Status:
RECRUITING
The Research Plan of Taiwan Precision Medicine
Lead Sponsor:
National Health Research Institutes, Taiwan
Conditions:
Non-small-cell Lung Cancer
Eligibility:
All Genders
20+ years
Brief Summary
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 popul...
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 pat...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Ages 20 and above.
- Pathological reports showed adenocarcinoma, squamous cell carcinoma, large cell carcinoma, adenosquamous carcinoma, and sacromatoid carcinoma.
- For patients with squamous cell carcinoma, only never smokers and light smokers (less than 10 cigarettes per day) are indicated.
- 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.
- For patients with advanced EGFR (+) or ALK (+) adenocarcinoma, failure to ≤ two lines of systemic treatment, including tyrosine kinase inhibitor is allowed.
- 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.
- Reacquisition of tumor tissue after the failure of previous systemic treatment
- Willingness to provide the residual biopsy/operative slides.
- Life expectancy more than 3 months.
- Patients fully understand the protocol with the willingness to have regular follow-up.
- 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
- Inability to cooperate by providing a complete medical history. 2.No available tumor tissues for genetic testing. 3.Undesirable compliance.
Exclusion
Key Trial Info
Start Date :
June 23 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2030
Estimated Enrollment :
550 Patients enrolled
Trial Details
Trial ID
NCT04849481
Start Date
June 23 2021
End Date
December 31 2030
Last Update
July 8 2024
Active Locations (13)
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1
Chang Gung Medical Foundation
Chiayi City, Taiwan
2
Dalin Tzu Chi Hospital
Dalin, Taiwan
3
Chang Gung Medical Foundation
Kaohsiung City, Taiwan
4
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan