OncRef

Clinical Trial: NCT04695925

Osimertinib Monotherapy or Combination With Chemotherapy for Advanced NSCLC Concurrent EGFR and TP53 Mutations

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 3

Lead Sponsor:Li Zhang, MD
Information Provided By:Sun Yat-sen University
Last Update Posted:2025-10-15

Study Overview

Brief Summary

This is a phase III randomized trial in patients with advanced non-squamous NSCLC harboring EGFR-sensitizing mutations and concurrent TP53 mutations with a performance status of 0 to1 who are planned to receive first-line therapy.

Official Title

A Phase III, Multicentre, Randomized Controlled Study Comparing Osimertinib Monotherapy to Combination Therapy With Osimertinib, Carboplatin and Pemetrexed for Untreated Patients With Advanced Nonsquamous Non-Small Cell Lung Cancer With Concurrent EGFR and TP53 Mutations(TOP)

Conditions

Non-small Cell Carcinoma, EGFR Gene Mutation

Intervention / Treatment

  • Drug: Osimertinib
  • Drug: Pemetrexed
  • Drug: Carboplatin

Other Study ID Numbers

  • ESR-21-21647

Start Date (Actual)

2021-03-29

Primary Completion Date (Estimated)

2025-11-01

Study Completion Date (Estimated)

2027-12-30

Enrollment (Actual)

294

Study Type

Interventional

Phase

Phase 3