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RECRUITING
NCT06156527
PHASE2

A Randomized Phase II Study of LAZE rtiNib Alone Versus Lazertinib Plus bevaCizumab for NSCLC With EGFR + & Smoker

Sponsor: National Cancer Center, Korea

View on ClinicalTrials.gov

Summary

Using gefitinib or Osimertinib, an EGFR tyrosine kinase inhibitor (TKI), in patients with active mutations in epithelial cell growth factor receptors (EGFR), 70% response rate (CR+PR) and 90% disease control rate (CR+PR+SD) compared to the current non-small cell therapy, which is significant in the EFRT treatment. However, resistance causes recurrence in most patients. Therefore, it is necessary to develop a more effective treatment. Recently, in Japan, combined allotinib and bevacizumab therapy as primary therapy in non-small cell lung cancer patients with EGFR mutation improved PFS statistically significantly compared to allotinib monotherapy, suggesting the possibility of a new treatment (Hazard ratio 0.605, 95% CI 0.417-0.877, P=0.016). In addition, subsequent osmutinib and bevacizumab combination therapy showed a significant difference in PFS in the smoker group, although they did not show significant improvement in PFS in the entire patient group. (Hazard ratio 0.605, 95% CI 0.417-0.877, P=0.016). Since EGFR mutated lung cancer is highly frequent in Korea, it is necessary to develop more effective treatments for such patients. Therefore, we propose this clinical trial to find out the efficacy of lasertinib and bevacizumab combination therapy.

Official title: A Randomized Phase II Study of LAZE Rti N ib Alone Versus Lazertinib Plus Beva C Izumab for A Dvanced Non Small Cell Lung Cancer With Epidermal Growth Factor Receptor Activating Mutations and Smoking History

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2023-09-05

Completion Date

2026-12-31

Last Updated

2023-12-05

Healthy Volunteers

No

Conditions

Interventions

DRUG

Lazertinib

Lazertinib 240mg, QD, daily

DRUG

Bevacizumab Injectable Product

Bevacizumab: 15mg/kg IV every 3 weeks

Locations (5)

The Catholic University of Korea, St. Vincent's Hospital

Suwon, Gyeonggi-do, South Korea

National Cancer Center

Goyang-si, Gyeunggi-do, South Korea

AJOU university hospital

Suwon, Gyeunggi-do, South Korea

Yonsei University Health System, Severance Hospital

Seoul, South Korea

Gangnam Severance Hospita

Seoul, South Korea