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Report for Clinical Trial NCT02959749

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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

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.

NCT02959749 Progression Free Survival
MeSH: Carcinoma, Non-Small-Cell Lung Disease Progression
HPO: Non-small cell lung carcinoma

2 Interventions

Name: Osimertinib

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

Type: Drug

EGFR TKI

Name: docetaxel, bevacizumab

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.

Type: Drug

Docetaxel, bevacizumab


Primary Outcomes

Measure: progression free survival

Time: Average 10 months

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 T790M

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

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

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

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 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 Progression Free Survival Carcinoma, Non-Small-Cell Lung Disease Progression null --- T790M ---

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 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 Progression Free Survival Carcinoma, Non-Small-Cell Lung Disease Progression null --- T790M --- --- T790M ---



HPO Nodes


HPO:
Non-small cell lung carcinoma
Genes 3
TP53 TP53 BAP1