A Phase II, Open-Label, Multicentre Study to Assess the Anti-tumour Activity of Afatinib in Patients With Activating Epidermal Growth Factor Receptor Mutation in Circulating Tumor DNA

Chonnam National University Hospital1 site in 1 country21 target enrollmentJune 1, 2016

ConditionsLung Neoplasms EGFR Gene Mutation

InterventionsAfatinib

DrugsAfatinib

Overview

Phase: Phase 2
Intervention: Afatinib
Conditions: Lung Neoplasms
Sponsor: Chonnam National University Hospital
Enrollment: 21
Locations: 1
Primary Endpoint: Efficacy evaluation RECIST v1.1
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Treatment efficacy of afatinib will be assessed in patients with lung cancer harboring EGFR mutations which were detected from circulating tumor DNA.

Detailed Description

Obtaining Tumor tissue or cytology samples are not always available in some patients with lung cancer. Recently, studies showed that circulating tumor DNA can be used as a suitable substitute for mutation analysis. The sensitivity of EGFR mutation tests using circulating tumor DNA was reported in the range of 65.7% (10) to 75% (11), with high specificity and positive predictive value. In this trial, treatment efficacy of afatinib will be assessed in patients with NSCLC harboring EGFR mutations which were detected from circulating tumor DNA.

Registry

clinicaltrials.gov

Start Date

June 1, 2016

End Date

May 11, 2020

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Chonnam National University Hospital

Responsible Party

Principal Investigator

Young-Chul Kim

Professor

Chonnam National University Hospital

Eligibility Criteria

Inclusion Criteria

•Stage IIIB or IV lung cancer diagnosed radiologically with or without pathologic diagnosis
•Age\> 18 year-old
•ECOG performance status 0\~
•Activating EGFR mutation (G719X, exon 19 deletion, L858R, L861Q) detected from circulating DNA
•Any one of the following criteria should be met
•Unavailable or failed pathologic/cytologic diagnosis
•Wild type or failed EGFR testing based on tumor tissue
•No more tumor sample available for EGFR test
•Measurable lesion by RECIST v1.1
•Females should be using adequate contraceptive measures, should not be breast feeding and must have a negative pregnancy test prior to start of dosing or evidence of non-child bearing potential.

Exclusion Criteria

•Prior exposure to EGFR-TKI. Prior chemotherapy will be permitted.
•Previous or concomitant malignancies at other sites, except effectively treated non-melanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ or effectively treated malignancy that has been in remission for more than 3 years and is considered to be cured.
•Severe or unstable medical conditions such as history or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure NYHA classification of ≥ 3, unstable angina or poorly controlled arrhythmia as determined by the investigator. Myocardial infarction within 6 months prior to randomisation.
•Known pre-existing interstitial lung disease
•Any history or presence of poorly controlled gastrointestinal disorders that could affect the absorption of the study drug (e.g. Crohn's disease, ulcerative colitis, chronic diarrhoea, malabsorption)
•Active hepatitis B infection (defined as presence of HepB sAg and Hep B DNA), active hepatitis C infection (defined as presence of Hep C RNA) and/or known HIV carrier.