Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2026-02-28 @ 6:34 PM
Study NCT ID:
NCT02856893
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-31
First Post:
2016-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Osimertinib Treatment on EGFR T790M Plasma Positive NSCLC Patients (APPLE)
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
Study Overview
Official Title:
APPLE Trial: Feasibility and Activity of AZD9291 (Osimertinib) Treatment on Positive PLasma T790M in EGFR Mutant NSCLC Patients
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
APPLE
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| ESR-15-11406 | OTHER | Astra Zeneca | View |