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Report for Clinical Trial NCT02514174

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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

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.

NCT02514174 Carcinoma, Non-Small-Cell Lung ErbB Receptors
MeSH: Carcinoma, Non-Small-Cell Lung
HPO: Non-small cell lung carcinoma

1 Interventions

Name: Afatinib

Description: afatinib starting at 30 mg daily dose

Type: 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