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

NCT04695925 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 294

Last updated 2025-10-15

No results posted yet for this study

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.

Conditions

  • Non-small Cell Carcinoma
  • EGFR Gene Mutation

Interventions

DRUG

Osimertinib

Osimertinib, 80mg, QD, p.o. until disease progression

DRUG

Pemetrexed

pemetrexed 500 mg/m2 intravenously every 3 weeks until disease progression

DRUG

Carboplatin

carboplatin area under curve 5 intravenously every 3 weeks for four cycles

Sponsors & Collaborators

  • Cancer Hospital of Guangxi Medical University

    collaborator OTHER

  • First People's Hospital of Foshan

    collaborator OTHER

  • Henan Cancer Hospital

    collaborator OTHER_GOV

  • Li Zhang, MD

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-29
Primary Completion
2025-11-01
Completion
2027-12-30
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

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 NCT04695925 on ClinicalTrials.gov