The Research Plan of Taiwan Precision Medicine

Official title

The Research Plan of Taiwan Precision Medicine: Lung Cancer

Overview

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.

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 patients who fit the criteria of this study in the enrolled period. 2. To perform large-scale NGS analysis for specific populations, to create a map containing important genetic characteristics to help understand the mechanisms of drug resistance, and to find novel treatment strategies. 3. To collect tumor sample for NGS testing 4. To record previous therapeutic agents and accompanying treatment response and adverse events

Primary outcome measures

• 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. [Time frame: 2021/05~2030/12]

Eligibility criteria

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

1.Inability to cooperate by providing a complete medical history. 2.No available tumor tissues for genetic testing. 3.Undesirable compliance.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Case-only

Study locations

Taiwan · 13 centers

• Chang Gung Medical Foundation — Chiayi City
• Dalin Tzu Chi Hospital — Dalin
• Chang Gung Medical Foundation — Kaohsiung City
• Kaohsiung Medical University Chung-Ho Memorial Hospital — Kaohsiung City
• China Medical University Hospital — Taichung
• Chung Shan Medical University Hospital — Taichung
• Taichung Veterans General Hospital — Taichung
• National Cheng Kung University Hospital — Tainan
• … and 5 more centers

Publications

• Liao BC, Chiang NJ, Chang GC, Su WC, Luo YH, Chong IW, Yang TY, Lai CL, Hsia TC, Ho CL, Lee KY, Hsiao CF, Ku FC, Fang WT, Chih-Hsin Yang J. Registry of Genetic Alterations of Taiwan Non-Small Cell Lung Cancer by Comprehensive Next-Generation Sequencing: A Real-World Cohort Study-Taiwan Cooperative Oncology Group T1521. JCO Glob Oncol. 2024 Sep;10:e2400125. doi: 10.1200/GO.24.00125. Epub 2024 Sep 3 PMID 39348626

Identifiers

NCT: NCT04849481 · T1521

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗