Osimertinib is an epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) that
is selective for both EGFR-TKI sensitizing and T790M resistance mutations in patients with
non-small-cell lung cancer.
The AURA 3 study (T790M-positive advanced non-small-cell lung cancer in progression after
first-line EGFR-TKI therapy, shown that the median duration of progression-free survival was
significantly longer with osimertinib than with platinum therapy plus pemetrexed (10.1 months
vs. 4.4 months p<0.001).
In addition, clinical data show that patients with mutated EGFR NSCLC receiving osimertinib
in first line, presented an objective response rate of 77 % with a disease control rate of 98
% and a median PFS was 19.3 months.
Finally, The FLAURA study randomized phase 3 study clearly demonstrated the superiority of
osimertinib compared with erlotinib or gefitinib in EGFR mutated nonpretreated NSCLC (median
PFS of 18.9 months versus 10.2 months).
However, several issues remain unknown or debated :
What are the mechanisms of resistance to osimertinib prescribed in first-line?
What are the consequences of prolonged exposure to osimertinib on the expression of
markers of response to immunotherapy?
Is there an association between kinetic parameters of ctDNA (circulating tumor DNA) and
prediction of response to osimertinib and/ or and prediction of therapeutic escape under
osimertinib? In order to respond to all these questions, this phase II trial will be the
first to systemically analyze the mechanisms of resistance to Osimertinib based on the
analysis of biopsy, and collection of plasma from all patients during the course of
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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