Non-small Cell Lung Cancer Stage III, Non-Small-Cell Lung Cancer Metastatic
Conditions
Keywords
Non-small Cell Lung Cancer, circulating tumor DNA, amplification refractory mutation system
Brief summary
The study aims to explore the prevalence of EGFR mutations assessed with ctDNA samples in advanced NSCLC, who had received ≤ 1 prior systemic chemotherapy regimens.
Interventions
Sponsors
First People's Hospital of Hangzhou
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed stage IIIB/IV NSCLC; * Patient had received ≤ 1 prior systemic chemotherapy regimens; * Provision of blood (plasma) sample for ctDNA testing; * Patient must be able to comply with the protocol;
Exclusion criteria
* Prior received ≥2 systemic chemotherapy regimens; * As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease); * Histologically confirmed small cell lung cancer or other metastatic tumors; * Patient with no histologic or cytological diagnosis;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with EGFR mutation detected by amplification refractory mutation system (ARMS) assay | up to 2 years | The investigators will describe the proportion of EGFR mutation on ctDNA detected by ARMS assay in patients with non-small cell lung cancer (NSCLC) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Distribution of EGFR mutation by ARMS assays among the different Clinical characteristics | up to 2 years | The investigators will employ chi-square test to analyze the distribution of EGFR mutation by ARMS in NSCLC patients among the different characteristics including smoking status, gender, age, PS score, and tumor stage |
| Proportion of treatment-naive patients with EGFR mutation detected by amplification refractory mutation system (ARMS) assay | up to 2 years | The investigators will describe the proportion of EGFR mutation on ctDNA detected by ARMS assay in treatment-naive patients with non-small cell lung cancer (NSCLC) |
| Proportion of patients after first-line chemotherapy failure with EGFR mutation detected by amplification refractory mutation system (ARMS) assay | up to 2 years | The investigators will describe the proportion of EGFR mutation on ctDNA detected by ARMS assay in non-small cell lung cancer (NSCLC) patients after first-line chemotherapy failure |
Countries
China
Outcome results
None listed