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Clinical Trials List

Protocol NumberMK-1084-007
NCT Number(ClinicalTrials.gov Identfier)NCT07190248
Active

2025-09-01 - 2035-12-31

Phase III

Recruiting6

ICD-10C34.90

Malignant neoplasm of unspecified part of unspecified bronchus or lung

ICD-10C34.91

Malignant neoplasm of unspecified part of right bronchus or lung

ICD-10C34.92

Malignant neoplasm of unspecified part of left bronchus or lung

ICD-10C7A.090

Malignant carcinoid tumor of the bronchus and lung

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9162.9

Malignant neoplasm of bronchus and lung, unspecified

A Phase 3, Randomized, Open-label, Multicenter Clinical Study to Evaluate the Safety and Efficacy of MK-1084 in Combination With Subcutaneous Pembrolizumab and Berahyaluronidase Alfa (MK-3475A) Versus MK-3475A in Combination With Pemetrexed/Platinum (Carboplatin or Cisplatin) Chemotherapy as First-line Treatment of Participants With KRAS G12C-Mutant, Advanced or Metastatic Nonsquamous NSCLC (KANDLELIT-007)

  • Trial Applicant

    Merck Sharp & Dohme (I.A.) LLC

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator 楊聰明 Division of Thoracic Medicine
Chiayi Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 蔡鎮良 Division of Thoracic Medicine
Tri-Service General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator James Chih-Hsin Yang Division of Hematology & Oncology
National Taiwan University Cancer Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chien-Chung Lin
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 蘇健 Division of Thoracic Medicine
MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator kang-Yun LEE Division of Thoracic Medicine
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Non-small Cell Lung Cancer

Objectives

Primary objective: To compare progression-free survival (PFS) of MK-1084 plus MK-3475A versus MK-3475A plus platinum-based doublet chemotherapy in subjects with programmed cell death-ligand 1 (PD-L1) positive tumors and tumor proportion score (TPS) ≥1%, using blinded independent central review (BICR) criteria for response to solid tumors (RECIST) version 1.1.

Test Drug

Tablets; Subcutaneous injections

Active Ingredient

MK-1084
Humanized X PD-1_mAb (H409A11) IgG4

Dosage Form

110
220

Dosage

25 mg, 50 mg/Tablet
165 mg/mL pembrolizumab and 13.8 μg/mL (2000 U/mL) MK-5180/vial

Endpoints

PFS: The time from the randomly assigned date until the recorded worsening of the disease or death from any cause, whichever comes first.

Inclution Criteria

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

Has nonsquamous NSCLC (Stage IIIB, Stage IIIC) not eligible for curative resection or chemoradiation or Stage IV: M1a, M1b, or M1c
If human immunodeficiency virus (HIV) positive, must have well controlled HIV on antiretroviral therapy (ART)

Exclusion Criteria

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

Has diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements
Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, or chronic diarrhea)
Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
Has a gastrointestinal disorder affecting absorption
Is HIV positive and has a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
Has received prior systemic anticancer therapy for their advanced or metastatic NSCLC
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 active autoimmune disease that has required systemic treatment in the past 2 years
History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
Has active infection requiring systemic therapy except those specified by protocol
Has history of stem cell/solid organ transplant
Has not adequately recovered from major surgery or has ongoing surgical complications

The Estimated Number of Participants

  • Taiwan

    36 participants

  • Global

    675 participants

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