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LiquidLung-A: Afatinib in Lung Cancer With EGFR Mutation From Circulating Tumor DNA

Sponsor
Chonnam National University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02629523
Collaborator
(none)
21
Enrollment
1
Location
1
Arm
47.3
Actual Duration (Months)
0.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
21 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jun 1, 2016
Actual Primary Completion Date :
Dec 31, 2018
Actual Study Completion Date :
May 11, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Afatinib

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

Drug: Afatinib
Treatment efficacy of afatinib will be assessed in patients with lung cancer harboring EGFR mutations which were detected from circulating tumor DNA.
Other Names:
  • Giotrif

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Efficacy evaluation RECIST v1.1 [2 months]

      Efficacy evaluation RECIST v1.1

    Secondary Outcome Measures

    1. Progression Free Survival [2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Stage IIIB or IV lung cancer diagnosed radiologically with or without pathologic diagnosis

    2. Age> 18 year-old

    3. ECOG performance status 0~2.

    4. Activating EGFR mutation (G719X, exon 19 deletion, L858R, L861Q) detected from circulating DNA

    5. 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

    1. Measurable lesion by RECIST v1.1

    2. 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.

    3. Male patients should be willing to use barrier contraception.

    4. Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses

    5. 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:

    1. Prior exposure to EGFR-TKI. Prior chemotherapy will be permitted.

    2. 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.

    3. 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.

    4. Known pre-existing interstitial lung disease

    5. 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)

    6. 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chonnam National University Hwasun Hospital Hwasun Jeonnam Korea, Republic of 58128

    Sponsors and Collaborators

    • Chonnam National University Hospital

    Investigators

    • Study Chair: Young-Chul Kim, MD, PhD, Chonnam National University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Young-Chul Kim, Professor, Chonnam National University Hospital
    ClinicalTrials.gov Identifier:
    NCT02629523
    Other Study ID Numbers:
    • 1200.271
    First Posted:
    Dec 14, 2015
    Last Update Posted:
    Aug 3, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Lung Neoplasms
    Afatinib

    Study Results

    No Results Posted as of Aug 3, 2021