Precision medicine approach for non-small-cell lung cancer in Taiwan

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.