Clinical Trials List
Protocol NumberMK-3475-01A
NCT Number(ClinicalTrials.gov Identfier)NCT04165070
Active
2025-11-20 - 2035-06-30
Others
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
KEYMAKER-U01 01A Sub-Trial: A phase 1/2 umbrella trial with rolling allocation for treatment-naïve patients with stage IV non-small cell lung cancer (NSCLC) receiving the investigational drug with or without pembrolizumab chemotherapy.
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Trial Applicant
Merck Sharp & Dohme (I.A.) LLC
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Sponsor
Merck & Co., Ltd. Taiwan Branch
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Trial scale
Multi-Regional Multi-Center
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Update
2026/07/02
Investigators and Locations
Co-Principal Investigator
- 林慶雄 Division of Thoracic Medicine
- 葉金水 Division of Thoracic Medicine
- 陳正雄 Division of Thoracic Medicine
- 紀炳銓 Division of Thoracic Medicine
- 蔡偉宏 Division of Thoracic Medicine
- 施穎銘 Division of Thoracic Medicine
- 林明泰 Division of Thoracic Medicine
- 林俊維 Division of Thoracic Medicine
- 詹博強 Division of Thoracic Medicine
- 黃國揚 Division of Thoracic Medicine
- 張時榮 Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Kai-Ling Lee Division of Thoracic Medicine
- Shang-Fu Hsu Division of Thoracic Medicine
- Mei-Chuan Chen Division of Thoracic Medicine
- 高冠鈞 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
黃振洋
Co-Principal Investigator
- Wen-Cheng Chang Division of Hematology & Oncology
- 吳振德
- 黃文冠 Division of Hematology & Oncology
- 譚欣媛 Division of Ophthalmology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Non-small cell lung cancer
Objectives
Part B Primary Objectives
• To evaluate the safety and tolerability of the investigational drug combination
Secondary Objectives
• To evaluate the ORR assessed by a blinded independent central review (BICR) according to RECIST 1.1
• To evaluate the duration of response (DOR) assessed by BICR according to RECIST 1.1
• To describe the pharmacokinetic (PK) characteristics of the investigational drugs
Test Drug
MK-1022
MK-2400
MK-3475 (KEYTRUDA®)
MK-2400
MK-3475 (KEYTRUDA®)
Active Ingredient
Pembrolizumab
patritumab deruxtecan
Ifinatamab deruxtecan
patritumab deruxtecan
Ifinatamab deruxtecan
Dosage Form
Injectable
Dosage
100mg/vial
100mg/vial
100 mg/4 mL
100mg/vial
100 mg/4 mL
Endpoints
- AE (Adverse Events)
- Treatment discontinuation due to AE (Adverse Events)
- Dose-limiting toxicity (DLT)
- Treatment discontinuation due to AE (Adverse Events)
- Dose-limiting toxicity (DLT)
Inclution Criteria
Inclusion criteria include, but are not limited to, the following:
• Histologically or cytologically confirmed stage IV squamous or non-squamous non-small cell lung cancer (NSCLC).
• Non-squamous NSCLC patients who do not meet the criteria for approved targeted therapy.
• Ability to provide a stocked tumor tissue sample, collected within the past 5 years, or collected between the completion of the most recent treatment and entry into the screening period; or a fresh core or resectable section of a tumor lesion obtained within 90 days prior to the start of treatment and which has not previously received radiation therapy.
• No prior systemic therapy for metastatic NSCLC.
• Completion of all screening procedures within the 35-day screening period in Part A or the 28-day screening period in Part B.
• Histologically or cytologically confirmed stage IV squamous or non-squamous non-small cell lung cancer (NSCLC).
• Non-squamous NSCLC patients who do not meet the criteria for approved targeted therapy.
• Ability to provide a stocked tumor tissue sample, collected within the past 5 years, or collected between the completion of the most recent treatment and entry into the screening period; or a fresh core or resectable section of a tumor lesion obtained within 90 days prior to the start of treatment and which has not previously received radiation therapy.
• No prior systemic therapy for metastatic NSCLC.
• Completion of all screening procedures within the 35-day screening period in Part A or the 28-day screening period in Part B.
Exclusion Criteria
Exclusion criteria include, but are not limited to, the following:
• Diagnosis of small cell lung cancer.
• Diagnosis of immunodeficiency, or current long-term systemic steroid therapy (at doses exceeding 10 mg daily equivalent of prednisone) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
• Known history of other malignant tumors that are worsening or require aggressive treatment within the past 2 years.
• Known history of active central nervous system (CNS) metastases and/or carcinomatous meningitis.
• Current history of active autoimmune disease requiring systemic treatment within the past 2 years.
• History of (non-infectious) pneumonia requiring steroid treatment, or current pneumonia.
• Active infection requiring systemic treatment.
• Clinically significant cardiac disease, including unstable angina, an acute myocardial infarction within 6 months of day 1, or New York Heart Association (NYHA) grade 3 or 4 congestive heart failure.
• Known history of human immunodeficiency virus (HIV) infection. Patients with well-controlled HIV using antiretroviral therapy (ART) are not excluded.
• A known history of hepatitis B (HBV) or known active hepatitis C virus (HCV) infection. Patients who are HBsAg positive but have received at least 4 weeks of HBV antiretroviral therapy and whose HBV viral load is undetectable before randomization are still eligible.
• Underwent major surgery within 3 weeks prior to the first dose.
• Expected need for any other form of anti-tumor therapy during the trial.
• A history or evidence of gastrointestinal (GI) disease (e.g., inflammatory bowel disease, Crohn's disease, ulcerative colitis), or impaired liver function or other conditions that, in the trial administrator's opinion, may significantly alter the absorption or metabolism of oral medications.
• Currently receiving chemotherapy and have clinically active diverticulitis, intra-abdominal abscess, intestinal obstruction, or peritoneal cancer metastasis.
• Have moderate-grade peripheral neuropathy.
• Have received systemic cytotoxic chemotherapy or other targeted or biological therapies for metastatic disease.
• Subjects receiving pemetrexed who are unable or unwilling to take folic acid and vitamin B12 supplements are excluded.
• Subjects with a known allergy or sensitivity to carboplatin, paclitaxel, pemetrexed, or any of their excipients are excluded.
• Subjects who have received >30 grays of lung radiation within 6 months prior to the first dose of the trial treatment are excluded.
• Subjects who have received an active vaccine within 30 days prior to the first dose of the trial treatment are excluded. Any nationally approved COVID-19 vaccine (including those with emergency use authorization) that is an mRNA vaccine, adenovirus vector vaccine, or inactivated vaccine is permitted; vaccines still in the experimental stage (i.e., vaccines not yet approved or granted emergency use authorization) are not permitted.
• Subjects who have previously received any immunotherapy and discontinued treatment due to a serious or more serious immune-related adverse event (irAE).
• Received chemotherapy or biological cancer treatment within 4 weeks prior to the first dose, or whose adverse events related to cancer treatment administered more than 4 weeks prior to the first dose have not recovered to Criteria in Common Terminology for Cancer Treatment (CTCAE) Grade 1 or higher (including those who have received immunomodulatory therapy and still have residual immune-related adverse reactions).
• Currently participating in or having participated in other investigational drug trials within 4 weeks prior to the first dose, or having used investigational medical devices.
• Have a history of severe allergic reactions to monoclonal antibody therapy (including pembrolizumab) and/or its excipients.
• Have received allogeneic tissue or solid organ transplants.
• Diagnosis of small cell lung cancer.
• Diagnosis of immunodeficiency, or current long-term systemic steroid therapy (at doses exceeding 10 mg daily equivalent of prednisone) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
• Known history of other malignant tumors that are worsening or require aggressive treatment within the past 2 years.
• Known history of active central nervous system (CNS) metastases and/or carcinomatous meningitis.
• Current history of active autoimmune disease requiring systemic treatment within the past 2 years.
• History of (non-infectious) pneumonia requiring steroid treatment, or current pneumonia.
• Active infection requiring systemic treatment.
• Clinically significant cardiac disease, including unstable angina, an acute myocardial infarction within 6 months of day 1, or New York Heart Association (NYHA) grade 3 or 4 congestive heart failure.
• Known history of human immunodeficiency virus (HIV) infection. Patients with well-controlled HIV using antiretroviral therapy (ART) are not excluded.
• A known history of hepatitis B (HBV) or known active hepatitis C virus (HCV) infection. Patients who are HBsAg positive but have received at least 4 weeks of HBV antiretroviral therapy and whose HBV viral load is undetectable before randomization are still eligible.
• Underwent major surgery within 3 weeks prior to the first dose.
• Expected need for any other form of anti-tumor therapy during the trial.
• A history or evidence of gastrointestinal (GI) disease (e.g., inflammatory bowel disease, Crohn's disease, ulcerative colitis), or impaired liver function or other conditions that, in the trial administrator's opinion, may significantly alter the absorption or metabolism of oral medications.
• Currently receiving chemotherapy and have clinically active diverticulitis, intra-abdominal abscess, intestinal obstruction, or peritoneal cancer metastasis.
• Have moderate-grade peripheral neuropathy.
• Have received systemic cytotoxic chemotherapy or other targeted or biological therapies for metastatic disease.
• Subjects receiving pemetrexed who are unable or unwilling to take folic acid and vitamin B12 supplements are excluded.
• Subjects with a known allergy or sensitivity to carboplatin, paclitaxel, pemetrexed, or any of their excipients are excluded.
• Subjects who have received >30 grays of lung radiation within 6 months prior to the first dose of the trial treatment are excluded.
• Subjects who have received an active vaccine within 30 days prior to the first dose of the trial treatment are excluded. Any nationally approved COVID-19 vaccine (including those with emergency use authorization) that is an mRNA vaccine, adenovirus vector vaccine, or inactivated vaccine is permitted; vaccines still in the experimental stage (i.e., vaccines not yet approved or granted emergency use authorization) are not permitted.
• Subjects who have previously received any immunotherapy and discontinued treatment due to a serious or more serious immune-related adverse event (irAE).
• Received chemotherapy or biological cancer treatment within 4 weeks prior to the first dose, or whose adverse events related to cancer treatment administered more than 4 weeks prior to the first dose have not recovered to Criteria in Common Terminology for Cancer Treatment (CTCAE) Grade 1 or higher (including those who have received immunomodulatory therapy and still have residual immune-related adverse reactions).
• Currently participating in or having participated in other investigational drug trials within 4 weeks prior to the first dose, or having used investigational medical devices.
• Have a history of severe allergic reactions to monoclonal antibody therapy (including pembrolizumab) and/or its excipients.
• Have received allogeneic tissue or solid organ transplants.
The Estimated Number of Participants
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Taiwan
6 participants
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Global
450 participants
