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

Sponsor
National Cancer Center, Korea
Study ID
NCT06156527
Phase
PHASE2
Status
Recruiting
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Conditions

  • Lazertinib

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Sep 5, 2023
Status verified
Nov 2023
Primary completion
Sep 5, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: single arm
    lazertinib single arm
  • Experimental: combination arm
    Lazertinib plus bevacizumab

Primary Outcome Measure

PFS [ Time Frame: every 9 weeks ]

Central Contacts