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

Progression Free Survival Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02959749
• Other study ID #: QingdaoCH20161101
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: November 5, 2016
• Last updated: February 13, 2018
• Start date: August 2015
• Est. completion date: December 31, 2017

Study information

• Verified date: November 2016
• Source: Qingdao Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: December 31, 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Progression Free Survival

Intervention

Drug:
• Osimertinib
80 mg oral daily; until disease progression, intolerable toxicities, or patient death.
• 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.

Locations

Country	Name	City	State
China	Qingdao Central Hospital, Qingdao Cancer Hospital	Qingdao	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Qingdao Central Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression free survival		Average 10 months