SNPMiner Trials: Clinical Trial Report
Report for Clinical Trial NCT02318368
Developed by Shray Alag, 2019.
SNP Clinical Trial Gene
Phase 2 multicenter, controlled, randomized, double-blind study to evaluate the efficacy and
safety of ficlatuzumab versus placebo when administered with erlotinib in subjects with
previously untreated metastatic EGFR-mutated NSCLC and BDX004 Positive Label.
Name: Ficlatuzumab
Type: Drug
Ficlatuzumab plus erlotinib
Name: Erlotinib
Type: Drug
Ficlatuzumab plus erlotinib Placebo plus erlotinib
Name: placebo
Type: Drug
Placebo plus erlotinib
Primary Outcomes
Measure: Progression Free Survival is defined as the time from the date of randomization to the date of the first objective documentation of radiographic disease progression or death due to any cause, whichever occurs first.
Time: Approximately 24 months
Secondary Outcomes
Measure: Overall Survival as measured from the date of randomization to the date of death.
Time: Approximately 48 months
Measure: Objective response rate is defined as a CR or PR according to RECIST v.1.1 recorded from randomization until disease progression or death due to any cause.
Time: Approximately 24 months
Measure: Disease control rate is defined as CR, PR, or SD at least 4 cycles (16 weeks) according to the RECIST v.1.1 recorded in the time period between randomization and disease progression or death to any cause.
Time: Approximately 24 months
Measure: Safety and tolerability, as defined by number of AEs.
Time: Approximately 24 months
Measure: PK parameters of ficlatuzumab and erlotinib will be calculated from serum and plasma levels in the blood over time.
Time: Cycle 1 day 1 & day 15, Cycle 2 day 1 & day 15, Cycle 3 day 1 & day 15, Cycle 4 day 1 & day 15, Cycle 5 day 1, Cycle 7 day 1, Cycle 9 day 1, Cycle 11 day 1
Purpose: Treatment
Allocation: Randomized
Parallel Assignment
There is one SNP
SNPs
- An EGFR exon 19 deletion and/or an exon 21 (L858R) substitution mutation. --- L858R ---
HPO Nodes