Osimertinib or Docetaxel-bevacizumab as Third-line Treatment in EGFR T790M Mutated Non-Small Cell Lung Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Phase III Study of Osimertinib or Docetaxel-bevacizumab as Third-line Treatment in EGFR T790M Mutated Non-Small Cell Lung Cancer

Conditions
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Progression Free Survival

Intervention / Treatment
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* Drug: Osimertinib
* Drug: docetaxel, bevacizumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Docetaxel, bevacizumab<br>docetaxel, 75mg/m2, intravenous infusion on day 1. VEGF monoclonal antibody bevacizumab, 7.5 mg/m2, intravenous infusion on day 1, every 21days a cycle，until disease progression, intolerable toxicities, or patient death. | Drug: docetaxel, bevacizumab<br>* 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.<br>|
| Experimental: EGFR TKI<br>osimertinib 80mg oral once daily，until disease progression, intolerable toxicities, or patient death. | Drug: Osimertinib<br>* 80 mg oral daily; until disease progression, intolerable toxicities, or patient death.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression free survival |  | Average 10 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osimertinib, EGFR T790M Resistant Mutation, Docetaxel, Bevacizumab, Non Small Cell Lung