drugset / Trial / NCT05491811
Ensartinib in Combination With Bevacizumab in ALK-positive NSCLC Patients With TP53 Mutation
Phase 2
Active not recruiting
47 enrolled
Sun Yat-sen University
Central People's Hospital of Zhanjiang · collabFifth Affiliated Hospital, Sun Yat-Sen University · collabFirst Affiliated Hospital of Wenzhou Medical University · collabFirst People's Hospital of Foshan · collabGuangdong Provincial Agricultural Reclamation Central Hospital · collabGuangzhou Institute of Respiratory Disease · collabHebei Medical University Fourth Hospital · collabSecond Affiliated Hospital, School of Medicine, Zhejiang University · collabShenyang Chest Hospital · collabThe First Affiliated Hospital with Nanjing Medical University · collabUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology · collabWest China Hospital · collabYuebei People's Hospital · collabYunnan Cancer Hospital · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2022-08-01
- Primary completion
- 2024-08-31
- Completion
- 2026-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab | Monoclonal antibody | 7.5 mg/kg | Intravenous |
| Subject | Ensartinib | Small molecule | 225 mg | Oral |