SNPMiner Trials (Home Page)
Report for Clinical Trial NCT02514174
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
Continuous treatment until progression or occurence of intolerable Adverse Event (AE) or end
of trial. The end of trial is one year after the last patient has entered the study.
Name: Afatinib
Description: afatinib starting at 30 mg daily doseType: Drug
Afatinib
Primary Outcomes
Measure: Occurrence of AEs leading to dose reduction of afatinib
Time: One year after LPE
Secondary Outcomes
Measure: Occurrence of CTCAE grade 3 or higher diarrhoea
Time: One year after LPE
Measure: Occurrence of CTCAE grade 3 or higher rash/acne+ (+ represents grouped term)
Time: One year after LPE
Measure: Occurence of CTCAE grade 3 or higher stomatitis+ (+ represents grouped term)
Time: One year after LPE
Measure: Occurence of CTCAE grade 3 or higher paronychia+ (+ represents grouped term)
Time: One year after LPE
Measure: Time to first dose reduction of afatinib caused by AE's, defined as time from the date of the first administration of afatinib to the first dose reduction of afatinib caused by AE's.
Time: One year after LPE
Purpose: Treatment
Single Group Assignment
There is one SNP
SNPs
1 L858R
A Single Arm Phase IV Study of Afatinib in Elderly Patients With Stage IV or Recurrent Non-Small Cell Lung Cancer Whose Tumors Have Epidermal Growth Factor Receptor (EGFR) Exon 19 Deletions or Exon 21(L858R) Substitution Mutations. --- L858R ---
Staging is based on American Joint Committee on Cancer (AJCC) Staging for NSCLC 7th
edition (R12-4710)
- Evidence of common EGFR mutation (Del 19 and/or L858R)
- Age >= 70 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (R01-0787)
- Further inclusion criteria apply. --- L858R ---
HPO Nodes
HPO:Non-small cell lung carcinoma
Genes 3
TP53 TP53 BAP1 hr>