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The Research Plan of Taiwan Precision Medicine

StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Notable Primary completion date: Dec 31, 2025 to Dec 31, 2030v5
  2. Minor Eligibility criteria expanded, about 3 wordsv4
  3. Notable Start date: May 6, 2021 to Jun 23, 2021
    • Enrollment target: 500 to 550
    • Eligibility criteria expanded, about 80 words
    • Study description expanded, about 1 word
    v3
  4. Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Primary completion date: Dec 31, 2023 to Dec 31, 2025
    • Study sites: 9 to 13
    • Study completion date: Dec 31, 2028 to Dec 31, 2030
    • Start date changed from estimate of Apr 30, 2021 to May 6, 2021
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Non-small-cell lung cancer (NSCLC) is one of the top three most common cancers in Taiwan. Targetable driver mutations in NSCLC are more prevalent in Asian population compared to those in Western population, which offers chances to apply suitable targeted therapies worldwide. For patients who failed to the treatment of tyrosine kinase inhibitors (TKIs), the genetic mutations from next-generation sequencing (NGS) reports can serve as the reference of treatment selection. Moreover, the expression of PD-1/PD-L1 serves as a helpful indicator for the response of immune checkpoint inhibitors (ICIs). On the other hand, patients with wild-type EGFR/ALK mutations and PD-L1-negative NSCLC who received chemotherapy had relative poorer survival than those received suitable targeted therapies and ICIs. To further elucidate the underlying molecular genomic aberrations, as well as the clinical demographics and therapeutic outcomes in above subpopulations, it is necessary to have a national, multi-centers and population-focused research project to collect data completely. Tumor tissue will be collected from advanced NSCLC patients with wild-type EGFR/ALK or with EGFR/ALK mutation after resistant to TKIs for next-generation sequencing analysis in a platform of data storage and sharing. The purpose of the precision medicine project is to establish tumor molecular profiling of specific NSCLC populations in Taiwan, to facilitate patients to have corresponding potential targeted therapeutics and suitable clinical trials, and to extend the median overall survival.
Trial Details
NCT Number NCT04849481
Lead Sponsor National Health Research Institutes, Taiwan
Conditions
(from sponsor)
Non-small-cell Lung Cancer
Related terms Carcinoma, Non-Small-Cell Lung
Enrollment 550 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov