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NOT YET RECRUITING
NCT06557096
EARLY_PHASE1

CSF CTC-Capture-Guided EGFR-TKI and Bevacizumab Combination Therapy in EGFR-Mutant Advanced NSCLC

Sponsor: Second Affiliated Hospital of Nanchang University

View on ClinicalTrials.gov

Summary

clinical trial The goal of this clinical trial is to learn whether the treatment of advanced non-small cell lung cancer with EGFR-TKIs, when combined with bevacizumab in the presence of positive circulating tumor cells in the cerebrospinal fluid, has better therapeutic efficacy. The main questions it aims to answer are:1.When EGFR-TKIs are sequentially combined with bevacizumab along with EGFR-TKIs for first-line treatment of advanced non-small cell lung cancer, how long can the participants survive? 2.What medical problems do participants have when using EGFR-TKIs sequentially combined with bevacizumab in conjunction with EGFR-TKIs. Participants will: Receive EGFR-TKIs treatment for a duration of 3 months, and upon a positive cerebrospinal fluid tumor cell status, subsequently receive bevacizumab combined with EGFR-TKIs treatment until disease progression. Visit the clinic for check-ups and tests every two weeks, and have follow-up visits every six weeks after the treatment ends. Keep a record of their symptoms and disease progression.

Official title: Open-label, Single-Arm, Multicenter Clinical Study of EGFR-TKIs Sequentially Combined With Bevacizumab for the Treatment of EGFR-Mutant Advanced Non-Small Cell Lung Cancer, Based on Early Warning by CSF CTC Capture Technology

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2024-08-20

Completion Date

2028-07-31

Last Updated

2024-08-16

Healthy Volunteers

No

Interventions

DRUG

Osimertinib 80 MG

Osimertinib is taken orally at a dose of 80mg daily for a 28-day treatment period, followed by a sequential treatment of osimertinib 80mg daily taken orally for another 28 days.

DRUG

Bevacizumab

Sequential combination therapy with bevacizumab administered intravenously at a dosage of 7.5mg/kg of body weight on the first day of each cycle, with medication given once every 3 weeks, for a continuous treatment duration of 21 days.