The Research Plan of Taiwan Precision Medicine

April 6, 2026 updated by: National Health Research Institutes, Taiwan

The Research Plan of Taiwan Precision Medicine: Lung Cancer

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Development of an integrated database of genetic background from treatment-naïve and TKI-refractory populations, clinical information, and therapeutic outcomes in advanced NSCLC.

  1. To enroll 550 patients who fit the criteria of this study in the enrolled period.
  2. To perform large-scale NGS analysis for specific populations, to create a map containing important genetic characteristics to help understand the mechanisms of drug resistance, and to find novel treatment strategies.
  3. To collect tumor sample for NGS testing
  4. To record previous therapeutic agents and accompanying treatment response and adverse events

Study Type

Observational

Enrollment (Estimated)

550

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
      • Chiayi City, Taiwan
        • Recruiting
        • Chang Gung Medical Foundation
        • Contact:
          • Yu-Ching Lin, MD
      • Dalin, Taiwan
        • Recruiting
        • Dalin Tzu Chi Hospital
        • Contact:
          • Chun-Liang Lai
      • Kaohsiung City, Taiwan
        • Recruiting
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
        • Contact:
          • Chong, PhD
      • Kaohsiung City, Taiwan
        • Recruiting
        • Chang Gung Medical Foundation
        • Contact:
          • Chin-Chou Wang, PhD
      • Taichung, Taiwan
        • Recruiting
        • China Medical University Hospital
        • Contact:
          • Te-Chun Hsia, MD
      • Taichung, Taiwan
        • Recruiting
        • Taichung Veterans General Hospital
        • Contact:
          • Tsung-Ying Yang, PhD
      • Taichung, Taiwan
        • Recruiting
        • Chung Shan Medical University Hospital
        • Contact:
          • Gee-Chen Chang, PhD
      • Tainan, Taiwan
        • Recruiting
        • National Cheng Kung University Hospital
        • Contact:
          • Wu-Chou Su, PhD
      • Taipei, Taiwan
        • Recruiting
        • Taipei Veterans General Hospital
        • Contact:
          • Yung-Hung Luo, PhD
      • Taipei, Taiwan
        • Recruiting
        • National Taiwan University Hospital
        • Contact:
          • Chih-Hsin Yang, PhD
      • Taipei, Taiwan
        • Recruiting
        • Tri-Service General Hospital
        • Contact:
          • Chih-Hsin U Yang
      • Taipei, Taiwan
        • Recruiting
        • Taipei Medical University-Shuang Ho Hospital
        • Contact:
          • Kang-Yun Lee, MD
      • Taoyuan District, Taiwan
        • Recruiting
        • TaoYuan General Hospital
        • Contact:
          • Shih-Wei Lee, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

  1. For patients with advanced EGFR/ALK (-) tumors, treatment-naïve or failure to ≤ two lines of systemic treatment.
  2. For patients with advanced EGFR/ALK (+) tumors, failure to ≤ two lines of systemic treatment, such as tyrosine kinase inhibitors.
  3. patients with advanced EGFR exon 20 insertion/mutation (excluding T790M mutation) adenocarcinoma, failure to ≤ four lines of systemic treatment, including tyrosine kinase inhibitor is allowed.

Description

Inclusion Criteria

  1. Ages 20 and above.
  2. Pathological reports showed adenocarcinoma, squamous cell carcinoma, large cell carcinoma, adenosquamous carcinoma, and sacromatoid carcinoma.
  3. For patients with squamous cell carcinoma, only never smokers and light smokers (less than 10 cigarettes per day) are indicated.
  4. For patients with advanced EGFR (-) and ALK (-) adenocarcinoma or other histological types regardless of EGFR/ALK status, treatment-naïve or failure to ≤ two lines of systemic treatment is allowed.
  5. For patients with advanced EGFR (+) or ALK (+) adenocarcinoma, failure to ≤ two lines of systemic treatment, including tyrosine kinase inhibitor is allowed.
  6. For patients with advanced EGFR exon 20 insertion/mutation (excluding T790M mutation) adenocarcinoma, failure to ≤ four lines of systemic treatment, including tyrosine kinase inhibitor is allowed.
  7. Reacquisition of tumor tissue after the failure of previous systemic treatment
  8. Willingness to provide the residual biopsy/operative slides.
  9. Life expectancy more than 3 months.
  10. Patients fully understand the protocol with the willingness to have regular follow-up.
  11. For patients with advanced EGFR exon 20 insertion/mutation (excluding T790M mutation) adenocarcinoma: if the patient had died before 2022/07/31, the waiver of Informed Consent Form(s) is allowed under the permission of Independent Ethics Committee/Institutional Review Board (IEC/IRB). Exclusion Criteria

1.Inability to cooperate by providing a complete medical history. 2.No available tumor tissues for genetic testing. 3.Undesirable compliance.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To perform large-scale NGS analysis for specific populations, create a map containing important genetic characteristics to help understand the mechanisms of drug resistance, and find novel treatment strategies.
Time Frame: 2021/05~2030/12
Development of an integrated database of genetic background from treatment-naïve and TKI-refractory populations, clinical information, and therapeutic outcomes in advanced NSCLC.
2021/05~2030/12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Health Research Institutes, Taiwan

Investigators

  • Principal Investigator: Nai-Jung Chiang, National Health Research Institutes, Taiwan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 23, 2021

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

April 15, 2021

First Submitted That Met QC Criteria

April 15, 2021

First Posted (Actual)

April 19, 2021

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

April 6, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T1521

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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