CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 156 enrolled / 156 target
Drug / intervention
Osimertinib +1 moredrug
Likely dose
Osimertinib 60 or 40 mg orally daily until progressionAI-extracted
Key inclusion· 9
  • ✓Pathologically confirmed adenocarcinoma of lung with EGFR activating mutations (Del19 or L858R only)
  • ✓Stage IV NSCLC
  • ✓Blood sample available for central cfDNA EGFR T790M testing
  • ✓Age ≥18 years
Key exclusion· 14
  • ✕Prior systemic anti-cancer therapy (chemotherapy, biologic, immunotherapy, or investigational drug) for locally advanced/metastatic NSCLC
  • ✕Prior EGFR-TKI treatment
  • ✕Major surgery (excluding vascular access) within 4 weeks before randomization
  • ✕Radiotherapy to >30% bone marrow or wide-field radiation within 4 weeks before randomization

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02856893
NCT02856893Phase 2CompletedMonitor (1.5/mo)Completion was 45mo ago
CompareCT.gov

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

European Organisation for Research and Treatment of Cancer - EORTC·interventional·Posted Aug 5, 2016·Updated Jun 2, 2026

In Brief

A Phase 2 clinical trial evaluating Osimertinib and Gefitinib for NSCLC. Completed, enrolled 156 participants across 23 sites in 6 countries.

Signals

Enrolling slower than its timeline implies

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNSCLC
CountriesBelgium, France, Jordan, Poland, Slovenia, Spain
CollaboratorsAstraZeneca

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedAug 5, 2016
Enrollment StartOct 10, 2017
Primary CompletionSep 20, 2022
Study CompletionAug 12, 2025
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 9.9 years ago

Arms & Interventions

Osimertinib till progressionexperimental

Osimertinib until PD according to RECIST 1.1

Drug: Osimertinib
Gefitinib till + blood test/progression than Osimertinibexperimental

Gefitinib until emergence of positive T790M status ("cfDNA T790M positive progression") followed by Osimertinib until second PD according to RECIST 1.1

Drug: OsimertinibDrug: Gefitinib
Gefitinib till progression than Osimertinibactive_comparator

Gefitinib until PD according to RECIST 1.1 followed by Osimertinib until PD according to RECIST 1.1

Drug: OsimertinibDrug: Gefitinib

Interventions

Osimertinibdrug

Osimertinib 60 or 40 mg daily until progression

Gefitinibdrug

Gefitinib 250mg daily until progression