Lung Neoplasms Clinical Trial
— LiquidLung-AOfficial 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
NCT number | NCT02629523 |
Other study ID # | 1200.271 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | June 1, 2016 |
Est. completion date | May 11, 2020 |
Verified date | August 2021 |
Source | Chonnam National University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Treatment efficacy of afatinib will be assessed in patients with lung cancer harboring EGFR mutations which were detected from circulating tumor DNA.
Status | Completed |
Enrollment | 21 |
Est. completion date | May 11, 2020 |
Est. primary completion date | December 31, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility | 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 6. Measurable lesion by RECIST v1.1 7. 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. 8. Male patients should be willing to use barrier contraception. 9. Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses 10. 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. |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Chonnam National University Hwasun Hospital | Hwasun | Jeonnam |
Lead Sponsor | Collaborator |
---|---|
Chonnam National University Hospital |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Efficacy evaluation RECIST v1.1 | Efficacy evaluation RECIST v1.1 | 2 months | |
Secondary | Progression Free Survival | 2 years |
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