Dec. 23, 2021 |
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July. 07, 2022 |
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jRCT2011210058 |
An Open-label, Randomized, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Trastuzumab Deruxtecan as First-line Treatment of Unresectable, Locally Advanced, or Metastatic NSCLC Harboring HER2 Exon 19 or 20 Mutations (DESTINY-Lung04) |
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Phase 3 Study of Trastuzumab Deruxtecan as First-line Treatment of Unresectable, Locally Advanced, or Metastatic NSCLC Harboring HER2 Exon 19 or 20 Mutations (DESTINY-Lung04) |
Inoguchi Akihiro |
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DAIICHI SANKYO Co.,Ltd. |
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1-2-58, Hiromachi, Shinagawa-ku, Tokyo |
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+81-3-6225-1111 |
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dsclinicaltrial@daiichisankyo.co.jp |
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Contact for Clinical Trial Information |
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DAIICHI SANKYO Co.,Ltd. |
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1-2-58, Hiromachi, Shinagawa-ku, Tokyo |
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+81-3-6225-1111 |
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dsclinicaltrial@daiichisankyo.co.jp |
Recruiting |
Jan. 04, 2022 |
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Jan. 07, 2022 | ||
264 | ||
Interventional |
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randomized controlled trial |
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open(masking not used) |
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active control |
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parallel assignment |
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treatment purpose |
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Participants at least 18 years of age |
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Tumors with targetable alterations to EGFR (or other targetable mutations including but not limited to ALK, if routinely tested as a targetable alteration with approved available therapy) |
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18age old over | ||
No limit | ||
Both |
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NSCLC Harboring HER2 Exon 19 or 20 Mutations |
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Arm1: T-DXd |
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Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) [ Time Frame: Until progression or death, assessed up to approximately 12 months ] |
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1. Overall Survival (OS) [ Time Frame: Until death, assessed up to approximately 28 months ] |
Daiichi Sankyo Co., Ltd. |
AstraZeneca | |
Applicable |
Hokkaido University Hospital Institutional Review Board | |
Kita14, Nishi5, Kita-Ku, Sapporo, Hokkaido | |
+81-11-706-7061 |
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tiken@med.hokudai.ac.jp | |
Approval | |
Yes |
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Plan Description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Supporting Materials: Study Protocol Statistical Analysis Plan (SAP) Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home |
NCT05048797 | |
ClinicalTrials.gov |
Austria/Belgium/Brazil/Canada /China/Denmark/France/Germany/India/Italy/Netherlands/Poland/Korea/Spain/Taiwan/Turkey/United States/Mexico/Hong Kong |