SNPMiner Trials by Shray Alag


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Report for Clinical Trial NCT02655536

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase II, Open Label, Multicenter Study of Bevacizumab in Combination With Erlotinib Versus Erlotinib Alone in Patients With EGFR Mutant Non-small Cell Lung Cancer Who Have Brain Metastases

This is an open-label, randomized, multicenter phase II study conducting in 3 medical centers in Asia. Patients will receive erlotinib in combination with bevacizumab or erlotinib alone. This study will enroll EGFR-mutant NSCLC patients who have asymptomatic brain metastases. The primary objective is to compare the systemic progression-free survival (PFS) to bevacizumab plus erlotinib versus erlotinib alone in patients with EGFR mutant NSCLC who have asymptomatic brain metastases.

NCT02655536 Carcinoma, Non-Small-Cell Lung Brain Neoplasms
MeSH:Carcinoma, Non-Small-Cell Lung Brain Neoplasms
HPO:Brain neoplasm Non-small cell lung carcinoma

2 Interventions

Name: Bevacizumab plus erlotinib

Description: Bevacizumab will be administered at a dose of 15 mg/kg on day 1 of every 3 weeks cycle by IV infusion erlotinib will be give at 150mg orally every day for 21 days of every 3 weeks cycle
Type: Drug
Group Labels: 1

bevacizumab plus erlotinib

Name: Erlotinib

Description: erlotinib will be give at 150mg orally every day for 21 days of every 3 weeks cycle
Type: Drug
Group Labels: 1

erlotinib


Primary Outcomes

Description: The PFS will be evaluated from date of randomization until the date of documented progression or the date of death from any cause, whichever came first.

Measure: Progression-free survival

Time: The PFS will be evaluated per RECIST 1.1 criteria every 6 weeks for the first 12 months and then every 12 weeks up to 36 months.

Secondary Outcomes

Measure: overall survival

Time: The survival will be assessed from date of randomization until the date of death from any cause. The survival will be assessed every 3 weeks up to 36 months.

Description: The response rate will be evaluated from date of randomization until the date of documented progression or the date of death from any cause, whichever came first.

Measure: overall response rate

Time: The response rate will be evaluated per RECIST 1.1 criteria every 6 weeks for the first 12 months and then every 12 weeks up to 36 months.

Description: The Time-to- CNS progression will be evaluated from date of randomization until the date of documented CNS progression.

Measure: Time-to-central nervous system (CNS) progression

Time: Time-to-central nervous system(CNS) progression will be evaluated per RECIST 1.1 criteria every 6 weeks for the first 12 months and then every 12 weeks up to 36 months.

Description: The Time-to-extra-CNS progression will be evaluated from date of randomization until the date of documented extra-CNS progression.

Measure: Time to extra-CNS progression

Time: Time to extra-CNS progression will be evaluated per RECIST 1.1 criteria every 6 weeks for the first 12 months and then every 12 weeks up to 36 months.

Description: The PFS-2 will be evaluated from date of randomization until the date of second documented progression or the date of death from any cause, whichever came first.

Measure: The PFS-2 in patients in patients with CNS progression only

Time: The PFS-2 will be evaluated per RECIST 1.1 criteria every 6 weeks for the first 12 months and then every 12 weeks up to 36 months.

Description: Time to neurological symptom will be assessed from date of randomization until the dated of documented progression of neurological symptom.

Measure: Time to neurological symptom progression

Time: Time to neurological symptom progression will be evaluated every 3 weeks up to 36 months.

Measure: Number of participants with treatment-related adverse events as assessed by CTCAE version 4.03

Time: Treatment-related adverse events will be evaluated from date of randomization until 30 days after discontinuation of the trial. It will be evaluated every 3 weeks up to 36 months.

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 L858R

- A tumor harboring an EGFR mutation known to be associated with erlotinib sensitivity (exon 19 deletion and L858R) - Documented brain metastases. --- L858R ---

Patients will be stratified according to the EGFR L858R mutation and the EGFR exon 19 deletion mutation. --- L858R ---



HPO Nodes


HPO: