Combining Ametinib and Bevacizumab for Advanced Lung Cancer Treatment

Efficacy and Safety of Ametinib Combined With Bevacizumab in First-line Treatment of Non-oligometastatic Advanced NSCLC With EGFR-mutations.

This study is testing if combining two drugs, ametinib and bevacizumab, can help people with advanced lung cancer and specific gene mutations live longer and feel better.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: The Second Affiliated Hospital of Shandong First Medical University (Academic / other)
• Drugs / interventions: radiation, bevacizumab, almonertinib, amitinib
• Locations: 1 site (Tai'an, Shandong)
• Trial ID: NCT05754736 on ClinicalTrials.gov

What this trial studies

This clinical study evaluates the effectiveness and safety of ametinib combined with bevacizumab as a first-line treatment for patients with advanced non-small cell lung cancer (NSCLC) who have specific EGFR mutations. It is a one-arm prospective study where participants receive the treatment and are monitored for efficacy every 6-8 weeks until disease progression or intolerable toxicity occurs. The study aims to assess various outcomes, including progression-free survival, overall survival, quality of life, and safety, while also examining the correlation between early mutation clearance and patient survival.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with advanced non-squamous NSCLC and confirmed EGFR mutations, including those with asymptomatic brain metastases.

Not a fit: Patients with oligometastatic intracranial disease or those with significant symptoms from increased intracranial pressure may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve outcomes for patients with advanced NSCLC with EGFR mutations.

How similar studies have performed: Other studies have shown promising results with similar combinations of targeted therapies in treating advanced NSCLC, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

* Male or female, ≥18 years old and ≤75years old;

  * Non-squamous non-small cell lung cancer (NSCLC) confirmed by pathology (including histology or cytology); ③ EGFR mutation positive (exon 19 deletion or exon 21 L858R mutation); (4) ≥3 intracranial metastases, asymptomatic brain metastases; (5) Never received antitumor therapy before;

    * There was at least 1 measurable intracranial and extracranial lesion in CT/MRI according to RECIST1.1 criteria.

      ⑦ Predicted survival ≥3 months;

      ⑧ ECOG score 0-1;

      ⑨ The main organs (liver, kidney, heart) function normally.

      ⑩ Sign informed consent forms.

Exclusion Criteria:

* The intracranial metastases were oligometastases;

  * There are symptoms of increased intracranial pressure; (3) Previous or co-existing malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix); (4) Patients with hypertension and can not be reduced to the normal range after antihypertensive drug treatment, have grade I coronary heart disease, grade I arrhythmia and grade I cardiac insufficiency;

    * Patients with definite tendency to gastrointestinal bleeding; ⑥ with hemoptysis symptoms; ⑦ Abnormal coagulation function (INR\>1.5, APTT\>1.5 ULN), with bleeding tendency; ⑧ Have a history of psychotropic drug abuse and can not abstain or have mental disorders; ⑨According to the investigator's judgment, Patients who have a serious concomitant disease that endangers the patient's safety or affects the patient's completion of the study, and who have previous or current objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, or severe impairment of lung function.

Where this trial is running

Tai'an, Shandong

• The Second Affiliated Hospital of Shandong First Medical University — Tai'an, Shandong, China (Recruiting)

Study contacts

• Principal investigator: Haiyan Liu — The Second Affiliated Hospital of Shandong First Medical University
• Study coordinator: Ying Kong

Conditions Non-small Cell Lung Cancer