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Clinical Trials List

Protocol NumberMK-2870-009

NCT Number(ClinicalTrials.gov Identfier)NCT06305754

Active

2024-04-15 - 2033-12-31

Phase III

Not yet recruiting11

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 Randomized, Open-label, Phase 3 Study of MK-2870 vs. Platinum Doublets in Participants With EGFR-mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors

Trial Applicant

Merck Sharp & Dohme (I.A.) LLC
Sponsor
Trial scale

Multi-Regional Multi-Center
Update

2026/06/18

Investigators and Locations

Principal Investigator TSUNG -YING YANG 無

Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator James Chih-Hsin Yang 無

National Taiwan University Cancer Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 李日翔無

National Taiwan University Hospital Hsin-Chu Branch

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 高婉真無

Chi Mei Hospital, Liouying

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Chao-Hua Chiu 無

Taipei Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator James Chih-Hsin Yang 無

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 蘇健無

MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator CHIN-CHOU WANG 無

Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Chih-Hsi Kuo 無

Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 林聖皓無

CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator

Far Eastern Memorial Hospital

Co-Principal Investigator

王秉槐無
王恭仰無

Principal Investigator Chien-Chung Lin

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Condition/Disease

Non-small Cell Lung Cancer (NSCLC)

Objectives

Primary Objectives: (1) To compare progression-free survival (PFS) of MK-2870 versus platinum-based doublet chemotherapy, assessed by a blinded independent central review (BICR) according to RECIST version 1.1. (2) To compare overall survival (OS) of MK-2870 versus platinum-based doublet chemotherapy.

Test Drug

Injectable

Active Ingredient

Recombinant humanized IgG1 anti-TROP2 monoclonal antibody conjugated to KL610023

Dosage Form

270

Dosage

200 mg/vial

Endpoints

Inclution Criteria

Inclusion Criteria:

Histologically or cytologically confirmed diagnosis of advanced-stage nonsquamous non-small cell lung cancer (NSCLC).
Participants who have adverse events (AEs) due to previous anticancer therapies must have recovered to Grade ≤1 or baseline.
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.
Participants with history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable.
Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy.
Life expectancy of at least 3 months.

Exclusion Criteria

Exclusion Criteria:

Predominantly squamous cell histology NSCLC.
History of second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 3 years.
Grade ≥2 peripheral neuropathy.
History of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing.
Active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease.
Uncontrolled, or significant cardiovascular disease or cerebrovascular disease.
Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids.
Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
Received radiation therapy to the lung that is >30 Gray within 6 months of the first dose of study intervention.
Known active central nervous system metastases and/or carcinomatous meningitis.
Active infection requiring systemic therapy.
History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
Concurrent active HBV and HCV infection.
History of allogeneic tissue/solid organ transplant.
Participants who have not adequately recovered from major surgery or have ongoing surgical complications.

The Estimated Number of Participants

Taiwan

45 participants
Global

520 participants