NCT04695925

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

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)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 294 (actual)
• Sponsor: Li Zhang, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a multicenter, randomized, open label, phase III study comparing the progression free survival, overall survival, response rate, toxicity, quality of life between Osimertinib monotherapy and combination of osimertinib, pemetrexed, carboplatin in first-line treatment of advanced non-small cell lung cancer patients with concurrent EGFR and TP53 mutation. Besides, the association between other genetic mutations and efficacy will also be analyzed as exploratory endpoint. Eligible patients will be randomized to receive either osimertinib or osimertinib combined with pemetrexed and carboplatin in a 1:1 ratio.

Conditions

• Non-small Cell Carcinoma
• EGFR Gene Mutation

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-03-29
• Primary completion: 2025-11-01
• Completion: 2027-12-30
• First posted: 2021-01-05
• Last updated: 2025-10-15

Locations

2 sites across 1 country: China

Regulatory

• FDA-regulated drug study