Afatinib in Lung Cancer With EGFR Mutation From Circulating Tumor DNA

• Register: ClinicalTrials.gov
• Last refreshed on: 10 August 2021
• Main ID: NCT02629523
• Date of registration: 10/12/2015
• Prospective Registration: Yes
• Primary sponsor: Chonnam National University Hospital
• Public title: Afatinib in Lung Cancer With EGFR Mutation From Circulating Tumor DNA LiquidLung-A
• Scientific 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
• Date of first enrolment: June 1, 2016
• Target sample size: 21
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02629523
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Korea, Republic of

Contacts

• Name: Young-Chul Kim, MD, PhD
• Affiliation: Chonnam National University Hospital

Key inclusion & exclusion criteria

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.



Age minimum: 19 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

EGFR Gene Mutation

Lung Neoplasms

Intervention(s)

Drug: Afatinib

Primary Outcome(s)

Efficacy evaluation RECIST v1.1 [Time Frame: 2 months]

Secondary Outcome(s)

Progression Free Survival [Time Frame: 2 years]

Secondary ID(s)

1200.271

Source(s) of Monetary Support

Please refer to primary and secondary sponsors