Afatinib in Lung Cancer With EGFR Mutation From Circulating Tumor DNA

NCT02629523 | Completed Phase 2

• 1 other identifier: 1200.271
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lung Neoplasms; EGFR Gene Mutation

Outcome Measures

Primary Outcomes (1)

• Efficacy evaluation RECIST v1.1

  Efficacy evaluation RECIST v1.1

  2 months

Secondary Outcomes (1)

• Progression Free Survival

  2 years

Study Arms (1)

Afatinib

EXPERIMENTAL

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

Drug: Afatinib

Interventions

Afatinib DRUG

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

Also known as: Giotrif

Afatinib

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stage IIIB or IV lung cancer diagnosed radiologically with or without pathologic diagnosis
• Age\> 18 year-old
• ECOG performance status 0\~2.
• 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.
• Male patients should be willing to use barrier contraception.
• Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses
• Adequate organ function, defined as all of the following:
• Absolute neutrophil count (ANC) \>=1500/mm3
• Platelet count \>= 75,000 /mm3

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chonnam National University Hospital: lead

Study Sites (1)

Chonnam National University Hwasun Hospital

Hwasun, Jeollanam-do, 58128, South Korea

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Afatinib

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Amides; Organic Chemicals; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Young-Chul Kim, MD, PhD

  Chonnam National University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 10, 2015
• First Posted: December 14, 2015
• Study Start: June 1, 2016
• Primary Completion: December 31, 2018
• Study Completion: May 11, 2020
• Last Updated: August 3, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)