Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-25 @ 1:26 AM
NCT ID:
NCT02856893
Brief Summary:
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.
Detailed Description:
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 (PFSR-OSI-18).
Secondary objectives
* To evaluate PFS while receiving osimertinib measured from randomization by RECIST criteria 1.1.
* To evaluate PFS measured from switching to osimertinib by RECIST criteria 1.1.
* To determine the proportion of patients receiving osimertinib based on the determination of cfDNA T790M mutation positive.
* To evaluate PFS-2.
* 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 brain progression free survival (BPFS).
* Safety.
Study:
NCT02856893
Study Brief:
Protocol Section:
NCT02856893