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
Name: Erlotinib
Name: placebo
Description: 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.
Measure: Progression Free Survival (PFS) Time: Approximately 24 monthsDescription: To evaluate Safety and tolerability of ficlatuzumab plus erlotinib versus placebo plus erlotinib in subjects who have previously untreated metastatic EGFR-mutated NSCLC and a BDX004 Positive Label.
Measure: Number of Participants With Adverse Events Time: Approximately 24 monthsAllocation: Randomized
Parallel Assignment
There is one SNP
- An EGFR exon 19 deletion and/or an exon 21 (L858R) substitution mutation. --- L858R ---