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

NCT02856893 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2025-10-31

Study results available
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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.

Conditions

Interventions

DRUG

Osimertinib

Osimertinib 60 or 40 mg daily until progression

DRUG

Gefitinib

Gefitinib 250mg daily until progression

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • European Organisation for Research and Treatment of Cancer - EORTC

    lead NETWORK

Principal Investigators

  • Rafal Dziadziuszko, MD PhD · Mecical University of Gdansk, Poland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-10
Primary Completion
2022-09-20
Completion
2027-12-31
FDA Drug
Yes

Countries

  • Belgium
  • France
  • Jordan
  • Poland
  • Slovenia
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02856893 on ClinicalTrials.gov