Clinical trial NCT04575415: Bevacizumab Plus EGFR-TKIs in Chinese Patients With EGFR-mutant NSCLC: a Real-world Study
Official title: Bevacizumab Plus EGFR Tyrosine Kinase Inhibitors in Chinese Patients With Stage IIIB-IV EGFR-mutant Non-small Cell Lung Cancer: a Prospective,Multicenter, Non-interventional,Real-world Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: NSCLC
Lead sponsor: Guangdong Association of Clinical Trials
Sponsor class: OTHER
First posted: 2020-10-05
Enrollment: 272
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Histologically or cytologically documented inoperable, locally advanced (Stage IIIB, IIIC) or metastatic (Stage IV) non-squamous NSCLC with EGFR exon 19 deletion or/and exon 21L858R mutation, with or without EGFR T790M mutation, who meet the inclusion criteria will be enrolled in this study.

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Progression-free survival (PFS) for bevacizumab plus first-generation EGFR-TKIs by investigator using RECIST v1.1
timeFrame: This is a real-world study. The estimated median PFS for bevacizumab plus first-generation EGFR-TKIs is 18 months according to previous data.
measure: Progression-free survival (PFS) for bevacizumab plus second-generation EGFR-TKIs by investigator using RECIST v1.1
timeFrame: This is a real-world study. The estimated median PFS for bevacizumab plus second-generation EGFR-TKIs is 20 months according to previous data.
measure: Progression-free survival (PFS) for bevacizumab plus third-generation EGFR-TKIs by investigator using RECIST v1.1
timeFrame: This is a real-world study. The estimated median PFS for bevacizumab plus third-generation EGFR-TKIs is 22 months according to previous data.
Secondary outcomes:
measure: Objective response rate (ORR) by investigator using RECIST v1.1
timeFrame: Baseline overall tumor assessment can be performed up to 28 days after the first-dose of treatment. Post-baseline assessment will be performed every six weeks until 1st disease progression, through study completion, an average of 2 years.
measure: Disease control rate (DCR) by investigator using RECIST v1.1
timeFrame: Baseline overall tumor assessment can be performed up to 28 days after the first-dose of treatment. Post-baseline assessment will be performed every six weeks until 1st disease progression, through study completion, an average of 2 years.
measure: Overall survival
timeFrame: The primary analysis on overall survival is espected to perform on 48 months of follow-up.
measure: Incidence of Treatment-Emergent Adverse Events using CTCAE V5.0
timeFrame: This is a real-world study. Safety of the combination treatment is expected to perform until the study completion, an average of 1.5 years,according to CTCAE V5.0.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
Study officials:
affiliation: Guangdong Provincial People's Hospital
name: Qing Zhou, PhD
role: PRINCIPAL_INVESTIGATOR
References: