057)

London SE1 3SS, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+442071885050

Royal Marsden Hospital (Sutton) ( Site 2076)

London SW3 6JJ, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator020 8642 6011

Nottingham City Hospital ( Site 2058)

Nottingham NG5 1PB, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator00441158231851

St James University Hospital ( Site 2055)

Leeds LS9 7TF, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator00441132068225

Leicester Royal Infirmary ( Site 2051)

Leicester LE1 5WW, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator00441162585249

The Christie NHS Foundation Trust ( Site 2066)

Manchester M20 4BX, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator00441614463000

The Clatterbridge Cancer Centre ( Site 2069)

Metropolitan Borough of Wirral CH63 4JY, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator00441515565000

Queen Alexandra Hospital ( Site 2059)

Portsmouth PO6 3LY, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator02392 286000 x4078

How to Get in Touch

Toll Free Number

Sponsor contact

CONTACT

1-888-577-8839 Trialsites@msd.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-10