The Research Plan of Taiwan Precision Medicine: Lung Cancer

Status: Recruiting
Location: See all (13) locations...
Study Type: Observational
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Taiwan
Chang Gung Medical Foundation
RECRUITING
Chiayi City
Dalin Tzu Chi Hospital
RECRUITING
Dalin
Chang Gung Medical Foundation
RECRUITING
Kaohsiung City
Kaohsiung Medical University Chung-Ho Memorial Hospital
RECRUITING
Kaohsiung City
China Medical University Hospital
RECRUITING
Taichung
Chung Shan Medical University Hospital
RECRUITING
Taichung
Taichung Veterans General Hospital
RECRUITING
Taichung
National Cheng Kung University Hospital
RECRUITING
Tainan City
National Taiwan University Hospital
RECRUITING
Taipei
Taipei Medical University-Shuang Ho Hospital
RECRUITING
Taipei
Taipei Veterans General Hospital
RECRUITING
Taipei
Tri-Service General Hospital
RECRUITING
Taipei
Taoyuan General Hospital
RECRUITING
Taoyuan District
Contact Information
Primary
Ya-Ling Wu
yalin@nhri.edu.tw
886-3-7206166
Backup
Nai-Jung Chiang
njchiang@nhri.org.tw
886-6-7000123
Time Frame
Start Date: 2021-06-23
Estimated Completion Date: 2030-12-31
Participants
Target number of participants: 550
Related Therapeutic Areas
Sponsors
Leads: National Health Research Institutes, Taiwan

This content was sourced from clinicaltrials.gov

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