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Report for Clinical Trial NCT02759614

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Randomized, Open-label, Controlled Multicenter Study to Compare Bevacizumab in Combination With Erlotinib Versus Erlotinib Alone in Chinese NSCLC Patients Harbouring Activating EGFR Mutations(Artemis)

This is a randomized, open-label, controlled, multicenter, Phase III study. Patients will be randomly assigned to treatment group (1:1) through a dynamic randomization process with use of the following stratification factors: sex (female/male), disease stage (stage IIIb vs. stage IV vs. recurrence), and EGFR gene mutation (exon 19 deletion vs. exon 21 L858R).

NCT02759614 NSCLC
MeSH:Carcinoma, Non-Small-Cell Lung
HPO:Non-small cell lung carcinoma

2 Interventions

Name: Bevacizumab

Description: Bevacizumab15mg/kg by intravenous drip infusion on day 1 of a 21-day (within 3 days) cycle and Erlotinib orally once daily at 150mg/day
Type: Drug
Group Labels: 1

Bevacizumab and Erlotinib

Name: Erlotinib

Description: Erlotinib 150mg, orally once a day
Type: Drug
Group Labels: 2

Bevacizumab and Erlotinib Erlotinib


Primary Outcomes

Description: To evaluate the efficacy of bevacizumab combined with erlotinib compared with erlotinib alone in patients with NSCLC harbouring activating EGFR mutations, as measured by independent review committee assessed progression-free survival using RECIST v1.1

Measure: Progression-free survival (PFS) by IRC

Time: The primary PFS analysis will be performed when approximately 224 PFS events (disease progression or death, whichever occurs first) have occurred, which is estimated to occur at approximately 18 months after enrollment of the last patient.

Secondary Outcomes

Description: To evaluate the efficacy of bevacizumab combined with erlotinib compared with erlotinib alone in patients with NSCLC harbouring activating EGFR mutations, as measured by investigators assessed progression-free survival using RECIST v1.1

Measure: Progression-free survival (PFS) by investigator using RECIST v1.1

Time: The primary PFS analysis will be performed when approximately 224 PFS events (disease progression or death, whichever occurs first) have occurred, which is estimated to occur at approximately 18 months after enrollment of the last patient.

Description: To evaluate the efficacy of bevacizumab combined with erlotinib compared with erlotinib alone in patients with NSCLC harbouring activating EGFR mutations, as measured by independent review committee assessed objective response rate using RECIST v1.1

Measure: Objective response rate (ORR) by IRC using RECIST v1.1

Time: baseline overall tumor assessment can be performed up to 28 days prior to randomization. Post-baseline assessment will be performed every six weeks until 1st disease progression, through study completion, an average of 2 years.

Description: To evaluate the efficacy of bevacizumab combined with erlotinib compared with erlotinib alone in patients with NSCLC harbouring activating EGFR mutations, as measured by investigators assessed objective response rate using RECIST v1.1

Measure: Objective response rate (ORR) by investigator using RECIST v1.1

Time: baseline overall tumor assessment can be performed up to 28 days prior to randomization. Post-baseline assessment will be performed every six weeks until 1st disease progression, through study completion, an average of 2 years.

Description: Disease control rate (DCR) will be analyzed using similar method as objective response rate.

Measure: Disease control rate (DCR) by IRC using RECIST v1.1

Time: That is expected to be approximately 57 months.

Description: Disease control rate (DCR) will be analyzed using similar method as objective response rate.

Measure: Disease control rate (DCR) by investigator using RECIST v1.1

Time: That is expected to be approximately 57 months.

Description: Duration of response(DOR) will be analyzed using similar method as objective response rate.

Measure: Duration of response(DOR) by IRC using RECIST v1.1

Time: That is expected to be approximately 57 months.

Description: Duration of response(DOR) will be analyzed using similar method as objective response rate.

Measure: Duration of response(DOR) by investigator using RECIST v1.1

Time: That is expected to be approximately 57 months.

Description: To evaluate the efficacy of bevacizumab combined with erlotinib compared with erlotinib alone in patients with NSCLC harbouring activating EGFR mutations, as measured by investigators assessed overall survival .

Measure: Overall survival(OS)

Time: That is expected to be approximately 57 months.

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There are 2 SNPs

SNPs


1 L858R

Patients will be randomly assigned to treatment group (1:1) through a dynamic randomization process with use of the following stratification factors: sex (female/male), disease stage (stage IIIb vs. stage IV vs. recurrence), and EGFR gene mutation (exon 19 deletion vs. exon 21 L858R). --- L858R ---

An exon 19 deletion mutation or exon 21 L858R mutation has been found in high-sensitivity EGFR mutation tests by PCR using tumor tissue centrally confirmed. --- L858R ---


2 T790M

2. A positive result for the exon 20 T790M mutation from any high-sensitivity EGFR mutation test such as digital PCR using tumor tissue or cells. --- T790M ---



HPO Nodes


HPO: