Clinical trial NCT02738593: Detection Cell Free DNA in Lung Cancer Patients
Official title: Using Next Generation Sequencing (NGS) Method to Detect Circulating Free DNA (Cf-DNA) and Explore the Resistance and Prognosic Mechanism of Third Generation Epidermal Growth Factor Receptor (EGFR) Tyrosine-kinase Inhibitor (TKI) in Advanced Non-small Cell Lung Cancer (NSCLC) Patients: a Single Center Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non-small Cell Lung Cancer
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2016-04-14
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with advanced non-small cell lung cancer (NSCLC),prepare to receive third generation of epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) treatment. Patients must harboured with positive EGFR mutation (19 exon deletion, L858R、G719X、L861Q mutation), able to provide periphereal blood and tumor tissue.

Brief summary: third generation of EGFR-TKIs is the newest target therapy for NSCLC. However, we did not known the specific mechanisms for those non-responders and patients grow resistance.Next generation sequencing is current the most sensitive and specific method to exam gene mutation, diversion etc.

By consistently detect the cf-DNA, we could possibly find out the mechanisms of response and resistance.

Detailed description: Study backgroud: third generation of epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) is the newest target therapy for non small cell lung cancer (NSCLC). Two major study published in NEJM show that the overall response rate is about 60%-70%, with a progression free survival about 10 months. However, we did not known the specific mechanisms for those non-responders and patients grow resistance.

Next generation sequencing is current the most sensitive and specific method to exam gene mutation, diversion etc. By consistently detect the cf-DNA, we could possibly find out the mechanisms of response and resistance.

Eligible patients received 3rd generation EGFR-TKIs (AZD9291 and AVITINIB) were enrolled into this study. Tumor tissue sample within 6 months, and 10ml periphereal blood samples were collected at baseline. After treatment initiation, 10ml periphereal blood would be collected at every image testing time point until disease progression. Blood samples will be draw using EDTA tube and centerfuged within 2 hours and store in -80 refrigerator.

NGS testing will cover target genes of NSCLC.

Eligibility criteria: Inclusion Criteria:

* pathologically confirmed non small cell lung cancer.
* harboured with positive EGFR mutation (19 exon deletion, L858R、G719X、L861Q mutation)
* reliable patients history data.

Exclusion Criteria:

* pathologically not confirmed non small cell lung cancer.
* multiple primary cancer.

Primary outcomes:
measure: cf-DNA change from baseline
timeFrame: baseline and every 2 months up to 36 months or first documented progression disease.
Secondary outcomes:
Other outcomes:
Locations:
city: GuangZhou
country: China
facility: Sun Yat-Sen University Cancer Center
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Li Zhang
role: PRINCIPAL_INVESTIGATOR
References: