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Report for Clinical Trial NCT02318368

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase 2, Multicenter, Randomized, Double-blind Study of Ficlatuzumab Plus Erlotinib Versus Placebo Plus Erlotinib in Subjects Who Have Previously Untreated Metastatic, EGFR-mutated Non-small Cell Lung Cancer (NSCLC) and BDX004 Positive Label

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.

NCT02318368 Non-small Cell Lung Cancer
MeSH:Lung Neoplasms Carcinoma, Non-Small-Cell Lung
HPO:Neoplasm of the lung Non-small cell lung carcinoma

3 Interventions

Name: Ficlatuzumab

Type: Drug
Group Labels: 1

Ficlatuzumab plus erlotinib

Name: Erlotinib

Type: Drug
Group Labels: 2

Ficlatuzumab plus erlotinib Placebo plus erlotinib

Name: placebo

Type: Drug
Group Labels: 1

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: