Clinical Trials List
Protocol NumberDS1062-A-U301
NCT Number(ClinicalTrials.gov Identfier)NCT04656652
2020-12-14 - 2025-07-28
Phase III
Recruiting8
ICD-10C34.80
Malignant neoplasm of overlapping sites of unspecified bronchus and lung
ICD-10C34.81
Malignant neoplasm of overlapping sites of right bronchus and lung
ICD-10C34.82
Malignant neoplasm of overlapping sites of left bronchus and lung
ICD-10C7A.090
Malignant carcinoid tumor of the bronchus and lung
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9162.8
Malignant neoplasm of other parts of bronchus or lung
Phase 3 Randomized Study of DS-1062a Versus Docetaxel in Previously Treated Advanced or Metastatic Non- Small Cell Lung Cancer without Actionable Genomic Alterations (TROPION-Lung01)
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Trial Applicant
Syneos Health
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Sponsor
-
Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- 徐偉勛 醫學研究部
- JIN-YUAN SHIH Division of General Internal Medicine
- 許嘉林 Division of General Internal Medicine
- YEN-TING LIN Division of General Internal Medicine
- Jih-Hsiang Lee Division of Hematology & Oncology
- WEI-LI MA Division of Hematology & Oncology
- CHAO-CHI HO CHAO-CHI HO Division of General Internal Medicine
- 楊景堯 Division of General Internal Medicine
- Chia-Chi Lin Division of Hematology & Oncology
- 林宗哲 Division of Hematology & Oncology
- 陳冠宇 Division of General Internal Medicine
- 蔡子修 Division of General Internal Medicine
- 廖斌志 Division of Hematology & Oncology
- Chong-Jen Yu Division of General Internal Medicine
- 廖唯昱 Division of General Internal Medicine
- 吳尚俊 Division of General Internal Medicine
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
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Cheng-Ta Yang 無
- Chih-Hsi Kuo 無
- 吳振徳 無
- 吳教恩 無
- Chih-Liang Wang 無
- Shih-Hong Li 無
- Chien-Ying Liu 無
- 枋岳甫 無
- Chih-Hung Chen 無
- 張境夫 無
- Chih-Hung Chen 未分科
- Ping-Chih Hsu 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 王逸熙 無
- 鍾聿修 無
- 林理涵 無
- CHIN-CHOU WANG 無
- Chia-Cheng Tseng 無
- 黃國棟 無
- Shau-Hsuan Li 無
- 趙東瀛 無
- 陳彥豪 無
- 林孟志 無
- 賴建豪 無
- 李易濰 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 賴永發 Division of Thoracic Medicine
- 李和昇 Division of Thoracic Medicine
- 吳俊廷 Division of Thoracic Medicine
- 陳俊榮 Division of Thoracic Medicine
- 邱建通 Division of Thoracic Medicine
- 陳鍾岳 Division of Thoracic Medicine
- 許棨逵 Division of Thoracic Medicine
- 周柏安 Division of Thoracic Medicine
- Ming-Shyan Huang Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Non- Small Cell Lung Cancer
Objectives
This study will evaluate the efficacy, safety, and pharmacokinetics of DS-1062a versus docetaxel in participants with previously treated advanced or metastatic non-small cell lung cancer (NSCLC) without actionable genomic alterations.
Test Drug
DS-1062a
Active Ingredient
DS-1062a
Dosage Form
Injection
Dosage
100 mg
Endpoints
1.Progression-free Survival (PFS) As Assessed by Blinded Independent Central Review (BICR) Per RECIST v1.1 Following DS-1062a Versus Docetaxel [ Time Frame: From randomization until disease progression or death (whichever occurs first), up to approximately 43 months ]
PFS is defined as the time from randomization to the earlier of the dates of the first documentation of radiographic progressive disease or death due to any cause.
2.Overall Survival (OS) Following DS-1062a Versus Docetaxel [ Time Frame: From randomization until date of death due to any cause, up to approximately 43 months ]
OS is defined as the time from randomization to the date of death due to any cause.
PFS is defined as the time from randomization to the earlier of the dates of the first documentation of radiographic progressive disease or death due to any cause.
2.Overall Survival (OS) Following DS-1062a Versus Docetaxel [ Time Frame: From randomization until date of death due to any cause, up to approximately 43 months ]
OS is defined as the time from randomization to the date of death due to any cause.
Inclution Criteria
Inclusion Criteria:
Participants eligible for inclusion in the study must meet all inclusion criteria within 28 days of randomization into the study.
Sign and date the inform consent form (ICF) prior to the start of any study specific qualification procedures.
Adults ≥18 years (if the legal age of consent is >18 years old, then follow local regulatory requirements)
Life expectancy ≥3 months
Has pathologically documented NSCLC that:
Has stage IIIB, IIIC, or stage IV NSCLC disease at the time of randomization (based on the American Joint Committee on Cancer, Eighth Edition)
Has documented negative test results for epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK)
Has no known genomic alterations in ROS proto-oncogene 1 (ROS1), neurotrophic tyrosine receptor kinase (NTRK), proto oncogene B-raf (BRAF), or other actionable driver oncogenes with approved therapies (actionable genomic alteration)
Has documentation of radiographic disease progression while on or after receiving the most recent treatment regimen for advanced or metastatic NSCLC
Participant must meet 1 of the following prior therapy requirements for advanced or metastatic NSCLC:
Received platinum-based chemotherapy in combination with α-PD-1/α-PD-L1 monoclonal antibody as the only prior line of therapy
Includes participants who received prior platinum-based chemo/radiotherapy with maintenance α-PD-1/α-PD-L1 monoclonal antibody for Stage III disease and relapsed/progressed within 6 months from the last dose of platinum-based chemotherapy
Includes participants who received prior platinum-based chemo/radiotherapy (with or without maintenance α-PD-1/α-PD-L1 monoclonal antibody) for Stage III disease and subsequently received α-PD-1/α-PD-L1 monoclonal antibody therapy (with or without platinum-based chemotherapy) for recurrent disease
Received platinum-based chemotherapy and α-PD-1/α-PD-L1 monoclonal antibody (in either order) sequentially as the only 2 prior lines of therapy
Must undergo a mandatory pre-treatment tumor biopsy procedure or, if available, a tumor biopsy that was recently collected (within 3 months of Screening) after completion of the most recent anticancer treatment regimen and of adequate size may be substituted for the mandatory pre-treatment biopsy procedure collected during Screening.
Archival tumor tissue from initial diagnosis is required, to the extent that archival tumor tissue is available
Measurable disease based on local imaging assessment using RECIST v1.1
Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 at Screening
Within 7 days before Cycle 1 Day 1, has adequate bone marrow, hepatic, and renal function
Left ventricular ejection fraction (LVEF) ≥50% by either echocardiogram (ECHO) or multigated acquisition (MUGA) scan within 28 days before Cycle 1 Day 1
Adequate blood clotting function defined as international normalized ratio/prothrombin time and either partial thromboplastin or activated partial thromboplastin time ≤1.5 × upper limit of normal (ULN)
Adequate treatment washout period before Cycle 1 Day 1
Females of childbearing potential must have a negative serum pregnancy test at screening and must be willing to use highly effective birth control from the time of enrollment up to 7 months after the last dose of DS-1062a or for at least 6 months after the last dose of docetaxel
Males must be surgically sterile or must use a condom in addition to highly effective birth control if his partners are of reproductive potential from the time of enrollment and for at least 4 months after last dose of DS-1062a or for at least 6 months after the last dose of docetaxel
Male participants must not freeze or donate sperm from the time of Screening and throughout the study period and for at least 4 months after the last dose of DS-1062a or for at least 6 months after the last dose of docetaxel
Female participants must not donate, or retrieve for their own use, ova from the time of Screening and throughout the study period and for at least 7 months after the last dose of DS-1062a and for at least 6 months after the last dose of docetaxel
Participants eligible for inclusion in the study must meet all inclusion criteria within 28 days of randomization into the study.
Sign and date the inform consent form (ICF) prior to the start of any study specific qualification procedures.
Adults ≥18 years (if the legal age of consent is >18 years old, then follow local regulatory requirements)
Life expectancy ≥3 months
Has pathologically documented NSCLC that:
Has stage IIIB, IIIC, or stage IV NSCLC disease at the time of randomization (based on the American Joint Committee on Cancer, Eighth Edition)
Has documented negative test results for epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK)
Has no known genomic alterations in ROS proto-oncogene 1 (ROS1), neurotrophic tyrosine receptor kinase (NTRK), proto oncogene B-raf (BRAF), or other actionable driver oncogenes with approved therapies (actionable genomic alteration)
Has documentation of radiographic disease progression while on or after receiving the most recent treatment regimen for advanced or metastatic NSCLC
Participant must meet 1 of the following prior therapy requirements for advanced or metastatic NSCLC:
Received platinum-based chemotherapy in combination with α-PD-1/α-PD-L1 monoclonal antibody as the only prior line of therapy
Includes participants who received prior platinum-based chemo/radiotherapy with maintenance α-PD-1/α-PD-L1 monoclonal antibody for Stage III disease and relapsed/progressed within 6 months from the last dose of platinum-based chemotherapy
Includes participants who received prior platinum-based chemo/radiotherapy (with or without maintenance α-PD-1/α-PD-L1 monoclonal antibody) for Stage III disease and subsequently received α-PD-1/α-PD-L1 monoclonal antibody therapy (with or without platinum-based chemotherapy) for recurrent disease
Received platinum-based chemotherapy and α-PD-1/α-PD-L1 monoclonal antibody (in either order) sequentially as the only 2 prior lines of therapy
Must undergo a mandatory pre-treatment tumor biopsy procedure or, if available, a tumor biopsy that was recently collected (within 3 months of Screening) after completion of the most recent anticancer treatment regimen and of adequate size may be substituted for the mandatory pre-treatment biopsy procedure collected during Screening.
Archival tumor tissue from initial diagnosis is required, to the extent that archival tumor tissue is available
Measurable disease based on local imaging assessment using RECIST v1.1
Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 at Screening
Within 7 days before Cycle 1 Day 1, has adequate bone marrow, hepatic, and renal function
Left ventricular ejection fraction (LVEF) ≥50% by either echocardiogram (ECHO) or multigated acquisition (MUGA) scan within 28 days before Cycle 1 Day 1
Adequate blood clotting function defined as international normalized ratio/prothrombin time and either partial thromboplastin or activated partial thromboplastin time ≤1.5 × upper limit of normal (ULN)
Adequate treatment washout period before Cycle 1 Day 1
Females of childbearing potential must have a negative serum pregnancy test at screening and must be willing to use highly effective birth control from the time of enrollment up to 7 months after the last dose of DS-1062a or for at least 6 months after the last dose of docetaxel
Males must be surgically sterile or must use a condom in addition to highly effective birth control if his partners are of reproductive potential from the time of enrollment and for at least 4 months after last dose of DS-1062a or for at least 6 months after the last dose of docetaxel
Male participants must not freeze or donate sperm from the time of Screening and throughout the study period and for at least 4 months after the last dose of DS-1062a or for at least 6 months after the last dose of docetaxel
Female participants must not donate, or retrieve for their own use, ova from the time of Screening and throughout the study period and for at least 7 months after the last dose of DS-1062a and for at least 6 months after the last dose of docetaxel
Exclusion Criteria
Exclusion Criteria:
Mixed small-cell lung cancer (SCLC) and NSCLC histology
Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms. Participants with clinically inactive brain metastases may be included in the study. Participants with treated brain metastases who are no longer symptomatic and who require no treatment with corticosteroids or anticonvulsants may be included in the study if they have recovered from the acute toxic effect of radiotherapy.
Has leptomeningeal carcinomatosis or metastasis
Had prior treatment with:
Any agent including antibody drug conjugate (ADC) containing a chemotherapeutic agent targeting topoisomerase I
TROP2-targeted therapy
Docetaxel as monotherapy or in combination with other agents
Had prior treatment with platinum-based chemotherapy and prior immunotherapy for Stage II NSCLC disease (eg, in the neo-adjuvant or adjuvant setting) without subsequently meeting the prior therapy requirements for Stage III or metastatic NSCLC disease
Has NSCLC disease that is eligible for definitive local therapy alone
Uncontrolled or significant cardiovascular disease, including:
Mean QT interval corrected for heart rate using Fridericia's formula >470 msec (based on the average of Screening triplicate 12-lead electrocardiogram [ECG] determinations).
History of myocardial infarction within 6 months before Cycle 1 Day 1
History of uncontrolled angina pectoris within 6 months before Cycle 1 Day 1
Congestive heart failure (CHF) (New York Heart Association Class II to IV) at Screening. Participants with a history of Class II to IV CHF prior to Screening, must have returned to Class I CHF and have LVEF ≥50% (by either an ECHO or MUGA scan within 28 days before Cycle 1 Day 1) in order to be eligible.
History of serious cardiac arrhythmia requiring treatment
LVEF <50% by ECHO or MUGA scan within 28 days before Cycle 1 Day 1
Uncontrolled hypertension (resting systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg) within 28 days before Cycle 1 Day 1
Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening
Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (ie, pulmonary emboli within 3 months of study Cycle 1 Day 1, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc.), or any autoimmune, connective tissue or inflammatory disorders with pulmonary involvement (ie, rheumatoid arthritis, Sjogren's syndrome, sarcoidosis, etc.), or prior pneumonectomy.
Significant third-space fluid retention (for example ascites or pleural effusion) and is not amenable for required repeated drainage.
Clinically significant corneal disease
Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals; suspected infections (eg, prodromal symptoms); or inability to rule out infections
Has known human immunodeficiency virus (HIV) infection that is not well controlled
Active hepatitis B and/or hepatitis C infection, such as those with serologic evidence of viral infection within 28 days of Cycle 1 Day 1
Has other primary malignancies, except adequately resected non-melanoma skin cancer, curatively treated in situ disease, or other solid tumors curatively treated, with no evidence of disease for ≥3 years.
Toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet improved to NCI-CTCAE version 5.0 Grade ≤1 or baseline
Has other primary malignancies, except adequately resected non-melanoma skin cancer, curatively treated in situ disease, or other solid tumors curatively treated, with no evidence of disease for ≥3 years
Has a history of severe hypersensitivity reactions to either the drug substances, inactive ingredients (including but not limited to polysorbate 80) of DS-1062a or docetaxel, or monoclonal antibodies
Pregnant or breastfeeding
Have substance abuse or any other medical conditions such as clinically significant cardiac or psychological conditions
Mixed small-cell lung cancer (SCLC) and NSCLC histology
Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms. Participants with clinically inactive brain metastases may be included in the study. Participants with treated brain metastases who are no longer symptomatic and who require no treatment with corticosteroids or anticonvulsants may be included in the study if they have recovered from the acute toxic effect of radiotherapy.
Has leptomeningeal carcinomatosis or metastasis
Had prior treatment with:
Any agent including antibody drug conjugate (ADC) containing a chemotherapeutic agent targeting topoisomerase I
TROP2-targeted therapy
Docetaxel as monotherapy or in combination with other agents
Had prior treatment with platinum-based chemotherapy and prior immunotherapy for Stage II NSCLC disease (eg, in the neo-adjuvant or adjuvant setting) without subsequently meeting the prior therapy requirements for Stage III or metastatic NSCLC disease
Has NSCLC disease that is eligible for definitive local therapy alone
Uncontrolled or significant cardiovascular disease, including:
Mean QT interval corrected for heart rate using Fridericia's formula >470 msec (based on the average of Screening triplicate 12-lead electrocardiogram [ECG] determinations).
History of myocardial infarction within 6 months before Cycle 1 Day 1
History of uncontrolled angina pectoris within 6 months before Cycle 1 Day 1
Congestive heart failure (CHF) (New York Heart Association Class II to IV) at Screening. Participants with a history of Class II to IV CHF prior to Screening, must have returned to Class I CHF and have LVEF ≥50% (by either an ECHO or MUGA scan within 28 days before Cycle 1 Day 1) in order to be eligible.
History of serious cardiac arrhythmia requiring treatment
LVEF <50% by ECHO or MUGA scan within 28 days before Cycle 1 Day 1
Uncontrolled hypertension (resting systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg) within 28 days before Cycle 1 Day 1
Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening
Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (ie, pulmonary emboli within 3 months of study Cycle 1 Day 1, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc.), or any autoimmune, connective tissue or inflammatory disorders with pulmonary involvement (ie, rheumatoid arthritis, Sjogren's syndrome, sarcoidosis, etc.), or prior pneumonectomy.
Significant third-space fluid retention (for example ascites or pleural effusion) and is not amenable for required repeated drainage.
Clinically significant corneal disease
Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals; suspected infections (eg, prodromal symptoms); or inability to rule out infections
Has known human immunodeficiency virus (HIV) infection that is not well controlled
Active hepatitis B and/or hepatitis C infection, such as those with serologic evidence of viral infection within 28 days of Cycle 1 Day 1
Has other primary malignancies, except adequately resected non-melanoma skin cancer, curatively treated in situ disease, or other solid tumors curatively treated, with no evidence of disease for ≥3 years.
Toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet improved to NCI-CTCAE version 5.0 Grade ≤1 or baseline
Has other primary malignancies, except adequately resected non-melanoma skin cancer, curatively treated in situ disease, or other solid tumors curatively treated, with no evidence of disease for ≥3 years
Has a history of severe hypersensitivity reactions to either the drug substances, inactive ingredients (including but not limited to polysorbate 80) of DS-1062a or docetaxel, or monoclonal antibodies
Pregnant or breastfeeding
Have substance abuse or any other medical conditions such as clinically significant cardiac or psychological conditions
The Estimated Number of Participants
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Taiwan
30 participants
-
Global
590 participants
