Neurocognition in NSCLC Patients Treated With Osimertinib or Osimertinib + WBI

Sponsor
Sun Yat-sen University
Study ID
NCT04829019
Phase
PHASE2
Status
Unknown

Conditions

  • Neurocognitive

Eligibility Criteria

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

Interventions

  • Osimertinib and whole-brain irradiation — RADIATION
    Osimertinib at a dose of 80 mg once per day, and WBI
  • Osimertinib — DRUG
    Osimertinib at a dose of 80 mg once per day, until unacceptable adverse events or disease progression occurred. WBI could be given to patients in experimental arm at any time base on investigator's decision after treatment initiated.

Study Details

This is a prospective, randomised, positive-controlled, study to assess the neurocognitive function of upfront Osimertinib compared to whole-brain irradiation (WBI) plus Osimertinib in EGFR-mutant (Ex 19Del and L858R) NSCLC patients with symptomatic brain metastases, as well as the efficacy and safety.

Key Dates

Start date
Apr 7, 2021
Status verified
Mar 2021
Primary completion
Apr 1, 2024
Completion
Oct 31, 2025

Study Design

Enrollment
88 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: whole-brain irradiation (WBI) plus Osimertinib
    Osimertinib plus WBI, with Osimertinib at a dose of 80 mg once per day.
  • Active Comparator: Osimertinib
    Osimertinib with WBI sequential therapy, with Osimertinib at a dose of 80 mg once per day.

Primary Outcome Measure

neurocognitive function (HVLT-R) [ Time Frame: at 4 months ]

Central Contacts