Bevacizumab Plus EGFR-TKIs in Chinese Patients With EGFR-mutant NSCLC: a Real-world Study (BELLA)

Guangdong Association of Clinical Trials

Status: Unknown

Conditions: NSCLC

Treatments: Drug: Bevacizumab; Drug: Gefitinib; Drug: Dacomitinib; Drug: Afatinib; Drug: Icotinib; Drug: Osimertinib; Drug: Erlotinib

Study type: Observational

Funder types: Other

Identifiers

NCT04575415

CTONG1905

Details and patient eligibility

About

This study is a prospective, multicenter, real-world study to investigate the efficacy and safety of bevacizumab plus epidermal growth factor (EGFR) Tyrosine Kinase Inhibitors in Chinese Patients With Stage IIIB/IV EGFR-mutant Non-small Cell Lung Cancer.

Enrollment: 272 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Patients must meet the following criteria for study entry:

  1. Signed Informed Consent Form.

  2. Age≥18 years.

  3. Histologically or cytologically documented inoperable, locally advanced (Stage IIIB, IIIC), metastatic (Stage IV) or recurrent non-squamous NSCLC.

  4. An exon 19 deletion mutation or exon 21 L858R mutation in EGFR has been found clinically, with or without EGFR T790M mutation

  5. Eastern Cooperative Oncology Group performance status 0-2 or KPS ≥60

  6. Previous EGFR-TKIs or anti-angiogenic agents or systemic cytotoxic chemotherapy for locally advanced, metastatic or recurrent disease has not been performed.

     Exclusion Criteria:

• Patients who meet any of the following criteria will be excluded from study entry:

  1. Squamous carcinoma or mixed non-small cell lung cancer with squamous component.
  2. Potential hazard for receiving EGFR-TKIs or bevacizumab by clinical evaluations
  3. Previous history of receiving EGFR-TKIs or bevacizumab treatment prior to study enrollment
  4. Suspected or diagnosed leptomeningeal metastases
  5. Chest radiotherapy within 3 months prior to study enrollment
  6. Open surgery within 4 weeks prior to study enrollment

Trial design

272 participants in 3 patient groups

Arm 1:Bevacizumab plus Erlotinib/Gefitinib/Icotinib

Description:

Patients with EGFR-mutant NSCLC would receive bevacizumab plus first-generation EGFR-TKIs in clinical routine care. Bevacizumab 15 mg/kg or clinical routine dose would be intravenous infusion on day 1 once every 3 weeks. Erlotinib 150 mg tablets once daily or Gefitinib 250mg once daily or Icotinib 125mg three times a day would be administered.

Treatment:

Drug: Erlotinib

Drug: Icotinib

Drug: Gefitinib

Drug: Bevacizumab

Arm 2:Bevacizumab plus Afatinib/Dacomitinib

Description:

Patients with EGFR-mutant NSCLC would receive bevacizumab plus second-generation EGFR-TKIs in clinical routine care. Bevacizumab 15 mg/kg or clinical routine dose would be intravenous infusion on day 1 once every 3 weeks.Afatinib 40 mg or clinical routine dose once daily or Dacomitinib 45mg or clinical routine dose once daily or clinical routine dose would be administered.

Treatment:

Drug: Dacomitinib

Drug: Afatinib

Drug: Bevacizumab

Arm 3:Bevacizumab plus Osimertinib

Description:

Patients with EGFR-mutant NSCLC would receive bevacizumab plus third-generation EGFR-TKIs in clinical routine care. Bevacizumab 15 mg/kg or clinical routine dose would be intravenous infusion on day 1 once every 3 weeks. Osimertinib 80 mg tablets once daily would be administered.

Treatment:

Drug: Osimertinib

Drug: Bevacizumab