Clinical Trials List
2023-12-01 - 2031-05-31
Phase III
Recruiting8
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 in Combination With Pembrolizumab Compared to Pembrolizumab Monotherapy in the First-line Treatment of Participants With Metastatic Non-small Cell Lung Cancer With PD-L1 TPS Greater than or Equal to 50%
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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
2025/08/20
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 李玫萱 無
- Ying-Ming Tsai Tsai 無
- KUAN-LI WU 無
- Chih-Jen Yang 無
- 莊政皓 無
- Inn-Wen Chong 無
- 郭家佑 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chong-Jen Yu 無
- YEN-TING LIN 無
- WEI-LI MA 無
- 楊景堯 無
- CHAO-CHI HO CHAO-CHI HO 無
- 林宗哲 無
- 徐偉勛 無
- 黃得瑞 無
- 蔡子修 無
- 吳尚俊 無
- Chia-Chi Lin 無
- 許嘉林 無
- 廖唯昱 無
- 林宗哲 無
- 李日翔 無
- 施金元 無
- 陳冠宇 無
- 廖斌志 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- YEN-TING LIN 無
- 廖斌志 無
- 林宗哲 無
- 黃得瑞 無
- Chia-Chi Lin 無
- 吳尚俊 無
- 施金元 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
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
Active Ingredient
Pembrolizumab
Dosage Form
Dosage
25 mg/mL
Endpoints
Inclution Criteria
‧ You are over 18 years old.
‧ Have non-small cell lung cancer that has spread to other parts of your body and has not been treated.
‧ Your tumor tissue must also test positive for a biomarker called programmed cell death ligand 1 (PD-L1). A biomarker is a biological characteristic. Different tumors may have different biomarkers. The trial physician will discuss this with you.
A test will be used to find out if your specimen has these characteristics. Studies have shown that this test is generally accurate, but the results are not guaranteed. It is possible that the test will show false negatives (the sample has the biomarker, but the test result shows that it does not) or false positive (the sample does not have the biomarker, but the test result shows that it does). If it is a false negative, you will not be allowed to participate in this trial, even though you may benefit from the trial treatment. If it is a false positive, you may be in the trial but may not benefit from the trial treatment. There may be reasons why you cannot take part in this trial, and the trial physician or staff will discuss these reasons with you.
Exclusion Criteria
Has Grade ≥2 peripheral neuropathy.
History of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing.
Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea).
Has uncontrolled, significant cardiovascular disease or cerebrovascular disease within the 6 months preceding study intervention.
Received prior systemic anticancer therapy for their metastatic NSCLC.
Received prior therapy with an anti-PD-1, anti-PD-L1, or 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 resectable NSCLC is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC.
Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.
Received radiation therapy to the lung that is >30 Gy within 6 months of start of study intervention.
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.
Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
Known additional malignancy that is progressing or has required active treatment within the past 3 years.
Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
Known intolerance to sacituzumab tirumotecan or pembrolizumab and/or any of their excipients; for pembrolizumab, severe hypersensitivity (≥Grade 3) is exclusionary.
Known hypersensitivity to sacituzumab tirumotecan or other biologic therapy.
Active autoimmune disease that has required systemic treatment in the past 2 years.
History of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD.
Active infection requiring systemic therapy
Concurrent active Hepatitis B and Hepatitis C virus infection.
Human immunodeficiency virus (HIV)-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
History of allogeneic tissue/solid organ transplant.
Requires treatment with a strong inhibitor or inducer of Cytochrome P450 3A4 (CYP3A4) at least 14 days before the first dose of study intervention and throughout the study.
The Estimated Number of Participants
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Taiwan
18 participants
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Global
614 participants
