NSCLC
Conditions
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.
Interventions
DRUGBevacizumab
Bevacizumab 15mg/kg or clinical routine dose by intravenous drip infusion on day 1 of a 21-day cycle
DRUGErlotinib
Erlotinib 150mg, orally once a day
DRUGGefitinib
Gefitinib 250mg, orally once a day
DRUGIcotinib
Icotinib 125mg three times a day
DRUGAfatinib
Afatinib 40 mg or clinical routine dose once daily
DRUGDacomitinib
Dacomitinib 45mg or clinical routine dose once daily
DRUGOsimertinib
Osimertinib 80 mg once daily
Sponsors
Guangdong Association of Clinical Trials
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) for bevacizumab plus first-generation EGFR-TKIs by investigator using RECIST v1.1 | This is a real-world study. The estimated median PFS for bevacizumab plus first-generation EGFR-TKIs is 18 months according to previous data. | To evaluate the efficacy of bevacizumab combined with first-generation EGFR-TKIs in patients with EGFR-mutant NSCLC as measured by investigators |
| Progression-free survival (PFS) for bevacizumab plus second-generation EGFR-TKIs by investigator using RECIST v1.1 | This is a real-world study. The estimated median PFS for bevacizumab plus second-generation EGFR-TKIs is 20 months according to previous data. | To evaluate the efficacy of bevacizumab combined with second-generation EGFR-TKIs in patients with EGFR-mutant NSCLC as measured by investigators. |
| Progression-free survival (PFS) for bevacizumab plus third-generation EGFR-TKIs by investigator using RECIST v1.1 | This is a real-world study. The estimated median PFS for bevacizumab plus third-generation EGFR-TKIs is 22 months according to previous data. | To evaluate the efficacy of bevacizumab combined with third-generation EGFR-TKIs in patients with EGFR-mutant NSCLC as measured by investigators. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) by investigator using RECIST v1.1 | 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. | To evaluate the efficacy of bevacizumab combined with EGFR-TKIs in patients with NSCLC harbouring activating EGFR mutations, with or without EGFR T790M mutation,as measured by investigators assessed objective response rate using RECIST v1.1 |
| Incidence of Treatment-Emergent Adverse Events using CTCAE V5.0 | 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. | To evaluate the incidence of Treatment-Emergent Adverse Events of bevacizumab combined with EGFR-TKIs in patients with NSCLC harbouring activating EGFR mutations,with or without EGFR T790M mutation. |
| Disease control rate (DCR) by investigator using RECIST v1.1 | 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. | Disease control rate (DCR) will be analyzed using similar method as objective response rate. |
| Overall survival | The primary analysis on overall survival is espected to perform on 48 months of follow-up. | To evaluate the efficacy of bevacizumab combined with EGFR-TKIs in patients with NSCLC harbouring activating EGFR mutations,with or without EGFR T790M mutation,as measured by investigators assessed overall survival. |
Countries
China
Contacts
Primary ContactQing Zhou, PhD
Backup ContactChongrui Xu, PhD
Outcome results
None listed