Efficacy Study of Osimertinib in Treatment-naïve Patients With EGFR Mutant NSCLC According to TP53 Mutational Status.

Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study ID
NCT05785208
Phase
PHASE4
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • Osimertinib — DRUG
    Osimertinib will be administered at a dose of 80 mg daily until disease progression

Study Details

This is a prospective, biomarker-driven, open-label, clinical trial of osimertinib in treatment- naïve patients with EGFR mutant NSCLC, to evaluate the efficacy of osimertinib according to the TP53 mutational status.

Key Dates

Start date
Jun 28, 2022
Status verified
Mar 2023
Primary completion
Feb 28, 2024
Completion
Oct 31, 2025

Study Design

Enrollment
122 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ARM A: TP53 wilde-type
    Participants will receive osimertinib 80 mg once daily until disease progression or unacceptable toxicity.
  • Experimental: ARM B: TP53 mutant
    Participants will receive osimertinib 80 mg once daily until disease progression or unacceptable toxicity.

Primary Outcome Measure

Progression-Free Survival (PFS) According to RECIST v1.1 [ Time Frame: 24 months ]

Central Contacts

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