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

Phase 2

Completed

• Conditions: Progression Free Survival
• Interventions: Drug: Osimertinib; Drug: docetaxel, bevacizumab

• Registration Number: NCT02959749
• Lead Sponsor: Qingdao Central Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08
• Status Verified: 2016-11
• Study First Submitted: 2016-11-05
• Study First Submitted QC: 2016-11-07
• Study First Posted: 2016-11-09
• Primary Completion: 2017-10
• Study Completion: 2017-12-31
• Last Update Submitted: 2018-02-13
• Last Update Posted: 2018-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 147

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EGFR TKI	Osimertinib	osimertinib 80mg oral once daily，until disease progression, intolerable toxicities, or patient death.
Docetaxel, bevacizumab	docetaxel, bevacizumab	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.

Primary Outcome Measures

Name	Time	Method
progression free survival	Average 10 months

Trial Locations

Locations (1)

Qingdao Central Hospital, Qingdao Cancer Hospital; 🇨🇳 Qingdao, Shandong, China