Gefitinib Long-term Survivor Study

A Study of Clinical and Genomic Analysis on Long-term Survivors of EGFR Mutation Positive Advanced Non-small-cell Lung Cancer Patients With Gefitinib Treatment in China

NCT02932345•AstraZeneca

View on ClinicalTrials.gov

Summary

The primary objective is to describe the genomic profile of long-term survivors, especially to find out potential genomic prognosis and/or predictive factors for gefitinib long-term efficacy as compared to rapid PD patients

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•For inclusion in the long-term survivors group, the study subjects must fulfil the following criteria at the time of screening:
•1. Provision of informed consent or EC approve informed consent waiver prior to any study specific procedures
•2. Histological or cytological confirmed locally advanced NSCLC (stage III B) or metastatic (stage IV) NSCLC, not amenable to curative surgery or radiotherapy
•3. EGFR mutation positive
•4. Patients who continuously received gefitinib for at least 3 years without evidence of PD
•5. Patients with OS ≥ 5 years from NSCLC diagnosis will be preferred
•6. Collect archival tumour tissue before gefitinib treatment (blood and re-biopsy tumour tissue are optional); tumor tissue samples requirements: 1) slices requirements: \>1 cm2, thickness 4-5 μm, ≥ 15 slices. or, whole FFPE block; 2) tumor percentage \> 20% and necrosis \< 30% by pathology QC.
•For inclusion in the rapid PD group, the study subjects must fulfil the following criteria:
•1. Provision of informed consent or EC approve informed consent waiver prior to any study specific procedures
•2. Histological or cytological confirmed locally advanced NSCLC (stage III B) or metastatic (stage IV) NSCLC, not amenable to curative surgery or radiotherapy
+3 more criteria

Exclusion Criteria

•1\. Patients in whose medical objection was recorded to use the existing data from medical practice for scientific research.

Locations (14)

Research Site

Beijing, Beijing Municipality, China

Research Site

Fuzhou, Fujian, China

Research Site

Guangzhou, Guangdong, China

Research Site

Shijiazhuang, Hebei, China

Research Site

Zhengzhou, Henan, China

Research Site

Wuhan, Hubei, China

Research Site

Nanjing, Jiangsu, China

Research Site

Changchun, Jilin, China

Research Site

Shenyang, Liaoning, China

Research Site

Xi'an, Shaanxi, China

Key Dates

Start Date

October 31, 2016

Primary Completion Date

July 4, 2017

Completion Date

July 4, 2017

Last Updated

March 24, 2022

Enrollment

ACTUAL participants

Conditions

EGFR Mutation Positive Advanced Non-small-cell Lung Cancer