- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02629523
Afatinib in Lung Cancer With EGFR Mutation From Circulating Tumor DNA (LiquidLung-A)
August 1, 2021 updated by: Young-Chul Kim, Chonnam National University Hospital
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
Treatment efficacy of afatinib will be assessed in patients with lung cancer harboring EGFR mutations which were detected from circulating tumor DNA.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
21
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Jeonnam
-
Hwasun, Jeonnam, Korea, Republic of, 58128
- Chonnam National University Hwasun Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
Treatment efficacy of afatinib will be assessed in patients with lung cancer harboring EGFR mutations which were detected from circulating tumor DNA.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy evaluation RECIST v1.1
Time Frame: 2 months
|
Efficacy evaluation RECIST v1.1
|
2 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Progression Free Survival
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2016
Primary Completion (Actual)
December 31, 2018
Study Completion (Actual)
May 11, 2020
Study Registration Dates
First Submitted
December 10, 2015
First Submitted That Met QC Criteria
December 11, 2015
First Posted (Estimate)
December 14, 2015
Study Record Updates
Last Update Posted (Actual)
August 3, 2021
Last Update Submitted That Met QC Criteria
August 1, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1200.271
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Lung Neoplasms
-
UNC Lineberger Comprehensive Cancer CenterSivan Innovation Ltd.CompletedLung Cancer | Neoplasms, Lung | Pulmonary Neoplasms | Neoplasms, Pulmonary | Pulmonary Cancer | Cancer of LungUnited States
-
Baptist Health South FloridaWithdrawnLung Cancer | Lung TumorUnited States
-
Oliver JonasMassachusetts General HospitalCompletedLung Cancer | Lung TumorUnited States
-
C. R. BardCompleted
-
Portsmouth Hospitals NHS TrustCompletedLung Cancer | Interstitial Lung DiseaseUnited Kingdom
-
Azienda Sanitaria-Universitaria Integrata di UdineRecruitingLung Diseases | Lung Cancer | Lung Adenocarcinoma | Lung Transplant Rejection | Lung; Node | Lung TBItaly
-
University of UtahRecruitingLung Cancer | Lung Neoplasms/DiagnosisUnited States
-
Point TherapeuticsTerminatedCarcinoma, Non-Small-Cell Lung | Lung Cancer | Neoplasms, Lung | Neoplasms, PulmonaryUnited States
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)CompletedLung Carcinoma | Lung Neoplasm | Malignant Lung NeoplasmUnited States
-
Keimyung University Dongsan Medical CenterCompletedLung Cancer | Lung Diseases, Interstitial
Clinical Trials on Afatinib
-
Boehringer IngelheimCompleted
-
Centre Leon BerardBoehringer IngelheimCompletedHead and Neck Squamous Cell CarcinomaFrance
-
Boehringer IngelheimCompletedCarcinoma, Non-Small-Cell LungGreece
-
Boehringer IngelheimCompletedNeuroectodermal Tumors | RhabdomyosarcomaUnited States, Spain, Canada, Germany, Italy, United Kingdom, Australia, Austria, Denmark, Faroe Islands, France, Netherlands
-
Boehringer IngelheimCompleted
-
University of ChicagoNational Cancer Institute (NCI)RecruitingRecurrent Bladder Cancer | Stage III Bladder Cancer | Stage IV Bladder Cancer | Ureter Cancer | Distal Urethral Cancer | Proximal Urethral Cancer | Recurrent Urethral Cancer | Stage III Urethral Cancer | Stage IV Urethral CancerUnited States
-
Boehringer IngelheimCompleted
-
Boehringer IngelheimNo longer available
-
University College, LondonBoehringer IngelheimCompletedCarcinoma, Non-Small-Cell LungUnited Kingdom
-
Boehringer IngelheimCompletedCarcinoma, Non-Small-Cell LungKorea, Republic of