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

Primary Purpose

Progression Free Survival

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Osimertinib
docetaxel, bevacizumab
Sponsored by
Qingdao Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Progression Free Survival focused on measuring Osimertinib, EGFR T790M Resistant Mutation, Docetaxel, Bevacizumab, Non Small Cell Lung

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Qingdao Central Hospital, Qingdao Cancer Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Docetaxel, bevacizumab

EGFR TKI

Arm 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.

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

Outcomes

Primary Outcome Measures

progression free survival

Secondary Outcome Measures

Full Information

First Posted
November 5, 2016
Last Updated
February 13, 2018
Sponsor
Qingdao Central Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02959749
Brief Title
Osimertinib or Docetaxel-bevacizumab as Third-line Treatment in EGFR T790M Mutated Non-Small Cell Lung Cancer
Official Title
Phase III Study of Osimertinib or Docetaxel-bevacizumab as Third-line Treatment in EGFR T790M Mutated Non-Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
December 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Qingdao Central Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Progression Free Survival
Keywords
Osimertinib, EGFR T790M Resistant Mutation, Docetaxel, Bevacizumab, Non Small Cell Lung

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
147 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Docetaxel, bevacizumab
Arm Type
Active Comparator
Arm 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.
Arm Title
EGFR TKI
Arm Type
Experimental
Arm Description
osimertinib 80mg oral once daily，until disease progression, intolerable toxicities, or patient death.
Intervention Type
Drug
Intervention Name(s)
Osimertinib
Intervention Description
80 mg oral daily; until disease progression, intolerable toxicities, or patient death.
Intervention Type
Drug
Intervention Name(s)
docetaxel, bevacizumab
Intervention Description
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 Outcome Measure Information:
Title
progression free survival
Time Frame
Average 10 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Qingdao Central Hospital, Qingdao Cancer Hospital
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266042
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29858027
Citation
Nie K, Zhang Z, Zhang C, Geng C, Zhang L, Xu X, Liu S, Wang S, Zhuang X, Lan K, Ji Y. Osimertinib compared docetaxel-bevacizumab as third-line treatment in EGFR T790M mutated non-small-cell lung cancer. Lung Cancer. 2018 Jul;121:5-11. doi: 10.1016/j.lungcan.2018.04.012. Epub 2018 Apr 17.
Results Reference
derived

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

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