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

Qingdao Central Hospital

Status and phase: Completed; Phase 3; Phase 2

Conditions: Progression Free Survival

Treatments: Drug: docetaxel, bevacizumab; Drug: Osimertinib

Study type: Interventional

Funder types: Other

Identifiers

NCT02959749

QingdaoCH20161101

Details and patient eligibility

About

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.

Enrollment: 147 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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147 participants in 2 patient groups

Docetaxel, bevacizumab

Active Comparator group

Description:

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.

Treatment:

Drug: docetaxel, bevacizumab

EGFR TKI

Experimental group

Description:

osimertinib 80mg oral once daily，until disease progression, intolerable toxicities, or patient death.

Treatment:

Drug: Osimertinib