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Protocol NumberMK-2870-009
Active

2024-04-15 - 2033-12-31

Phase III

Not yet recruiting11

Recruiting1

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

    Merck Sharp & Dohme LLC

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

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 Chien-Chung Lin 無
National Taiwan University Hospital

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 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 Division of Thoracic Medicine
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 張晟瑜 無
Far Eastern Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chao-Hua Chiu
Taipei Medical 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

To compare sacituzumab tirumotecan to platinum-based doublet chemotherapy with respect to PFS per RECIST 1.1 as assessed by BICR Hypothesis (H1): sacituzumab tirumotecan is superior to platinum-based doublet chemotherapy with respect to PFS per RECIST 1.1 as assessed by BICR

Test Drug

injection

Active Ingredient

Recombinant humanized IgG1 anti-TROP2 monoclonal antibody conjugated to KL610023

Dosage Form

270

Dosage

200 mg/vial

Endpoints

PFS: The time from randomization to the
first documented disease progression or
death due to any cause, whichever occurs
first

Inclution Criteria

Type of Participant and Disease Characteristics
1. Have histologically or cytologically confirmed diagnosis of advanced-stage nonsquamous
NSCLC. Advanced stage is defined as Stage IV or Stage III not eligible for curative
resection or curative chemoradiation (AJCC Version 8 or current version as applicable).
2. Have documentation of tumor activating EGFR mutation, exon 19del, L858R, G719X,
S768I, or L861Q.
3. Have investigator determined radiographic disease progression on prestudy scans that are
of diagnostic quality after treatment with an EGFR TKI therapy:
a. Participants previously treated with first- or second-generation EGFR TKI
(eg, erlotinib/afatinib/gefitinib) are required to have confirmed documented absence
of EGFR T790M mutation on a biopsy sample obtained after progression. Note:
Participants with negative EGFR T790M mutation using plasma specimens will be
required to have tissue biopsy confirmation of negative T790M mutation prior to
enrollment/confirmation of eligibility.
b. Participants with confirmed acquired T790M mutation after first- or second-
generation EGFR TKI (eg, erlotinib/afatinib/gefitinib) are required to have third-
generation TKIs, such as osimertinib, treatment failure prior to enrollment. Note:
Participants must have evidence of acquired T790M mutation (using plasma or tissue
biopsy specimens) after disease progression on first-/second-generation EGFR TKI
treatment and prior to third-generation TKI treatment, such as osimertinib.
Note: Participants who do not receive third-generation TKI treatment in the 1L setting
will be limited to ~20% of the study population.
c. Participants previously failed third-generation TKI treatment, such as osimertinib, as
1L therapy are eligible regardless of their EGFR T790M mutation status.
d. TKI treatment will be allowed to continue after progression until 5 days prior to study
randomization.

Exclusion Criteria

Medical Conditions
1. Has predominantly squamous cell histology NSCLC. Participants with mixed tumors
with small cell elements or large cell neuroendocrine carcinoma are ineligible.
2. History of a second malignancy, unless potentially curative treatment has been completed
with no evidence of malignancy for 3 years.
Note: The time requirement does not apply to participants who underwent successful
definitive resection of basal cell carcinoma of the skin, squamous cell carcinoma of the
skin, or carcinoma in situ, excluding carcinoma in situ of the bladder.
3. Has Grade ≥2 peripheral neuropathy.
4. Has history of documented severe dry eye syndrome, severe Meibomian gland disease
and/or blepharitis, or severe corneal disease that prevents/delays corneal healing.
5. Has active inflammatory bowel disease requiring immunosuppressive medication or
previous history of inflammatory bowel disease (eg, Crohn’s disease, ulcerative colitis, or
chronic diarrhea).
6. Has uncontrolled, significant cardiovascular disease or cerebrovascular disease, including
New York Heart Association Class III or IV congestive heart failure, unstable angina,
myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QTcF
interval to >480 ms, and/or other serious cardiovascular and cerebrovascular diseases
within the 6 months preceding study intervention.

The Estimated Number of Participants

  • Taiwan

    45 participants

  • Global

    520 participants

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