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Itacitinib in Combination With Erlotinib in Non Small Cell Lung Cancer Patients With Epidermal Growth Factor Receptor (EGFR) Activating Mutations

NCT02355431 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2019-03-08

No results posted yet for this study

Summary

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.

Conditions

  • Solid Tumors and Hematologic Malignancy
  • NSCLC (Non-small Cell Lung Carcinoma)

Interventions

DRUG

Itacitinib

tablets to be administered by mouth once daily at dose selected from safety run-in phase

DRUG

erlotinib

150 mg tablets administered by mouth once daily at total daily dose of 150 mg

DRUG

placebo

matching placebo tablets to be administered by mouth at dose selected from safety run-in phase

Sponsors & Collaborators

Principal Investigators

  • Gerard T. Kennealey, M.D. · Incyte Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2015-09-30
Completion
2015-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02355431 on ClinicalTrials.gov