Adjuvant intismeran (V940) with or without pembrolizumab plus berahyaluronidase alfa for high‑risk Stage I non‑small cell lung cancer after surgery
A Phase 3, Randomized, Placebo-Controlled Study of Adjuvant Intismeran Autogene Plus Subcutaneous Pembrolizumab and Berahyaluronidase Alfa (MK-3475A) or Intismeran Autogene Monotherapy Versus Placebo in Participants With Completely Resected High-Risk Stage I Non-Small Cell Lung Cancer (INTerpath-014)
This trial will try intismeran (V940) alone or together with subcutaneous pembrolizumab plus berahyaluronidase alfa to help prevent recurrence in people with completely removed high‑risk Stage I non‑small cell lung cancer.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 876 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Merck Sharp & Dohme LLC Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy, pembrolizumab |
| Locations | 3 sites (Lincoln, Nebraska and 2 other locations) |
| Trial ID | NCT07513376 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are people with completely resected pathological Stage I (≤4 cm) NSCLC with at least one high‑risk feature (e.g., tumor >2 cm, visceral pleural invasion, lymphovascular invasion, or high‑grade histology) who have not had prior systemic or radiation therapy for this cancer and can provide required tissue and blood samples.
Not a fit: Patients without high‑risk features after surgery, or those who have already received prior systemic therapy or radiotherapy for the current Stage I NSCLC, are unlikely to match this trial’s target population and may not benefit.
Why it matters
Potential benefit: If successful, the treatment could lower the chance of cancer returning after complete surgical removal and extend the time patients remain disease‑free.
How similar studies have performed: Personalized mRNA cancer vaccines combined with checkpoint inhibitors have shown encouraging signals in other cancers (for example, melanoma), but their benefit in resected Stage I NSCLC has not been established.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Lincoln, Nebraska and 2 other locations
- NHO Revive Research Institute, LLC ( Site 3218) — Lincoln, Nebraska, United States (Recruiting)
- Renown Regional Medical Center-Renown Health Medical Oncology ( Site 3207) — Reno, Nevada, United States (Recruiting)
- One Clinical Research ( Site 0501) — Nedlands, Western Australia, Australia (Recruiting)
Study contacts
- Study coordinator: Toll Free Number
- Email: Trialsites@msd.com
- Phone: 1-888-577-8839
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.