RecruitingPhase 2NCT06156527

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

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


Sponsor

National Cancer Center, Korea

Enrollment

120 participants

Start Date

Sep 5, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing lazertinib (a targeted lung cancer drug) alone versus lazertinib combined with bevacizumab (a drug that blocks blood vessel growth in tumors) in smokers with advanced non-small cell lung cancer (NSCLC) that has a specific gene mutation called EGFR. **You may be eligible if...** - You have been diagnosed with locally advanced or metastatic non-small cell lung cancer (not the squamous cell type) - Your tumor has an EGFR gene mutation - You are a smoker or have a smoking history - Your cancer can be measured on imaging - You have not received prior targeted therapy for EGFR-mutant lung cancer **You may NOT be eligible if...** - You have squamous cell lung cancer - Your tumor does not have an EGFR mutation - You have already been treated with EGFR-targeted therapy - You have conditions that make bevacizumab unsafe (such as active bleeding or blood clots) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLazertinib

Lazertinib 240mg, QD, daily

DRUGBevacizumab 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

View Full Details on ClinicalTrials.gov

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NCT06156527