Clinical Trials List
2025-09-30 - 2033-12-31
Phase II
Recruiting6
ICD-10C34.10
Malignant neoplasm of upper lobe, unspecified bronchus or lung
ICD-10C34.11
Malignant neoplasm of upper lobe, right bronchus or lung
ICD-10C34.12
Malignant neoplasm of upper lobe, left bronchus or lung
ICD-10C7A.090
Malignant carcinoid tumor of the bronchus and lung
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9162.3
Malignant neoplasm of upper lobe, bronchus or lung
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of V940 in Combination With Pembrolizumab and Chemotherapy as First-Line Treatment for Participants With Metastatic Squamous NSCLC (INTerpath-013)
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Trial Applicant
Merck Sharp & Dohme (I.A.) LLC
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2026/08/18
Investigators and Locations
Co-Principal Investigator
- 吳尚俊 無
- YEN-TING LIN 無
- Chia-Chi Lin 無
- JIN-YUAN SHIH 無
- 黃信端 無
- 黃得瑞 無
- 廖斌志 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Yuh-Min Chen 無
- Chi-Lu Chiang 無
- Chia-I Shen 無
- 廖映庭 無
- 趙恒勝 無
- Yung-Hung Luo 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chih-Liang Wang 無
- Jia-Shiuan Ju 無
- 吳教恩 無
- Shih-Hong Li 無
- 枋岳甫 無
- 林定佑 無
- 邱立忠 無
- 柯皓文 無
- Ping-Chih Hsu 無
- Chih-Hsi Kuo 無
- Chih-Hung Chen 無
- 黃世緯 無
- 黃宗楨 無
- Chien-Ying Liu 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chia-Hsiang Li 無
- Yu-Chao Lin 無
- Chih-Yen Tu 無
- 陳鴻仁 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
注射劑
Active Ingredient
Pembrolizumab
Dosage Form
270
Dosage
25 mg/mL
Endpoints
2.OS，定義為從隨機分配至因任何原因死亡的時間
Inclution Criteria
Inclusion Criteria include, but are not limited to:
Has a histologically or cytologically confirmed diagnosis of squamous non-small cell lung cancer (NSCLC) (Stage IV: M1a, M1b, M1c1, M1c2, AJCC Staging Manual, Version 9). NOTE: Mixed tumors will be characterized by the predominant cell type; however, small cell elements are not permitted.
Has measurable disease per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by the local site investigator/radiology
Has provided a tissue sample that is collected either at the time of or after the diagnosis of metastatic disease AND is from a site not previously irradiated
Adverse events (AEs) due to previous anticancer therapies must have recovered to ≤Grade 1. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy are eligible
Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
Hepatitis B surface antigen (HBsAg) positive participants 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. NOTE: Participants must have completed curative antiviral therapy at least 4 weeks prior to randomization
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization
Has a life expectancy of at least 3 months
Has adequate organ function
Exclusion Criteria
Exclusion Criteria include, but are not limited to:
Is HIV-infected with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
Has received prior treatment with a cancer vaccine, including another personalized cancer vaccine (PCV)
Has received prior systemic anticancer therapy for their metastatic NSCLC
Has received prior therapy with an anti-programmed cell death 1 protein (anti-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), or anti-programmed cell death ligand 2 (anti-PD-L2) agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor. NOTE: Prior treatment with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent in the neoadjuvant or adjuvant setting for nonmetastatic NSCLC is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC
Has received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids
Has received radiation therapy to the lung that is >30 gray within 6 months of start of study intervention
Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed
Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention
Has known additional malignancy that is progressing or has required active treatment within the past 3 years
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
Has severe hypersensitivity (≥Grade 3) to V940, pembrolizumab, or any of the protocol allowed chemotherapy agents and/or any of their excipients
Has active autoimmune disease that has required systemic treatment in the past 2 years
Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
Has active infection requiring systemic therapy
Has a history of stem cell/solid organ transplant
Has not adequately recovered from major surgery or has ongoing surgical complications
The Estimated Number of Participants
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Taiwan
30 participants
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Global
180 participants
