NCT02959749

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
147

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 5, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 9, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

February 14, 2018

Status Verified

November 1, 2016

Enrollment Period

2.2 years

First QC Date

November 5, 2016

Last Update Submit

February 13, 2018

Conditions

Progression Free Survival

Keywords

OsimertinibEGFR T790M Resistant MutationDocetaxelBevacizumabNon Small Cell Lung

Outcome Measures

Primary Outcomes (1)

  • progression free survival

    Average 10 months

Study Arms (2)

Docetaxel, bevacizumab

ACTIVE COMPARATOR

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

EGFR TKI

EXPERIMENTAL

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

Drug: Osimertinib

Interventions

OsimertinibDRUG

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

EGFR TKI
docetaxel, bevacizumabDRUG

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.

Docetaxel, bevacizumab

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • newly diagnosed thrombosis
  • anti-coagulation therapy
  • uncontrolled hypertension
  • uncontrolled nephropathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qingdao Central Hospital, Qingdao Cancer Hospital

Qingdao, Shandong, 266042, China

Location

Related Publications (1)

  • 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.

    PMID: 29858027DERIVED

MeSH Terms

Interventions

osimertinibDocetaxelBevacizumab

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

November 5, 2016

First Posted

November 9, 2016

Study Start

August 1, 2015

Primary Completion

October 1, 2017

Study Completion

December 31, 2017

Last Updated

February 14, 2018

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)