VIC-1911 Combined With Osimertinib for EGFR -Mutant Non-small Cell Lung Cancer — VIC-1911  

Advanced Non-small Cell Lung Cancer Clinical Trial

Official title: Phase I Clinical Study of VIC-1911 Combined With Osimertinib in the Treatment of Advanced Non-small Cell Lung Cancer With EGRF- Mutation

Status Recruiting

Clinical Trial Summary

This is a nonrandomized, open phase I dose escalation and extension clinical study designed to evaluate Aurora A inhibitor VIC-1911 tablets in combination with oxitinib in Chinese patients with advanced non-small cell lung cancer The safety, tolerability, pharmacokinetic characteristics and preliminary antitumor efficacy were analyzed.

The entire study included the screening period (28 days prior to initialadministration of the investigational drug) and the treatment period (Cycle) EoT is defined as disease progression or intolerable toxicity or premature withdrawal Out]) and the safety follow-up period (28 days after EoT). During dose increments and expansions, subjects followed Safety assessment, PK blood collection, imaging examination and efficacy assessment were performed during the visit plan. Observation subject The safety, tolerability, and occurrence of DLT until disease progression, occurrence of intolerable toxicity, Death, withdrawal of informed consent, loss of follow-up or termination of the study by the sponsor shall prevail.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Advanced Non-small Cell Lung Cancer
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms

• NCT number: NCT05489731
• Study type: Interventional
• Source: Jiesi Yingda Pharmaceutical Technology (Suzhou) Co., Ltd.
• Contact: li zhang, professor
• Phone: 13902282893
• Email: zhangli6@mail.sysu.edu.cn
• Status: Recruiting
• Phase: Phase 1
• Start date: September 21, 2022
• Completion date: April 24, 2024