NSCLC Clinical Trial
Official title:
APPLE Trial: Feasibility and Activity of AZD9291 (Osimertinib) Treatment on Positive PLasma T790M in EGFR Mutant NSCLC Patients
The phase II APPLE trial gives the opportunity to prospectively validate liquid biopsies as a new standard for testing tumor progression compared with conventional radiological procedure in EGFR mutant advanced NSCLC patients. Moreover based on the sequential T790M test during treatment the investigators will assess the predictive value of liquid biopsies. APPLE trial will examine the best strategy for delivering osimertinib (upfront versus sequential treatment after 1st generation EGFR TKI) in EGFR mutant NSCLC patients. Finally, the trial will also explore the mechanisms of acquired resistance to Osimertinib based on the results of an optional biopsy upon progression.
Primary objective To evaluate the best strategy for delivering Osimertinib (AZD9291) in NSCLC patients with EGFR mutation. The objective is assessed by Progression Free Survival rate at 18 months (PFS-18). Secondary objectives - To evaluate PFS on Osimertinib measured from randomization by RECIST criteria 1.1 [Ref 33]. - To evaluate PFS measured from switching to Osimertinib by RECIST criteria 1.1 [Ref 33]. - To determine the proportion of patients receiving Osimertinib based on the determination of cfDNA T790M mutation positive. - To evaluate time to symptomatic brain metastases in patients with presence of brain metastases at study entry. - To evaluate PFS-2 (defined as the sum of the PFS to Gefitinib and the PFS to Osimertinib treatment). - To evaluate Overall Response Rate (ORR) to Osimertinib. - To evaluate the Treatment duration. - To evaluate Time to progression (TTP) on Osimertinib (measured from switching to osimertinib). - To evaluate Overall Survival (OS). - To evaluate time to brain progression (TTBP). - Safety. ;
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