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

Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Study ID
NCT02856893
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Osimertinib — DRUG
    Osimertinib 60 or 40 mg daily until progression
  • Gefitinib — DRUG
    Gefitinib 250mg daily until progression

Study Details

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.

Key Dates

Start date
Oct 10, 2017
Status verified
May 2026
Primary completion
Sep 20, 2022
Completion
Aug 12, 2025

Study Design

Enrollment
156 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Osimertinib till progression
    Osimertinib until PD according to RECIST 1.1
  • Experimental: Gefitinib till + blood test/progression than Osimertinib
    Gefitinib until emergence of positive T790M status ("cfDNA T790M positive progression") followed by Osimertinib until second PD according to RECIST 1.1
  • Active Comparator: Gefitinib till progression than Osimertinib
    Gefitinib until PD according to RECIST 1.1 followed by Osimertinib until PD according to RECIST 1.1

Primary Outcome Measure

PFS Rate at 18 Months [ Time Frame: 18 months after randomization ]

Related coverage on Hipa.ai

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