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

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.

Conditions

• Non-Small Cell Lung Cancer

Interventions

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.

Sponsors & Collaborators

• First Affiliated Hospital of Wenzhou Medical University

  collaborator OTHER

• Second Affiliated Hospital, School of Medicine, Zhejiang University

  collaborator OTHER

• Shenyang Chest Hospital

  collaborator OTHER

• Hebei Medical University Fourth Hospital

  collaborator OTHER

• First People's Hospital of Foshan

  collaborator OTHER

• Guangzhou Institute of Respiratory Disease

  collaborator OTHER

• Central People's Hospital of Zhanjiang

  collaborator OTHER

• Guangdong Provincial Agricultural Reclamation Central Hospital

  collaborator UNKNOWN

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  collaborator OTHER

• West China Hospital

  collaborator OTHER

• The First Affiliated Hospital with Nanjing Medical University

  collaborator OTHER

• Yuebei People's Hospital

  collaborator OTHER

• Yunnan Cancer Hospital

  collaborator OTHER

• Fifth Affiliated Hospital, Sun Yat-Sen University

  collaborator OTHER

• Sun Yat-sen University

  lead OTHER

Principal Investigators

• Zhang Li, MD · Sun Yat-Sen University Cancer Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-08-01

Primary Completion

2024-08-31

Completion

2026-12-31

Countries

• China

Study Locations