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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02959749
Recruitment Status : Completed
First Posted : November 9, 2016
Last Update Posted : February 14, 2018
Sponsor:
Information provided by (Responsible Party):
Youxin Ji, 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.

Condition or disease Intervention/treatment Phase
Progression Free Survival Drug: Osimertinib Drug: docetaxel, bevacizumab Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 147 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase III Study of Osimertinib or Docetaxel-bevacizumab as Third-line Treatment in EGFR T790M Mutated Non-Small Cell Lung Cancer
Study Start Date : August 2015
Actual Primary Completion Date : October 2017
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
Drug: docetaxel, 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.

Experimental: EGFR TKI
osimertinib 80mg oral once daily,until disease progression, intolerable toxicities, or patient death.
Drug: Osimertinib
80 mg oral daily; until disease progression, intolerable toxicities, or patient death.




Primary Outcome Measures :
  1. progression free survival [ Time Frame: Average 10 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02959749


Locations
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China, Shandong
Qingdao Central Hospital, Qingdao Cancer Hospital
Qingdao, Shandong, China, 266042
Sponsors and Collaborators
Qingdao Central Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Youxin Ji, Director, Qingdao Central Hospital
ClinicalTrials.gov Identifier: NCT02959749    
Other Study ID Numbers: QingdaoCH20161101
First Posted: November 9, 2016    Key Record Dates
Last Update Posted: February 14, 2018
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Youxin Ji, Qingdao Central Hospital:
Osimertinib
EGFR T790M Resistant Mutation
Docetaxel
Bevacizumab
Non Small Cell Lung
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Disease Progression
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Bevacizumab
Docetaxel
Osimertinib
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors