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Report for Clinical Trial NCT04206787
Developed by Shray Alag, 2020.
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 ---