NCT05491811

Ensartinib in Combination With Bevacizumab in ALK-positive NSCLC Patients With TP53 Mutation

Evaluate the Efficacy and Safety of Ensartinib and Bevacizumab in Patients With Advanced, ALK-Rearranged Combined With TP53 Mutation, Non-Small Cell Lung Cancer: A Prospective, Open-label, Multi-center, Single-arm, Phase II Trial

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, single-arm, multicenter, phase II study to investigate the efficacy and safety of Ensartinib plus Bevacizumab in metastatic anaplastic lymphoma kinase (ALK)-rearranged Non-Small Cell Lung Cancer (NSCLC) with TP53 mutation.

Detailed description

Patients with advanced or metastatic NSCLC with ALK positive and TP53 mutation were clinically confirmed. Medical history collection, physical examination, laboratory examination, concomitant diseases and medication records were taken according to the patient's diagnosis and treatment. Laboratory examination included but not limited to blood routine and blood biochemical examination. To determine whether patients were suitable for treatment with Ensartinib combined with Bevacizumab according to the entry and exclusion criteria. For patients who met the prescription, blood samples were collected within 1 week before medication. Imaging examination was performed every 6 weeks (±7 days) in the first 2 years and every 12 weeks (±7 days) in the second 2 years. Examination items included chest CT, head MRI; See if additional tests (e.g., bone scan, total abdominal augmentation) are needed based on the actual clinical situation. When the disease progresses, blood samples should be collected within 4 weeks after the disease progression, and if possible, tumor tissues of the progressive lesions after the disease progression should be collected. Patients can choose to continue to use the regimen recommended by the doctor if the doctor considers that the use of Ensartinib therapy or combination therapy may still bring benefit to the patient. The follow-up treatment plan, the best efficacy evaluation, and the duration of treatment were recorded. When the end point of follow-up was reached, that is, the patient died or was lost to follow-up, the date of death or loss and the main causes should be tracked and recorded in detail.

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Ensartinib	Participants will receive Ensartinib 225 mg oral once daily from baseline until disease progression, unacceptable toxicity, withdrawal of consent or death.
DRUG	Bevacizumab	Participants will receive 7.5 mg/kg intravenous on Day 1 of 21 day cycles (every 3 weeks) from baseline until disease progression, unacceptable toxicity, withdrawal of consent or death.

Timeline

• Start date: 2022-08-01
• Primary completion: 2024-08-31
• Completion: 2026-12-01
• First posted: 2022-08-08
• Last updated: 2024-09-19

Locations

1 site across 1 country: China