Study of DS-1062a Versus Docetaxel in Previously Treated Advanced or Metastatic Non-small Cell Lung Cancer With or Without Actionable Genomic Alterations (TROPION-LUNG01)
Phase 3
Active, not recruiting
NCT04656652
| Condition | Non-small Cell Lung Cancer |
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| Phase | Phase 3 |
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| Sponsor | Daiichi Sankyo |
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| Status | Active, not recruiting |
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| Enrollment | 605 participants |
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| Interventions | DS-1062a, Docetaxel |
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| Start date | Dec 21, 2020 |
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| Completion date | May 10, 2024 |
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| Results posted | Jul 23, 2025 |
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Summary
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) with or without actionable genomic alterations.
Progression-free Survival (PFS) As Assessed by Blinded Independent Central Review (BICR) Per RECIST v1.1 Following DS-1062a Versus Docetaxel
From randomization until disease progression or death (whichever occurs first), up to approximately 27 months · months
| DS-1062a 6.0 mg/kg | 4.4 months |
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| Docetaxel 75 mg/m^2 | 3.7 months |
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Overall Survival (OS) Following DS-1062a Versus Docetaxel
From randomization until date of death due to any cause, up to to approximately 38 months · months
| DS-1062a 6.0 mg/kg | 12.9 ± 11.0 months |
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| Docetaxel 75 mg/m^2 | 11.8 ± 10.1 months |
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Open in BENITIONS
View on ClinicalTrials.gov
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