The purpose of this study is to determine if Itacitinib in combination with erlotinib is safe and effective in the treatment of nonsquamous non-small cell lung cancer (NSCLC) that is Stage IIIB/Stage IV or recurrent whose tumors have EGFR activating mutations.
Name: ItacitinibDescription: tablets to be administered by mouth once daily at dose selected from safety run-in phaseType: Drug
Itacitinib plus erlotinib
Name: erlotinibDescription: 150 mg tablets administered by mouth once daily at total daily dose of 150 mgType: Drug
Itacitinib plus erlotinib Placebo plus erlotinib
Name: placeboDescription: matching placebo tablets to be administered by mouth at dose selected from safety run-in phaseType: Drug
Placebo plus erlotinib
Description: Subjects will take erlotinib daily and begin dosing with itacitinib once daily (QD) on Cycle 1, Day 1. The safety and tolerability of the regimen will be assessed during the first 21 days of therapyMeasure: Part 1: Determination of the dose of itacitinib that is safe and tolerable in combination with erlotinib as measured by the number of dose-limiting toxicities (DLTs) observed in the evaluation cohort. Time: Baseline through Day 21
Description: PFS is defined as the time from randomization until the earliest date of disease progression determined by investigator assessment of objective radiographic disease assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause if sooner.Measure: Part 2: Progression-free survival (PFS) Time: Randomization to disease progression, or death due to any cause if sooner. Approximately 23 months.
Description: Objective response determined by radiographic disease assessments per RECIST (v1.1), by investigator assessmentMeasure: Part 2: Objective Response Time: Baseline through end of study. Approximately 31 months.
Description: Duration of response determined by radiographic disease assessments per RECIST (v1.1), by investigator assessment Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.Measure: Part 2: Duration of Response Time: Baseline through end of study. Approximately 31 months.
There are 2 SNPs
Inclusion Criteria: - Histologically or cytologically confirmed diagnosis of nonsquamous NSCLC that is Stage IIIB, Stage IV, or recurrent (including Stage II). - Documented evidence of an activating mutation in EGFR in tumor samples (exon 19 deletions or point mutation L858R in exon 21 or point mutations at codon 719). --- L858R ---
Exclusion Criteria: - Known presence of the T790M mutation in EGFR in tumor samples - Candidates for curative radiation therapy or surgery. --- T790M ---