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

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.

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Key information

Conditions

Progression Free Survival

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Qingdao Central Hospital, Qingdao Cancer Hospital

Qingdao, Shandong, 266042, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Osimertinib

Drug

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

docetaxel, bevacizumab

Drug

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.

Primary outcomes

progression free survival

Time frame: Average 10 months

Sponsors and collaborators

Lead sponsor

Qingdao Central Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2015
Primary completion: 2017
Study completion: 2017
First posted: Nov 9, 2016
Registry last updated: Feb 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed