Precision medicine approach for non-small-cell lung cancer in Taiwan
The Research Plan of Taiwan Precision Medicine: Lung Cancer
This study is trying to gather genetic and clinical information from patients with non-small-cell lung cancer in Taiwan to see how their unique mutations affect treatment responses and to find better treatment options.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 550 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | National Health Research Institutes, Taiwan Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 13 sites (Chiayi City and 12 other locations) |
| Trial ID | NCT04849481 on ClinicalTrials.gov |
What this trial studies
This observational study aims to develop an integrated database of genetic backgrounds and clinical information for patients with non-small-cell lung cancer (NSCLC) in Taiwan. It will enroll 550 patients, focusing on those who are treatment-naïve or have failed up to two lines of systemic treatment. The study will utilize next-generation sequencing (NGS) to analyze genetic mutations and their correlation with treatment responses, particularly in populations with specific driver mutations. Additionally, it will collect tumor samples to further understand drug resistance mechanisms and identify potential novel treatment strategies.
Who should consider this trial
Good fit: Ideal candidates include adults aged 20 and above with advanced non-small-cell lung cancer who have specific genetic profiles or have failed previous treatments.
Not a fit: Patients with early-stage non-small-cell lung cancer or those who do not meet the genetic and treatment history criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective treatment options for patients with non-small-cell lung cancer.
How similar studies have performed: Other studies have shown success in utilizing next-generation sequencing for targeted therapies in lung cancer, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Chiayi City and 12 other locations
- Chang Gung Medical Foundation — Chiayi City, Taiwan (Recruiting)
- Dalin Tzu Chi Hospital — Dalin, Taiwan (Recruiting)
- Chang Gung Medical Foundation — Kaohsiung City, Taiwan (Recruiting)
- Kaohsiung Medical University Chung-Ho Memorial Hospital — Kaohsiung City, Taiwan (Recruiting)
- China Medical University Hospital — Taichung, Taiwan (Recruiting)
- Chung Shan Medical University Hospital — Taichung, Taiwan (Recruiting)
- Taichung Veterans General Hospital — Taichung, Taiwan (Recruiting)
- National Cheng Kung University Hospital — Tainan, Taiwan (Recruiting)
- National Taiwan University Hospital — Taipei, Taiwan (Recruiting)
- Taipei Medical University-Shuang Ho Hospital — Taipei, Taiwan (Recruiting)
- Taipei Veterans General Hospital — Taipei, Taiwan (Recruiting)
- Tri-Service General Hospital — Taipei, Taiwan (Recruiting)
- Taoyuan General Hospital — Taoyuan, Taiwan (Recruiting)
Study contacts
- Principal investigator: Nai-Jung Chiang — National Health Research Institutes, Taiwan
- Study coordinator: Ya-Ling Wu
- Email: yalin@nhri.edu.tw
- Phone: 886-3-7206166
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.