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Clinical Trials List

Protocol NumberMK-2870-004

NCT Number(ClinicalTrials.gov Identfier)NCT06074588

Active

2023-11-15 - 2031-12-31

Phase III

Not yet recruiting9

Recruiting3

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 Chemotherapy (Docetaxel or Pemetrexed) in Previously Treated Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) with EGFR Mutations or Other Genomic Alterations

Trial Applicant

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

Multi-Regional Multi-Center
Update

2026/02/01

Investigators and Locations

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 Jih-Hsiang Lee 無

National Taiwan University Hospital Hsin-Chu Branch

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Chien-Wei Su 無

MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Chih-Jen Yang 無

Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 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 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 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 林聖皓無

CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 魏裕峰無

E-DA Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Chien-Chung Lin Division of General Internal Medicine

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 郭雨萱無

Chi Mei Medical Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 郭雨萱無

Chi Mei Medical Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Non-small Cell Lung Cancer (NSCLC)

Objectives

main purpose ‧ For NSCLC with EGFR mutations, progression-free survival (PFS) of MK-2870 and chemotherapy was evaluated by the Blinded Independent Central Review (BICR) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). ‧ Comparing the overall survival (OS) of MK-2870 and chemotherapy for NSCLC with EGFR mutations. secondary purpose ‧ Comparing the PFS of MK-2870 with chemotherapy, as assessed by BICR according to RECIST 1.1, for all subjects with NSCLC. ‧ Comparing OS of MK-2870 versus chemotherapy for all subjects with NSCLC. ‧ Based on RECIST 1.1, BICR compared the objective response rate (ORR) of MK-2870 and chemotherapy for NSCLC with EGFR mutations. ‧ Comparing the ORR of MK-2870 and chemotherapy based on RECIST 1.1 by BICR for all subjects with NSCLC. ‧ To evaluate the duration of response (DOR) of MK-2870 compared with chemotherapy in NSCLC with EGFR mutations and in all subjects with NSCLC. ‧ To evaluate the average change from baseline in overall health status/quality of life (QoL), dyspnea, cough, and chest pain with MK-2870 compared with chemotherapy for NSCLC with EGFR mutations and all subjects with NSCLC . ‧ Time to progression assessed as overall health status/QoL, dyspnea, cough, and chest pain for MK-2870 versus chemotherapy for NSCLC with EGFR mutations and all subjects with NSCLC. ‧ Evaluate the safety and tolerability of MK-2870.

Test Drug

MK-2870PemetrexedDocetaxel

Active Ingredient

MK-2870
Pemetrexed
Docetaxel

Dosage Form

IV infusion
IV infusion
IV infusion

Dosage

200 mg/vial
500 mg/vial
20 mg/mL

Endpoints

- Progression-free survival (PFS): The time from random assignment to the first documented disease progression or death from any cause, whichever occurs first.
- Overall survival (OS): time from random assignment to death from any cause.

Inclution Criteria

Inclusion Criteria:

Histologically- or cytologically-documented advanced (Stage III not eligible for resection or curative radiation) or metastatic non-squamous NSCLC with specific mutations.
Documentation of locally assessed radiological disease progression while on or after last treatment based on Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1.
Participants with genome mutations must have received 1 or 2 prior lines of epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI), including a third generation TKI for participants with a T790M mutation; and 1 platinum-based therapy after progression on or after EGFR TKI.
Measurable disease per RECIST 1.1 as assessed by the local site investigator.
Archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated has been provided
Participants who have 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 HBV antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to randomization.
Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy.
Have an ECOG performance status of 0 or 1 within 3 days before randomization.

Exclusion Criteria

Exclusion Criteria:

Has predominantly squamous cell histology NSCLC.
Has mixed tumor(s) with small cell elements.
Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease.
Has Grade ≥2 peripheral neuropathy.
Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing.
Has uncontrolled, significant cardiovascular disease or cerebrovascular disease.
Has an EGFR T790M mutation and has not received a third generation EGFR TKI (eg, osimertinib).
Received prior systemic anticancer therapy including investigational agents within 4 weeks or 5 half-lives (whichever is shorter) before randomization.
Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.
Completed palliative radiotherapy within 7 days of the first dose. Participants must have recovered from all radiation-related toxicities and not require corticosteroids.
Received radiation therapy to the lung that is >30 Gy within 6 months of the first dose of study intervention.
Received prior treatment with a trophoblast cell-surface antigen 2 (TROP2)-targeted antibody-drug conjugate (ADC).
Received prior treatment with a topoisomerase I-containing ADC.
Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.
Known additional malignancy that is progressing or has required active treatment within the past 3 years.
Active infection requiring systemic therapy.
History of noninfectious pneumonitis/ILD that required steroids or has current pneumonitis/ILD.
Has known active central nervous system metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are clinically stable for at least 2 weeks, and are off steroids 3 days prior to dosing with study medication.
HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
Concurrent active Hepatitis B (defined as HBsAg positive and/or detectable HBV DNA) and Hepatitis C virus (defined as anti-HCV Ab positive and detectable HCV RNA) infection.

The Estimated Number of Participants

Taiwan

35 participants
Global

556 participants