The Research Plan of Taiwan Precision Medicine

Non-small-cell Lung Cancer Clinical Trial

Official title:

The Research Plan of Taiwan Precision Medicine: Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04849481
• Other study ID #: T1521
• Status: Recruiting
• Start date: May 6, 2021
• Est. completion date: December 31, 2030

Study information

• Verified date: April 2023
• Source: National Health Research Institutes, Taiwan
• Contact: Ya-Ling Wu
• Phone: 886-3-7206166
• Email: yalin[@]nhri.edu.tw
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 EGFR/ALK mutation after resistant to TKIs for real-time 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.

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 500 patients who fit the criteria of this study in the enrolled period. 2. 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. 3. To collect tumor sample collection for NGS testing 4. To record previous therapeutic agents and accompanying treatment response and adverse events

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

• Inclusion Criteria

1. Ages 20 and above.

2. Pathological reported 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/ALK (-) tumors, treatment-naïve or failure to = two lines of systemic treatment.

5. For patients with advanced EGFR/ALK (+) tumors, failure to = two lines of systemic treatment, such as tyrosine kinase inhibitors.

6. Reacquisition of tumor tissue after the failure of previous systemic treatment

7. Willingness to provide the residual biopsy/operative slides.

8. Life expectancy more than 3 months.

9. Patients fully understand the protocol with the willingness to have regular follow-up.

• Exclusion Criteria

1. Inability to cooperate by providing a complete medical history.

2. No available tumor tissues for genetic testing.

3. Undesirable compliance.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small-cell Lung Cancer

Locations

Country	Name	City	State
Taiwan	Chang Gung Medical Foundation	Chiayi City
Taiwan	Dalin Tzu Chi Hospital	Dalin
Taiwan	Chang Gung Medical Foundation	Kaohsiung
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung
Taiwan	China Medical University Hospital	Taichung
Taiwan	Chung Shan Medical University Hospital	Taichung
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Medical University-Shuang Ho Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei
Taiwan	Tri-Service General Hospital	Taipei
Taiwan	Taoyuan General Hospital	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
National Health Research Institutes, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Development of an integrated database of genetic background from treatment-naïve and TKI-refractory populations, clinical information, and therapeutic outcomes in advanced NSCLC.	2021/05~2028/12