Collects tumor samples from people with advanced lung cancer to guide treatment

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with advanced non-small-cell lung cancer. It collects tumor tissue for gene testing to guide treatment.

Age

20 years and older

Sex

All sexes

Disease stage

Advanced non-small-cell lung cancer: adenocarcinoma, squamous cell, large cell, adenosquamous or sarcomatoid type. Squamous cell: only never smokers and light smokers (less than 10 cigarettes per day).

Earlier treatment

EGFR (-) and ALK (-) adenocarcinoma, or other types: no treatment yet, or failure of up to two lines of treatment. EGFR (+) or ALK (+) adenocarcinoma: failure of up to two lines, including a tyrosine kinase inhibitor. EGFR exon 20 insertion/mutation (excluding T790M): failure of up to four lines, including a tyrosine kinase inhibitor.

Biomarker or test result

EGFR and ALK status is noted: wild-type, EGFR/ALK mutation, or EGFR exon 20 insertion/mutation (excluding T790M mutation). Tumor tissue must be taken again after earlier treatment failed.

Main reasons for not taking part

• Cannot give a complete medical history
• No tumor tissue available for genetic testing
• Poor compliance
• Life expectancy of 3 months or less

The registry criteria, word for word

What the trial wants to find out

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.