Progression Free Survival
Conditions
Keywords
Osimertinib, EGFR T790M Resistant Mutation, Docetaxel, Bevacizumab, Non Small Cell Lung
Brief summary
Acquired epidermal growth factor receptor (EGFR) T790M mutation is the most common genetic change after resistant to first generation EGFR tyrosine kinase inhibitor (EGFR TKI) in non-small cell lung cancer. After a 10 to 14 months median progression-free survival with the treatment of first generation EGFR TKI, half of patients will get disease progression.For patients progression after treated with first line EGFR TKI and second line double bullets chemotherapy or chemotherapy then EGFR TKI, optimal third line therapy is quite critical important for benefit patients' survival. We conducted this study was aimed to compare the efficacy and toxicity between osimertinib and docetaxel-bevacizumab as the third line therapy in patients with local advanced or metastatic non-squamous cell lung cancer.
Interventions
DRUGOsimertinib
80 mg oral daily; until disease progression, intolerable toxicities, or patient death.
DRUGdocetaxel, bevacizumab
Docetaxel and bevacizumab are common used in third line therapy in non-small cell lung cancer if not used before. Docetaxel (75 mg/m2) intravenous infusion on day 1 and bevacizumab (7.5 mg/kg) on day 1 every 21days a cycle, until disease progression, intolerable toxicities, or patient death.
Sponsors
Qingdao Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* local advanced or metastatic non-small cell lung cancer * large cell lung carcinoma or adenocinoma * Previously treated by TKI-Chemotherapy or Chemotherapy-TKI * EGFR T790M positive * No uncontrolled hypertension * No active bleeding or thrombosis in recent 6 months * No previously treated with VEGF antibody
Exclusion criteria
* newly diagnosed thrombosis * anti-coagulation therapy * uncontrolled hypertension * uncontrolled nephropathy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival | Average 10 months |
Countries
China
Outcome results
None listed