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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

147 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2017-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Progression Free Survival

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

docetaxel, bevacizumab

Intervention Type 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.

EGFR TKI

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

Group Type EXPERIMENTAL

Osimertinib

Intervention Type DRUG

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

Interventions

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Osimertinib

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

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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