EGFR Mutations on ctDNA in Patients With Advanced NSCLC

NCT ID: NCT02623257

Last Updated: 2018-02-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1055 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2017-12-31

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.

Conditions

Non-small Cell Lung Cancer Stage III; Non-Small-Cell Lung Cancer Metastatic

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

mutation detection

Intervention Type: OTHER

ARMS

Intervention Type: OTHER

ctDNA analysis

Intervention Type: GENETIC

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First People's Hospital of Hangzhou

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hangzhou First People's Hospital

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

20154701

Identifier Type: -

Identifier Source: org_study_id