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

This trial is studying intismeran autogene combined with pembrolizumab to see if it improves disease-free survival after surgery for certain stages of non-small cell lung cancer. Researchers want to determine if adding intismeran autogene helps prevent the cancer from returning. The study is sponsored by Merck Sharp & Dohme LLC.

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

Adults aged 18 years or older who have had complete surgical removal of Stage II, IIIA, or IIIB (N2) non-small cell lung cancer and have received standard platinum chemotherapy may be eligible. Participants must have no evidence of disease before starting the study and be able to receive pembrolizumab. 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. However, personal travel expenses may vary and are not guaranteed to be covered. Participants can expect the study to cover treatments and assessments related to the trial.

Actively Recruiting

Phase 3

Age: 18Years +

All Genders

ID06077760

Phase 3 Study Comparing Intismeran Autogene Plus Pembrolizumab to Placebo Plus Pembrolizumab for Adjuvant Treatment of Resected Stage II and III Non-small Cell Lung Cancer

Led by Merck Sharp & Dohme LLC · Updated on 2026-07-31

868

Participants Needed

229

Research Sites

286 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating intismeran autogene combined with pembrolizumab compared to placebo plus pembrolizumab as an additional treatment after surgery for participants with certain stages of non-small cell lung cancer NSCLC. The study focuses on participants with margin-negative, completely resected Stage II, IIIA, or IIIB with nodal involvement NSCLC. The main question is whether the combination including intismeran autogene improves disease-free survival compared to pembrolizumab with placebo. Participants are randomly assigned to two groups. One group receives 1 mg of intismeran autogene by intramuscular injection every 3 weeks for nine doses plus 400 mg of pembrolizumab by intravenous infusion every 6 weeks for up to nine doses. The other group receives a placebo injection on the same schedule plus pembrolizumab on the same infusion schedule. Treatment continues until disease recurrence, unacceptable side effects, or approximately one year, whichever comes first. During the study, participants are monitored through regular assessments up to about 78 months for disease-free survival and up to 12 years for overall survival and other health outcomes. Quality of life questionnaires and adverse event monitoring are conducted at baseline and throughout the study. The research team tracks lung cancer-specific survival and distant metastasis-free survival, as well as changes in symptoms like coughing and chest pain. Safety is closely observed throughout treatment and follow-up periods.

CONDITIONS

Brief Title

A Study of Intismeran Autogene (V940) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Non-small Cell Lung Cancer (V940-002)

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Adults aged 18 years or older
Margin negative, completely resected non-small cell lung cancer with pathological Stage II, IIIA, or IIIB (N2) squamous or nonsquamous tumor according to AJCC Eighth Edition
No evidence of disease before randomization
Received at least one dose of adjuvant standard platinum doublet chemotherapy
No more than 24 weeks between surgery and first pembrolizumab dose
Hepatitis B positive participants must have received HBV antiviral therapy for at least 4 weeks and have undetectable viral load
Participants with history of hepatitis C virus infection must have undetectable HCV viral load at screening
HIV-infected participants must have well controlled HIV on antiretroviral therapy

You will not qualify if you...

Diagnosis of small cell lung cancer or mixed tumors with small cell elements, neuroendocrine tumor with large cell components, or sarcomatoid carcinoma
HIV-infected participants with history of Kaposi's sarcoma or Multicentric Castleman's Disease
Prior neoadjuvant therapy for current NSCLC diagnosis
Prior or planned radiotherapy for current NSCLC diagnosis
Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, or other T-cell receptor agents
Prior systemic anticancer therapy including investigational agents within 4 weeks before randomization
Live or live-attenuated vaccine within 30 days before first study dose (killed vaccines allowed)
Use of investigational agent or device within 4 weeks before study intervention
Diagnosis of immunodeficiency or receiving chronic systemic steroids exceeding 10 mg prednisone equivalent daily or other immunosuppressive therapy within 7 days before first study dose
Known progressing malignancy requiring active treatment within past 5 years
Active autoimmune disease requiring systemic treatment within past 2 years (replacement therapy allowed)
History or current pneumonitis/interstitial lung disease requiring steroids
Active infection requiring systemic therapy

Research Team

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