Adjuvant intismeran (V940) with or without pembrolizumab plus berahyaluronidase alfa for high‑risk Stage I non‑small cell lung cancer after surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 adjuvant trial enrolls people with completely resected, high‑risk Stage I non‑small cell lung cancer to receive either intismeran (V940) alone, intismeran with subcutaneous pembrolizumab coformulated with berahyaluronidase alfa (MK‑3475A), or placebo. Intismeran is designed to stimulate the immune system against tumor‑specific targets, while pembrolizumab is an immune checkpoint inhibitor delivered subcutaneously with hyaluronidase to aid administration. Participants must provide recently resected tumor tissue and blood samples as part of the protocol and will receive study treatments after surgery to try to reduce the risk of recurrence. The primary comparison is disease‑free survival versus placebo in this surgically resected, high‑risk Stage I population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

* Has a histological diagnosis of pathological Stage I (tumor ≤4 cm) non-small cell lung cancer (NSCLC) per American Joint Committee on Cancer (AJCC) 9th Edition with at least 1of the following high-risk pathologic features as assessed locally: tumor size \>2cm, visceral pleural invasion, lymphovascular invasion, or high-grade histology
* Has undergone a complete surgical resection of the primary NSCLC
* Has not received other prior treatment outside of definitive surgery (including but not limited to chemotherapy, immunotherapy, targeted therapy, or radiotherapy) for their current Stage I NSCLC
* Has provided a tissue sample from recent surgery along with the required blood sample
* Human immunodeficiency virus (HIV)-infected participants must have well-controlled HIV on antiretroviral 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:

* Has diagnosis of any 1 of the following: small cell lung cancer (SCLC) or, for mixed tumors, presence of small cell elements, neuroendocrine tumor with large cell components, sarcomatoid carcinoma, or two synchronous primary NSCLCs
* Has any clinically significant cardiovascular disease within 12 months before randomization, including a history of coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI), valvular heart disease requiring surgical intervention, New York Heart Association Class III-IV heart failure, unstable angina, myocardial infarction (MI), pulmonary hypertension, cardiovascular accident (CVA), or hemodynamically unstable cardiac arrhythmia
* HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
* Has known additional malignancy that is progressing or has required active treatment within the past 3 years
* Has active autoimmune disease that has required systemic treatment in the past 2 years. Hormonal supplementation (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed
* Has history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
* Has active infection requiring systemic therapy other than those permitted in protocol
* Has history of stem cell/solid organ transplant
* Participants who have not adequately recovered from major surgery or have ongoing surgical complications

Where it's running

• UC Davis Comprehensive Cancer Center ( Site 3204)
  Sacramento, California, United States Recruiting
• University of Colorado Cancer Center ( Site 3268)
  Aurora, Colorado, United States Recruiting
• Smilow Cancer Center at Yale-New Haven ( Site 3253)
  New Haven, Connecticut, United States Recruiting
• UF Health Cancer Center ( Site 3257)
  Gainesville, Florida, United States Recruiting
• Illinois Cancer Care ( Site 7000)
  Peoria, Illinois, United States Recruiting
• Washington University School of Medicine ( Site 3279)
  St Louis, Missouri, United States Recruiting

+76 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Toll Free Number
• Email: Trialsites@msd.com
• Phone: 1-888-577-8839

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.