NCT02856893

Osimertinib Treatment on EGFR T790M Plasma Positive NSCLC Patients (APPLE)

APPLE Trial: Feasibility and Activity of AZD9291 (Osimertinib) Treatment on Positive PLasma T790M in EGFR Mutant NSCLC Patients

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 156 (actual)
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• NSCLC

Interventions

Type	Name	Description
DRUG	Osimertinib	Osimertinib 60 or 40 mg daily until progression
DRUG	Gefitinib	Gefitinib 250mg daily until progression

Timeline

• Start date: 2017-10-10
• Primary completion: 2022-09-20
• Completion: 2027-12-01
• First posted: 2016-08-05
• Last updated: 2025-10-31
• Results posted: 2025-10-31

Locations

23 sites across 6 countries: Belgium, France, Jordan, Poland, Slovenia, Spain

Regulatory

• FDA-regulated drug study