NCT05267288

Phase II Study of Afatinib Plus Bevacizumab in the Treatment Epidermal Growth Factor Receptor (EGFR) Exon G719X, S768I, and L861Q Mutation Metastatic Non-Small Cell Lung Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Qingdao Central Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

There is no report afatinib plus bevacizumab in the treatment of EGFR G719X, S768I, and L861Q single or compond mutation of metastatic non-small-cell lung cancer (NSCLC). The purpose of this study is to study afatinib combined with bevacizumab in the management of it.

Detailed description

Lung cancer is one of the most common types of cancer and is the most common cause of death from cancer (almost 20 percent \[%\] of cancer deaths); NSCLC accounts for 80% to 85% of lung cancers. The hypothesis is that afatinib plus bevacizumab in patients with metastatic NSCLC characterized by EGFRuncommon mutations with G719X, S768I, and L861Q. Efficacy assessments will include disease assessment, symptomatic progression and patient-reported outcome. Safety assessments will include physical examinations, vital signs, electrocardiograms (ECGs), Eastern Cooperative Oncology Group (ECOG) performance status and clinical safety laboratory assessments (serum chemistry, hematology, coagulation, and urinalysis).

Conditions

• PFS

Interventions

Type	Name	Description
DRUG	afatinib	afatinib 40mg oral, bevacizumab 15mg/kg iv, every 21days, until progression disease, untolerated toxicities, or patient death.

Timeline

• Start date: 2021-02-01
• Primary completion: 2024-12-01
• Completion: 2025-06-01
• First posted: 2022-03-04
• Last updated: 2023-03-29

Locations

2 sites across 1 country: China