Actively Recruiting

Age: 20Years +
All Genders
NCT04849481

The Research Plan of Taiwan Precision Medicine

Led by National Health Research Institutes, Taiwan · Updated on 2026-04-08

550

Participants Needed

13

Research Sites

496 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

The Research Plan of Taiwan Precision Medicine

Who Can Participate

Age: 20Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 20 years or older
  • Pathologically confirmed adenocarcinoma, squamous cell carcinoma, large cell carcinoma, adenosquamous carcinoma, or sarcomatoid carcinoma
  • For squamous cell carcinoma patients, never smokers or light smokers (less than 10 cigarettes per day) only
  • Advanced EGFR negative and ALK negative adenocarcinoma or other histological types, treatment-nafve or failed up to two lines of systemic treatment
  • Advanced EGFR positive or ALK positive adenocarcinoma patients who failed up to two lines of systemic treatment including tyrosine kinase inhibitors
  • Advanced EGFR exon 20 insertion/mutation (excluding T790M mutation) adenocarcinoma patients who failed up to four lines of systemic treatment including tyrosine kinase inhibitors
  • Availability of tumor tissue re-acquisition after failure of previous systemic treatment
  • Willingness to provide residual biopsy or operative slides
  • Life expectancy of more than 3 months
  • Ability to understand the protocol and willingness for regular follow-up
  • For advanced EGFR exon 20 insertion/mutation adenocarcinoma patients who died before 2022/07/31, informed consent waiver allowed with IEC/IRB permission
Not Eligible

You will not qualify if you...

  • Inability to provide a complete medical history
  • No available tumor tissues for genetic testing
  • Poor compliance with study procedures

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 13 locations

1

Chang Gung Medical Foundation

Chiayi City, Taiwan

Actively Recruiting

2

Dalin Tzu Chi Hospital

Dalin, Taiwan

Actively Recruiting

3

Chang Gung Medical Foundation

Kaohsiung City, Taiwan

Actively Recruiting

4

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Actively Recruiting

5

China Medical University Hospital

Taichung, Taiwan

Actively Recruiting

6

Chung Shan Medical University Hospital

Taichung, Taiwan

Actively Recruiting

7

Taichung Veterans General Hospital

Taichung, Taiwan

Actively Recruiting

8

National Cheng Kung University Hospital

Tainan, Taiwan

Actively Recruiting

9

National Taiwan University Hospital

Taipei, Taiwan

Actively Recruiting

10

Taipei Medical University-Shuang Ho Hospital

Taipei, Taiwan

Actively Recruiting

11

Taipei Veterans General Hospital

Taipei, Taiwan

Actively Recruiting

12

Tri-Service General Hospital

Taipei, Taiwan

Actively Recruiting

13

Taoyuan General Hospital

Taoyuan, Taiwan

Actively Recruiting

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Research Team

Y

Ya-Ling Wu

CONTACT

N

Nai-Jung Chiang

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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