A Phase III, Randomised, Double-blind, Multi-center Study to Assess the Efficacy and Safety of TY-9591 Tablets Versus Osimertinib as First Line Treatment in Patients With EGFR-sensitive Mutation, Locally Advanced or Metastatic Non Small Cell Lung Cancer.
Sponsor study identifier
interventional
680
1 country
2
Study Start
June 8, 2022
Actual (reported)Primary Completion
May 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
To assess the efficacy and safety of TY-9591 versus Osimertinib in patients with locally advanced or Metastatic Non Small Cell Lung Cancer.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 16, 2022
Actual (reported)May 19, 2022
Actual (reported)June 8, 2022
Actual (reported)May 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Median Progression Free Survival (PFS)
PFS is defined as time from randomization until the date of first documented disease progression or death due to any cause
approximately 18 months
Objective Response Rate (ORR)
approximately 18 months
Intracranial Overall Response Rate (iORR)
approximately 18 months
Intracranial Median Progression Free Survival (iPFS)
approximately 18 months
Duration of Response (DoR)
approximately 18 months
Disease Control Rate (DCR)
approximately 18 months
TY-9591 (160mg orally, once daily) plus placebo Osimertinib (80mg orally, once daily), in accordance with the randomization schedule.
Osimertinib (80mg orally, once daily) plus placebo TY-9591 (160mg orally, once daily), in accordance with the randomization schedule.
The dose of TY-9591 is 160 mg once daily. A cycle of treatment is defined as 21 days of once daily treatment. Number of Cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.
The dose of placebo Osimertinib is 80 mg once daily. A cycle of treatment is defined as 21 days of once daily treatment. Number of Cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.
Hunan Provincial Tumor Hospital
Changsha, Hunan, 410013, China
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 201203, China
Baohui Han, MD
Shanghai Chest Hospital
Lin Wu, MD
Hunan Cancer Hospital
First Submitted
May 16, 2022
First Posted
May 19, 2022
Study Start
June 8, 2022
Actual (reported)Primary Completion
May 2025
Estimated (date passed)The dose of Osimertinib is 80 mg once daily. A cycle of treatment is defined as 21 days of once daily treatment. Number of Cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.
The dose of placebo TY-9591 is 160 mg once daily. A cycle of treatment is defined as 21 days of once daily treatment. Number of Cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
January 30, 2024
Record last verified: 2024-01
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Source: ClinicalTrials.gov.
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