Study of DS-1062a in Advanced or Metastatic Non-small Cell Lung Cancer With Actionable Genomic Alterations (TROPION-Lung05)
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ClinicalTrials.gov Identifier: NCT04484142 |
Recruitment Status :
Active, not recruiting
First Posted : July 23, 2020
Results First Posted : April 3, 2024
Last Update Posted : April 9, 2024
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Tracking Information | |||||||||||||||||
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First Submitted Date ICMJE | July 20, 2020 | ||||||||||||||||
First Posted Date ICMJE | July 23, 2020 | ||||||||||||||||
Results First Submitted Date ICMJE | March 8, 2024 | ||||||||||||||||
Results First Posted Date ICMJE | April 3, 2024 | ||||||||||||||||
Last Update Posted Date | April 9, 2024 | ||||||||||||||||
Actual Study Start Date ICMJE | March 30, 2021 | ||||||||||||||||
Actual Primary Completion Date | March 10, 2023 (Final data collection date for primary outcome measure) | ||||||||||||||||
Current Primary Outcome Measures ICMJE |
Percentage of Participants With Objective Response Rate (ORR) Based on Blinded Independent Central Review (BICR) [ Time Frame: From baseline until disease progression, death, or other protocol defined reason, up to approximately 24 months. ] ORR is defined as the proportion of participants with a best overall response of confirmed complete response (CR) or confirmed partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
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Original Primary Outcome Measures ICMJE |
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.
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Change History | |||||||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||
Descriptive Information | |||||||||||||||||
Brief Title ICMJE | Study of DS-1062a in Advanced or Metastatic Non-small Cell Lung Cancer With Actionable Genomic Alterations (TROPION-Lung05) | ||||||||||||||||
Official Title ICMJE | Phase 2, Single-arm, Open-label Study of DS-1062a in Advanced or Metastatic Non-small Cell Lung Cancer With Actionable Genomic Alterations and Progressed On or After Applicable Targeted Therapy and Platinum Based Chemotherapy (TROPION-Lung05) | ||||||||||||||||
Brief Summary | 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. | ||||||||||||||||
Detailed Description | This study will evaluate DS-1062a 6.0 mg/kg in participants with advanced or metastatic NSCLC with actionable genomic alterations and who have been previously been treated with 1 platinum-containing therapy and 1 or more lines of targeted therapy. The study will be divided into 3 periods: Screening Period, Treatment Period, and Follow-up Period. The primary analysis of Objective Response Rate (ORR) by blinded Independent Central Review (BICR) will be conducted after all participants either have been followed for at least 9 months after the start of study treatment or have discontinued from the study, whichever occurs first. | ||||||||||||||||
Study Type ICMJE | Interventional | ||||||||||||||||
Study Phase ICMJE | Phase 2 | ||||||||||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Non-small Cell Lung Cancer | ||||||||||||||||
Intervention ICMJE | Drug: DS-1062a
DS-1062a will be administered as an intravenous (IV) infusion once every 3 weeks
Other Name: Datopotamab Deruxtecan
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Study Arms ICMJE | Experimental: DS-1062a 6.0 mg/kg
Participants will receive 6.0 mg/kg of DS-1062a
Intervention: Drug: DS-1062a
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Publications * | Not Provided | ||||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||||
Recruitment Status ICMJE | Active, not recruiting | ||||||||||||||||
Actual Enrollment ICMJE |
137 | ||||||||||||||||
Original Estimated Enrollment ICMJE |
150 | ||||||||||||||||
Estimated Study Completion Date ICMJE | December 31, 2024 | ||||||||||||||||
Actual Primary Completion Date | March 10, 2023 (Final data collection date for primary outcome measure) | ||||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria: Participants eligible for inclusion in the study must meet all inclusion criteria for this study.
KRAS mutations in the absence of any of the genomic alterations specified above will be excluded. Overexpression of EGFR, in the absence of activating mutations, is NOT sufficient for enrollment. Participants who have not received osimertinib should be evaluated for the presence of EGFR T790M mutation after relapse/progression on/after the most recent EGFR tyrosine kinase inhibitor (TKI), unless the participant is already known to be positive with document results for this mutation or unless osimertinib is not locally approved.
Exclusion Criteria: Participants meeting any exclusion criteria for this study will be excluded from this study.
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||
Listed Location Countries ICMJE | France, Germany, Hungary, Italy, Japan, Korea, Republic of, Netherlands, Spain, Taiwan, United States | ||||||||||||||||
Removed Location Countries | |||||||||||||||||
Administrative Information | |||||||||||||||||
NCT Number ICMJE | NCT04484142 | ||||||||||||||||
Other Study ID Numbers ICMJE | DS1062-A-U202 2020-002774-27 ( EudraCT Number ) |
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Has Data Monitoring Committee | No | ||||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Daiichi Sankyo | ||||||||||||||||
Original Responsible Party | Same as current | ||||||||||||||||
Current Study Sponsor ICMJE | Daiichi Sankyo | ||||||||||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||||||||||
Collaborators ICMJE | AstraZeneca | ||||||||||||||||
Investigators ICMJE |
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PRS Account | Daiichi Sankyo | ||||||||||||||||
Verification Date | April 2024 | ||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |