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
1 L858R
- An EGFR exon 19 deletion and/or an exon 21 (L858R) substitution mutation. --- L858R ---
HPO Nodes
HPO:Neoplasm of the lung
Genes 43
WT1 KRAS SLC22A18 STK11 IRF1 AKT1 C11ORF95 PRKN PPP2R1B ERBB2 TRPV3 TSC1 POU6F2 TSC2 EWSR1 RELA KEAP1 REST DIS3L2 SFTPA2 GPC3 MBTPS2 LMNA PTEN BRAF BRCA2 EGFR RB1 TRIP13 PDGFRB TERT SFTPC PIK3CA TRIM28 DICER1 MAP3K8 HPGD SLCO2A1 H19 TP53 NOTCH3 BAP1 WRN hr>Non-small cell lung carcinoma
Genes 2
TP53 BAP1 hr>