Actively Recruiting

Phase 2
Age: 19Years +
All Genders
NCT06156527

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

Led by National Cancer Center, Korea · Updated on 2023-12-05

120

Participants Needed

5

Research Sites

173 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 19Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed locally progressive or metastatic non-small cell lung cancer (stage IIIB or IV) excluding squamous cell carcinoma
  • At least one measurable tumor lesion according to RECIST 1.1 criteria
  • Presence of EGFR mutation (exon 19 deletion or L858R)
  • History of smoking (more than 100 cigarettes in lifetime), including current smokers
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate blood counts: ANC ≥ 1,500/uL, hemoglobin ≥ 9.0 g/dL, platelets ≥ 100,000/uL
  • Adequate liver function: total bilirubin < 1× upper normal limit, AST and ALT < 2.5× upper normal limit (with exceptions for interruptions)
  • Adequate kidney function with creatinine clearance ≥ 50 mL/min or acceptable proteinuria test results
  • If prior radiation therapy was received, appropriate time has passed since treatment (12 weeks for lung lesions or bone metastasis, 2 weeks for non-chest areas)
  • Specified minimum time intervals passed since prior surgeries or procedures (e.g., 4 weeks post-surgery)
  • Negative pregnancy test for women of childbearing potential within 7 days prior to treatment
  • Agreement to use two reliable contraceptive methods for 180 days after last study drug dose for participants and their partners
  • Willingness to participate and provide informed consent
Not Eligible

You will not qualify if you...

  • Patients with other cancers within the past 3 years except certain treated cancers (cervical, skin, thyroid, prostate)
  • History of significant bleeding within 3 months prior to enrollment
  • Previous chemotherapy for advanced lung cancer or systemic anticancer drugs recently (allowed if ended 6 months prior)
  • Evidence of tumor invasion into major blood vessels
  • Scheduled major surgery within 24 hours of first bevacizumab dose
  • Use of high-dose aspirin or anticoagulants/thrombolytics recently
  • Use of potent CYP3A4 inducers that cannot be stopped before treatment
  • Interstitial lung disease (ILD) or related lung conditions
  • Use or planned use of bisphosphonates
  • Uncontrolled brain or spinal metastases unless stable and treated epilepsy
  • Significant eye surface abnormalities or corneal issues
  • History of bleeding disorders or coagulopathy
  • Uncontrolled high blood pressure
  • Significant active cardiovascular disease within 6 months
  • Abnormal heart rhythm or conditions increasing risk of arrhythmia
  • Non-healing wounds, active ulcers, or fractures
  • Active infections or uncontrolled systemic diseases
  • Hypersensitivity to study drugs, related compounds, or certain biological products
  • Pregnant or breastfeeding women

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 5 locations

1

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

Suwon, Gyeonggi-do, South Korea, 16247

Not Yet Recruiting

2

National Cancer Center

Goyang-si, Gyeunggi-do, South Korea, 10408

Actively Recruiting

3

AJOU university hospital

Suwon, Gyeunggi-do, South Korea, 16499

Not Yet Recruiting

4

Yonsei University Health System, Severance Hospital

Seoul, South Korea, 03722

Not Yet Recruiting

5

Gangnam Severance Hospita

Seoul, South Korea, 06273

Not Yet Recruiting

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Research Team

B

Beung-Chule AHN

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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