EGFR Mutations on ctDNA in Patients With Advanced NSCLC

NCT02623257 | Completed DMC

• 1 other identifier: 20154701
• Study Type: observational
• Target: 1,055
• Locations: 1 country
• Sites: 1

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

Keywords

Non-small Cell Lung Cancer; circulating tumor DNA; amplification refractory mutation system

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with EGFR mutation detected by amplification refractory mutation system (ARMS) assay

  The investigators will describe the proportion of EGFR mutation on ctDNA detected by ARMS assay in patients with non-small cell lung cancer (NSCLC)

  up to 2 years

Secondary Outcomes (3)

• Distribution of EGFR mutation by ARMS assays among the different Clinical characteristics

  up to 2 years

• Proportion of treatment-naive patients with EGFR mutation detected by amplification refractory mutation system (ARMS) assay

  up to 2 years

• Proportion of patients after first-line chemotherapy failure with EGFR mutation detected by amplification refractory mutation system (ARMS) assay

  up to 2 years

Interventions

mutation detection OTHER

ARMS OTHER

ctDNA analysis GENETIC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Non-small cell lung cancer (NSCLC)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• First People's Hospital of Hangzhou: lead

Study Sites (1)

Hangzhou First People's Hospital

Hangzhou, Zhejiang, 310006, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2015
• First Posted: December 7, 2015
• Study Start: January 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: December 1, 2017
• Last Updated: February 13, 2018

Record last verified: 2018-01

Locations

CN (1)