Afatinib in Lung Cancer With EGFR Mutation From Circulating Tumor DNA (LiquidLung-A)
Primary Purpose
Lung Neoplasms, EGFR Gene Mutation
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Afatinib
Sponsored by
About this trial
This is an interventional treatment trial for Lung Neoplasms
Eligibility Criteria
Inclusion Criteria:
- Stage IIIB or IV lung cancer diagnosed radiologically with or without pathologic diagnosis
- Age> 18 year-old
- ECOG performance status 0~2.
- 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
- Serum creatinine < 1.4 mg/dL
- AST or ALT < three times the upper limit of normal
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.
Sites / Locations
- Chonnam National University Hwasun Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Afatinib
Arm Description
Treatment efficacy of afatinib will be assessed in patients with lung cancer harboring EGFR mutations which were detected from circulating tumor DNA.
Outcomes
Primary Outcome Measures
Efficacy evaluation RECIST v1.1
Efficacy evaluation RECIST v1.1
Secondary Outcome Measures
Progression Free Survival
Full Information
NCT ID
NCT02629523
First Posted
December 10, 2015
Last Updated
August 1, 2021
Sponsor
Chonnam National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02629523
Brief Title
Afatinib in Lung Cancer With EGFR Mutation From Circulating Tumor DNA
Acronym
LiquidLung-A
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2016 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
May 11, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chonnam National University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Neoplasms, EGFR Gene Mutation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Afatinib
Arm Type
Experimental
Arm Description
Treatment efficacy of afatinib will be assessed in patients with lung cancer harboring EGFR mutations which were detected from circulating tumor DNA.
Intervention Type
Drug
Intervention Name(s)
Afatinib
Other Intervention Name(s)
Giotrif
Intervention Description
Treatment efficacy of afatinib will be assessed in patients with lung cancer harboring EGFR mutations which were detected from circulating tumor DNA.
Primary Outcome Measure Information:
Title
Efficacy evaluation RECIST v1.1
Description
Efficacy evaluation RECIST v1.1
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Progression Free Survival
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Stage IIIB or IV lung cancer diagnosed radiologically with or without pathologic diagnosis
Age> 18 year-old
ECOG performance status 0~2.
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
Serum creatinine < 1.4 mg/dL
AST or ALT < three times the upper limit of normal
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Young-Chul Kim, MD, PhD
Organizational Affiliation
Chonnam National University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Chonnam National University Hwasun Hospital
City
Hwasun
State/Province
Jeonnam
ZIP/Postal Code
58128
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Afatinib in Lung Cancer With EGFR Mutation From Circulating Tumor DNA
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