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

NCT05785208 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2023-03-27

No results posted yet for this study

Summary

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.

Conditions

  • Non Small Cell Lung Cancer

Interventions

DRUG

Osimertinib

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

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-28
Primary Completion
2024-02-28
Completion
2025-10-31

Countries

  • Italy

Study Locations

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Entities

Drugs

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 NCT05785208 on ClinicalTrials.gov