Description:
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.
Completed
Phase 2
| Drug | Synonyms | Arms |
|---|---|---|
| Afatinib | Giotrif | Afatinib |
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.
| Name | Type | Description | Interventions |
|---|---|---|---|
| Afatinib | Experimental | Treatment efficacy of afatinib will be assessed in patients with lung cancer harboring EGFR mutations which were detected from circulating tumor DNA. |
|
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.
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 19 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
| Measure: | Efficacy evaluation RECIST v1.1 |
| Time Frame: | 2 months |
| Safety Issue: | |
| Description: | Efficacy evaluation RECIST v1.1 |
| Measure: | Progression Free Survival |
| Time Frame: | 2 years |
| Safety Issue: | |
| Description: |
| Phase: | Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Completed |
| Lead Sponsor: | Chonnam National University Hospital |
August 3, 2021