Clinical Trials List
Protocol NumberDS1062-A-U202
NCT Number(ClinicalTrials.gov Identfier)NCT04484142
Active
2020-10-15 - 2026-12-31
Phase II
Recruiting4
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 2, Multicenter, Randomized Study of DS-1062a in Advanced or Metastatic Non-Small Cell Lung Cancer with Actionable Genomic Alterations and Previously Treated with Kinase Inhibitor Therapy and Platinum-based Chemotherapy with or without Prior Immunotherapy
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Trial Applicant
Syneos Health
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Sponsor
-
Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- Wen-Pin Su Division of Hematology & Oncology
- Po-Lan Su Division of General Internal Medicine
- Wu-Chou Su Division of Hematology & Oncology
- Chien-Chung Lin Division of General Internal Medicine
- Yu-Min Yeh Division of Hematology & Oncology
- Shang-Yin Wu Division of Hematology & Oncology
- Jui-Hung Tsai Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chi-Lu Chiang Division of Thoracic Medicine
- 張毓帆 Division of Ophthalmology
- 趙恒勝 Division of Thoracic Medicine
- Chao-Hua Chiu Division of Thoracic Medicine
- Hsu-ching Huang Division of Thoracic Medicine
- 蕭慈慧 Division of Thoracic Medicine
- Heng-Sheng Chao Division of Thoracic Medicine
- Yung-Hung Luo Division of Thoracic Medicine
- 郭懿萱 Division of Ophthalmology
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 徐偉勛 Division of Hematology & Oncology
- CHAO-CHI HO CHAO-CHI HO Division of General Internal Medicine
- 楊景堯 Division of General Internal Medicine
- YEN-TING LIN Division of General Internal Medicine
- 廖斌志 Division of Hematology & Oncology
- 陳冠宇 Division of General Internal Medicine
- 蔡子修 Division of General Internal Medicine
- 魏以宣 Division of Ophthalmology
- Chia-Chi Lin 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
- Jih-Hsiang Lee Division of Hematology & Oncology
- JIN-YUAN SHIH Division of General Internal Medicine
- 許嘉林 Division of General Internal Medicine
- 林昭文 Division of Ophthalmology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Non-Small Cell Lung Cancer
Objectives
This is a study of the efficacy, pharmacokinetics, and safety of DS-1062a in participants with advanced or metastatic non-small cell lung cancer (NSCLC) with known actionable genomic alterations.
Test Drug
DS-1062a
Active Ingredient
DS-1062a
Dosage Form
Lyophilized powder for Injection
Dosage
100 mg
Endpoints
Primary Outcome Measures :
Objective Response Rate (ORR) As Assessed by Blind Independent Central Review Per RECIST v1.1 Following DS-1062a Intravenous Infusion [ Time Frame: From baseline until disease progression, death, or other protocol defined reason, up to approximately 23 months ]
ORR is defined as the proportion of participants with a best overall response of confirmed complete response (CR) or confirmed partial response (PR). CR is defined as a disappearance of all target lesions and PR is defined as at least a 30% decrease in the sum of diameters of target lesions.
Secondary Outcome Measures :
Duration of Response (DOR) As Assessed by Blinded Independent Central Review and by Investigator Per RECIST v1.1 Following DS-1062a Intravenous Infusion [ Time Frame: From baseline until disease progression, death, or other protocol defined reason, up to approximately 23 months ]
DOR is defined as the time from the date of the first documentation of response (confirmed CR or confirmed PR) to the date of the first documentation of PD or death due to any cause, whichever occurs first.
Progression-free Survival (PFS) As Assessed by Blinded Independent Central Review and by Investigator Per RECIST v1.1 Following DS-1062a Intravenous (IV) Infusion [ Time Frame: From baseline until disease progression, death, or other protocol defined reason, up to approximately 23 months ]
PFS is defined as the time from the start of study treatment to the earlier of the dates of the first documentation of progressive disease or death due to any cause.
Overall Survival (OS) Following DS-1062a Intravenous Infusion [ Time Frame: From baseline until death due to any cause, up to approximately 23 months ]
OS is defined as the time from the start of study treatment to the date of death due to any cause.
Percentage of Participants Who Reported Treatment-emergent Adverse Events Following DS-1062a Intravenous Infusion in Participants with Advanced or Metastatic NSCLC with Actionable Genomic Alterations [ Time Frame: From baseline up to approximately 23 months post treatment ]
Reported treatment-emergent adverse events, serious adverse events, adverse events of interest, and those considered related to the study drug or study procedures, or that associated DS-1062a reduction, interruption, or discontinuation.
Pharmacokinetic Parameter Maximum Concentration (Cmax) of DS-1062a, Total Anti-TROP2 Antibody, and MAAA-1181a [ Time Frame: Cycle 1, Day 1: predose (within 8 hours [h] of infusion), 30 minutes (min), 3 h, 5 h, 7 h postdose; Cycle 1, Day 2, Day 4, Day 8, and Day 15 postdose; Cycle 2 and Cycle 3, Day 1 predose (within 8 h) and postdose (within 1 h) (each cycle is 21 days) ]
Pharmacokinetic Parameter Time to Maximum Concentration (Tmax) of DS-1062a, Total Anti-TROP2 Antibody, and MAAA-1181a [ Time Frame: Cycle 1, Day 1: predose (within 8 hours [h] of infusion), 30 minutes (min), 3 h, 5 h, 7 h postdose; Cycle 1, Day 2, Day 4, Day 8, and Day 15 postdose; Cycle 2 and Cycle 3, Day 1 predose (within 8 h) and postdose (within 1 h) (each cycle is 21 days) ]
Pharmacokinetic Parameter Area Under the Concentration-Time Curve (AUC) of DS-1062a, Total Anti-TROP2 Antibody, and MAAA-1181a [ Time Frame: Cycle 1, Day 1: predose (within 8 hours [h] of infusion), 30 minutes (min), 3 h, 5 h, 7 h postdose; Cycle 1, Day 2, Day 4, Day 8, and Day 15 postdose; Cycle 2 and Cycle 3, Day 1 predose (within 8 h) and postdose (within 1 h) (each cycle is 21 days) ]
Objective Response Rate (ORR) As Assessed by Blind Independent Central Review Per RECIST v1.1 Following DS-1062a Intravenous Infusion [ Time Frame: From baseline until disease progression, death, or other protocol defined reason, up to approximately 23 months ]
ORR is defined as the proportion of participants with a best overall response of confirmed complete response (CR) or confirmed partial response (PR). CR is defined as a disappearance of all target lesions and PR is defined as at least a 30% decrease in the sum of diameters of target lesions.
Secondary Outcome Measures :
Duration of Response (DOR) As Assessed by Blinded Independent Central Review and by Investigator Per RECIST v1.1 Following DS-1062a Intravenous Infusion [ Time Frame: From baseline until disease progression, death, or other protocol defined reason, up to approximately 23 months ]
DOR is defined as the time from the date of the first documentation of response (confirmed CR or confirmed PR) to the date of the first documentation of PD or death due to any cause, whichever occurs first.
Progression-free Survival (PFS) As Assessed by Blinded Independent Central Review and by Investigator Per RECIST v1.1 Following DS-1062a Intravenous (IV) Infusion [ Time Frame: From baseline until disease progression, death, or other protocol defined reason, up to approximately 23 months ]
PFS is defined as the time from the start of study treatment to the earlier of the dates of the first documentation of progressive disease or death due to any cause.
Overall Survival (OS) Following DS-1062a Intravenous Infusion [ Time Frame: From baseline until death due to any cause, up to approximately 23 months ]
OS is defined as the time from the start of study treatment to the date of death due to any cause.
Percentage of Participants Who Reported Treatment-emergent Adverse Events Following DS-1062a Intravenous Infusion in Participants with Advanced or Metastatic NSCLC with Actionable Genomic Alterations [ Time Frame: From baseline up to approximately 23 months post treatment ]
Reported treatment-emergent adverse events, serious adverse events, adverse events of interest, and those considered related to the study drug or study procedures, or that associated DS-1062a reduction, interruption, or discontinuation.
Pharmacokinetic Parameter Maximum Concentration (Cmax) of DS-1062a, Total Anti-TROP2 Antibody, and MAAA-1181a [ Time Frame: Cycle 1, Day 1: predose (within 8 hours [h] of infusion), 30 minutes (min), 3 h, 5 h, 7 h postdose; Cycle 1, Day 2, Day 4, Day 8, and Day 15 postdose; Cycle 2 and Cycle 3, Day 1 predose (within 8 h) and postdose (within 1 h) (each cycle is 21 days) ]
Pharmacokinetic Parameter Time to Maximum Concentration (Tmax) of DS-1062a, Total Anti-TROP2 Antibody, and MAAA-1181a [ Time Frame: Cycle 1, Day 1: predose (within 8 hours [h] of infusion), 30 minutes (min), 3 h, 5 h, 7 h postdose; Cycle 1, Day 2, Day 4, Day 8, and Day 15 postdose; Cycle 2 and Cycle 3, Day 1 predose (within 8 h) and postdose (within 1 h) (each cycle is 21 days) ]
Pharmacokinetic Parameter Area Under the Concentration-Time Curve (AUC) of DS-1062a, Total Anti-TROP2 Antibody, and MAAA-1181a [ Time Frame: Cycle 1, Day 1: predose (within 8 hours [h] of infusion), 30 minutes (min), 3 h, 5 h, 7 h postdose; Cycle 1, Day 2, Day 4, Day 8, and Day 15 postdose; Cycle 2 and Cycle 3, Day 1 predose (within 8 h) and postdose (within 1 h) (each cycle is 21 days) ]
Inclution Criteria
Inclusion Criteria:
Participants eligible for inclusion in the study must meet all inclusion criteria for this 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)
Has pathologically documented NSCLC that:
Has stage IIIB or stage IV NSCLC disease at the time of enrollment (based on the American Joint Committee on Cancer, Eighth Edition).
Has one or more of the following documented activating genomic alterations: EGFR, ALK, ROS1, NTRK, BRAF, MET exon 14 skipping, or RET.
Overexpression of any of the above, in the absence of activating mutations, is NOT sufficient for enrollment
Participants with EGFR genomic alterations should be evaluated for the presence of EGFR T790M mutation after relapse/progression on/after the most recent anti-EGFR TKI, unless already known to carry this mutation. Participants with EGFR mutations (regardless of T790M status) should comprise no less than 40% and no more than 50% of participants by the conclusion of study enrollment.
Has documentation of radiographic disease progression while on or after receiving the most recent treatment regimen for advanced or metastatic NSCLC.
Participant must meet at least the following for advanced or metastatic NSCLC:
Has progressed on or after at least one kinase inhibitor as specified in the study protocol
Has progressed on or after at least 1 regimen of platinum-based chemotherapy
Up to 4 prior lines of therapy are allowed to be eligible for this study
Willing and able to undergo a mandatory pre-treatment tumor biopsy
Measurable disease based on local imaging assessment using RECIST v1.1.
Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 - 1 at screening.
Participants eligible for inclusion in the study must meet all inclusion criteria for this 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)
Has pathologically documented NSCLC that:
Has stage IIIB or stage IV NSCLC disease at the time of enrollment (based on the American Joint Committee on Cancer, Eighth Edition).
Has one or more of the following documented activating genomic alterations: EGFR, ALK, ROS1, NTRK, BRAF, MET exon 14 skipping, or RET.
Overexpression of any of the above, in the absence of activating mutations, is NOT sufficient for enrollment
Participants with EGFR genomic alterations should be evaluated for the presence of EGFR T790M mutation after relapse/progression on/after the most recent anti-EGFR TKI, unless already known to carry this mutation. Participants with EGFR mutations (regardless of T790M status) should comprise no less than 40% and no more than 50% of participants by the conclusion of study enrollment.
Has documentation of radiographic disease progression while on or after receiving the most recent treatment regimen for advanced or metastatic NSCLC.
Participant must meet at least the following for advanced or metastatic NSCLC:
Has progressed on or after at least one kinase inhibitor as specified in the study protocol
Has progressed on or after at least 1 regimen of platinum-based chemotherapy
Up to 4 prior lines of therapy are allowed to be eligible for this study
Willing and able to undergo a mandatory pre-treatment tumor biopsy
Measurable disease based on local imaging assessment using RECIST v1.1.
Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 - 1 at screening.
Exclusion Criteria
Exclusion Criteria:
Participants meeting any exclusion criteria for this study will be excluded from this study.
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.
Has leptomeningeal carcinomatosis.
Has prior treatment with:
Any agent including antibody drug conjugate (ADC) containing a chemotherapeutic agent targeting topoisomerase I.
TROP2-targeted therapy.
Uncontrolled or significant cardiovascular disease:
History of myocardial infarction within 6 months prior to Cycle 1 Day 1.
History of uncontrolled angina pectoris within 6 months prior to Cycle 1 Day 1.
Symptomatic 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 of Cycle 1 Day 1) in order to be eligible.
History of serious cardiac arrhythmia requiring treatment.
LVEF <50% or institutional lower limit of normal by ECHO or MUGA scan.
Uncontrolled hypertension (resting systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg).
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
Clinically significant corneal disease.
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.
Participants meeting any exclusion criteria for this study will be excluded from this study.
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.
Has leptomeningeal carcinomatosis.
Has prior treatment with:
Any agent including antibody drug conjugate (ADC) containing a chemotherapeutic agent targeting topoisomerase I.
TROP2-targeted therapy.
Uncontrolled or significant cardiovascular disease:
History of myocardial infarction within 6 months prior to Cycle 1 Day 1.
History of uncontrolled angina pectoris within 6 months prior to Cycle 1 Day 1.
Symptomatic 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 of Cycle 1 Day 1) in order to be eligible.
History of serious cardiac arrhythmia requiring treatment.
LVEF <50% or institutional lower limit of normal by ECHO or MUGA scan.
Uncontrolled hypertension (resting systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg).
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
Clinically significant corneal disease.
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.
The Estimated Number of Participants
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Taiwan
25 participants
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Global
150 participants
