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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)

Phase 3 Study of Adjuvant Intismeran With or Without MK-3475A in High-Risk Stage I NSCLC

Fujita Tomoko

MSD K.K.

KITANOMARU SQUARE,1-13-12,Kudan-kita,Chiyoda-ku,Tokyo 102-8667,Japan

msdjrct@msd.com

MSDJRCT inquiry mailbox

MSD K.K.

KITANOMARU SQUARE,1-13-12,Kudan-kita,Chiyoda-ku,Tokyo 102-8667,Japan

+81-3-6272-1957

msdjrct@msd.com

Recruiting

Sept. 01, 2026

Interventional

randomized controlled trial

open(masking not used)

placebo control

parallel assignment

treatment purpose

- 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

- 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

Both

Non-Small Cell Lung Cancer

Arm A (open-label)
- Intismeran 1 mg intramuscular (IM) every 3 weeks (q3w) for up to 9 doses
- MK-3475A 790 mg subcutaneous (SC) every 6 weeks (q6w) for up to 9 doses
Arm B (double-blind)
- Intismeran 1 mg IM q3w for up to 9 doses
Arm C (double-blind)
- Placebo IM q3w for up to 9 doses

Disease-Free Survival (Arm A and Arm C)

- Disease-Free Survival
- Distant Metastasis-Free Survival
- Overall Survival
- Adverse Event (AE) s
- Discontinuing study intervention due to an AE
- Change from baseline in global health status / quality of life, physical functioning, and role functioning

+81-22-346-0325

Aug. 10, 2026

Yes

https://engagezone.msd.com/

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