SNPMiner Trials (Home Page)
Report for Clinical Trial NCT04206787
 Developed by Shray Alag, 2020-2021.
SNP Clinical Trial Gene 
      This study aims to observe the sequential strategy with afatinib as first-line treatment and
      to find the optimal treatment strategy for long-term chemotherapy-free regimens in Chinese
      patients with EGFR-mutated advanced NSCLC. Furthermore, this study can also assess the
      effectiveness and safety of afatinib as first-line treatment.
    
Name: Afatinib
Description: drug
 Type: Drug
Group Labels:  1  Patients with non-small cell lung cancer (NSCLC)  
  
Primary Outcomes 
 Measure: Time on treatment (TOT) of afatinib as firstline treatment followed by 3rd generation EGFR-TKI in the event of the T790M resistance mutation is developed in patients with EGFR mutation-positive NSCLC Time: 28 months
   
Secondary Outcomes 
 Measure: Time on treatment (TOT) with afatinib as first-line treatment followed by investigator's choice treatment in event of the T790M negative status in real-world setting Time: 28 months
 Measure: Overall Survival from the start of afatinib until the date of death Time: 50 months
 Measure: Progression-Free Survival as judged by an investigator with afatinib in first-line treatment Time: 33 months
 Measure: Objective Response Rate [OR is defined as best overall response of CR and PR] according to RECIST 1.1 Time: 33 months
 Measure: Disease Control Rate [DC is defined as best overall response of CR, PR, and SD] according to to RECIST 1.1 Time: 33 months
 Measure: Proportion of resistance mechanisms after afatinib first-line Time: 12 months
 Measure: Adverse Event(s), Serious Adverse Event (s), afatinib-related AEs (ADRs) as indicated by incidence seriousness and intensity grade according to United States (US) national cancer institute's (NCI) (CTCAE Version 5.0) Time: 50 months
 
Time Perspective: Prospective
  Other 
There is one SNP
SNPs
1 T790M 
Time on treatment (TOT) of afatinib as firstline treatment followed by 3rd generation EGFR-TKI in the event of the T790M resistance mutation is developed in patients with EGFR mutation-positive NSCLC. --- T790M --- 
Time on treatment (TOT) with afatinib as first-line treatment followed by investigator's choice treatment in event of the T790M negative status in real-world setting. --- T790M ---