NCT04636593

A Phase 2 Trial of Almonertinib With Concurrent Radiotherapy in The Treatment of Local Advanced EGFR-mutant NSCLC

Almonertinib With Concurrent Radiotherapy in The Treatment of Unresectable, Stage Ⅲ Non-small-cell Lung Cancer Harboring EGFR Mutations: A PhaseⅡCohort Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (estimated)
• Sponsor: First People's Hospital of Hangzhou · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Previous clinical studies showed there is a potential value of EGFR-TKI in local advanced EGFR-mutant NSCLC, while the risk of radiation pneumonia in combination of EGFR-TKI with thoracic radiotherapy is unknown. This study aims to explore the safety and efficacy of concurrent almonertinib, a new third-generation EGFR-TKI drug, with radiotherapy in local advanced EGFR-mutant NSCLC patients.

Detailed description

Doublet platinum-based therapy combined with radiotherapy remains the standard treatment for first-line management of unresectable stage III NSCLC patients, regardless of the EGFR mutation status. But the 5-year survival rate is not satisfying. Previous clinical studies showed there is a potential value but also a high risk of radiation pneumonia in treatment regimens of combination TKI with radiotherapy. This study intends to explore the safety and efficacy of concurrent almonertinib, a new third-generation EGFR-TKI drug, with radiotherapy in EGFR-sensitive mutated locally advanced NSCLC patients.

Conditions

• Non Small Cell Lung Cancer
• Stage III NSCLC
• EGFR Activating Mutation

Interventions

Type	Name	Description
DRUG	Almonertinib	All enrolled patients underwent positioning CT scans before the initial treatment, a radiotherapy plan was made for each patient, and the lung V20 of each patient was calculated. Patients with lung V20 ≥ 28% were enrolled in group A: Almonertinib induction therapy was given for 2 months firstly, followed by Almonertinib combined with radiotherapy; patients with lung V20\<28% were enrolled in group B: Almonertinib was synchronized with radiotherapy initially.

Timeline

• Start date: 2020-08-01
• Primary completion: 2021-12-31
• Completion: 2022-12-31
• First posted: 2020-11-19
• Last updated: 2021-01-12

Locations

1 site across 1 country: China