What is intismeran studying for non-small cell lung cancer?

Intismeran is being studied to see if it can help prevent the return of high-risk Stage I non-small cell lung cancer after surgery. Researchers want to learn if intismeran alone or combined with pembrolizumab and berahyaluronidase alfa improves disease-free survival. The study is sponsored by Merck Sharp & Dohme LLC to explore new treatment options for this cancer type.

Who may be eligible for this non-small cell lung cancer clinical trial?

Adults aged 18 years or older with completely removed high-risk Stage I non-small cell lung cancer may be eligible. Both men and women can participate. Important criteria include no prior treatments except surgery, no active autoimmune disease needing recent systemic therapy, and controlled HIV or hepatitis infections if applicable. Please review eligibility criteria for more details.

Is there any cost to participate in this non-small cell lung cancer clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel or accommodation costs during the study.

Actively Recruiting

Phase 3

Age: 18Years +

All Genders

ID07513376

A Phase 3, Randomized, Placebo-Controlled Study of Adjuvant Intismeran Autogene Plus Subcutaneous Pembrolizumab and Berahyaluronidase Alfa or Intismeran Monotherapy Versus Placebo in Completely Resected High-Risk Stage I Non-Small Cell Lung Cancer

Led by Merck Sharp & Dohme LLC · Updated on 2026-05-28

876

Participants Needed

Research Sites

194 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are investigating new treatments for people with high-risk, localized non-small cell lung cancer NSCLC that has been completely removed by surgery. This study aims to learn if one or two investigational treatments can help prevent the cancer from returning. The main goal is to see if adjuvant intismeran autogene V940, given alone or combined with subcutaneous pembrolizumab and berahyaluronidase alfa, improves disease-free survival compared to placebo in patients with completely resected high-risk Stage I NSCLC. Participants will be randomly assigned to one of three groups one group receives intismeran via intramuscular injection plus pembrolizumab coformulated with berahyaluronidase alfa via subcutaneous injection another group receives only intismeran via intramuscular injection and the third group receives a placebo injection matching the intismeran dose. The study treatments are given to evaluate their effects on preventing cancer recurrence after surgery. During the study, participants will be monitored for disease-free survival through blinded independent central review for up to approximately 98 months. Additional measures include distant metastasis-free survival, overall survival, and quality of life assessments. Researchers will also track adverse events and study treatment discontinuations for up to about 144 months. Participants will provide tissue and blood samples and undergo regular assessments to evaluate safety and treatment effects throughout the study period.

CONDITIONS

Brief Title

A Clinical Trial of Adjuvant Intismeran (V940) With or Without Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) in High-Risk Stage I Non-Small Cell Lung Cancer (V940-014)

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Histological diagnosis of pathological Stage I non-small cell lung cancer (tumor ≤4 cm) with at least one high-risk feature: tumor size >2 cm, visceral pleural invasion, lymphovascular invasion, or high-grade histology
Complete surgical resection of the primary NSCLC
No prior treatment except definitive surgery for current Stage I NSCLC
Provided tissue sample from recent surgery and required blood sample
HIV-infected participants must have well-controlled HIV on antiretroviral therapy
Hepatitis B surface antigen positive participants must have received antiviral therapy for at least 4 weeks with undetectable viral load
Participants with history of hepatitis C infection must have undetectable viral load at screening

You will not qualify if you...

Diagnosis of small cell lung cancer, mixed tumors with small cell elements, neuroendocrine tumor with large cell components, sarcomatoid carcinoma, or two synchronous primary NSCLCs
Clinically significant cardiovascular disease within 12 months before randomization, including recent heart procedures or severe heart failure
HIV-infected participants with history of Kaposi's sarcoma or Multicentric Castleman's Disease
Known additional malignancy progressing or requiring treatment within past 3 years
Active autoimmune disease requiring systemic treatment in past 2 years (hormonal supplementation allowed)
History or current pneumonitis/interstitial lung disease requiring steroids
Active infection requiring systemic therapy except those allowed by protocol
History of stem cell or solid organ transplant
Incomplete recovery or ongoing complications from major surgery

Research Team

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