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WithdrawnNCT02355431Updated Mar 8, 2019

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

A Phase 2 interventional study of Itacitinib and erlotinib in Solid Tumors and Hematologic Malignancy and NSCLC (Non-small Cell Lung Carcinoma), sponsored by Incyte Corporation. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-08.

Sponsored by Incyte Corporation · Phase 2, Interventional, and Treatment

Why this study was withdrawn
Study withdrawn before enrolling first patient
Phase
Phase 2
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

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.

Read the detailed description

The study consists of an open-label, safety run-in to confirm the safety of Itacitinibin combination with erlotinib in subjects with nonsquamous non-small cell lung cancer (NSCLC) that is Stage IIIB, Stage IV, or recurrent whose tumors have EGFR activating mutations. Subjects in the safety run-in will receive open-label Itacitinib and erlotinib.

In the second part of the study, subjects will be enrolled and randomized to receive erlotinib (open-label) and either Itacitinib or placebo in a blinded manner. The dose of Itacitinib administered will be determined from the data produced in the safety run-in phase.

Treatment will consist of repeating 21-day cycles. Subjects will take erlotinib tablets daily and Itacitinib/placebo will be self-administered daily during the entire cycle.

02

Conditions studied

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

Keywords

  • EGFR
  • mutation
03

In context

Carcinoma, Non-Small-Cell Lung

6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

Incyte Corporation is the lead sponsor of 286 studies on the registry; 37 are open to participants now.

Of its 144 completed or terminated interventional studies of FDA-regulated products, 93 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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).

  • A mGPS of 1 or 2 as defined below:

    • Criteria: C-reactive protein >10 mg/L AND albumin ≥35 g/L Score-1
    • Criteria: C-reactive protein >10 mg L AND albumin \<35 g/L Score-2
  • Radiographically measurable or evaluable disease.
  • Life expectancy of at least 12 weeks.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
  • Adequate renal, hepatic, and bone marrow function demonstrated by protocol-specified laboratory parameters at the screening visit.

Exclusion criteria

Exclusion Criteria:

  • Known presence of the T790M mutation in EGFR in tumor samples
  • Candidates for curative radiation therapy or surgery.
  • Previous systemic chemotherapy for advanced disease, including EGFR inhibitor therapy, except subjects who received 1 cycle of chemotherapy while waiting to receive EGFR results, who may enroll provided that 21 days have elapsed from end of chemotherapy to the day to the baseline radiographic measurement prior to Cycle 1 Day 1.
  • Distinct or suspected, or history of, pulmonary fibrosis or ILD.
  • Current or previous other malignancy within 2 years of study entry, except cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive indolent or Stage I malignancy without sponsor approval.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Itacitinib plus erlotinib

    Drug: Itacitinib · Drug: erlotinib

  • Active comparator
    Placebo plus erlotinib

    Drug: erlotinib · Drug: placebo

Interventions

  • DrugItacitinib

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

    Also known as: INCB039110

  • Drugerlotinib

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

    Also known as: Tarceva®

  • Drugplacebo

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

06

What researchers measure

Primary outcomes

  1. 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.

    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 therapy

    Time frame: Baseline through Day 21

  2. Part 2: Overall Survival (OS)

    Time frame: Randomization until death. Approximately 31 months.

  3. Part 2: Progression-free survival (PFS)

    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.

    Time frame: Randomization to disease progression, or death due to any cause if sooner. Approximately 23 months.

Secondary outcomes

  1. Part 2: Objective Response

    Objective response determined by radiographic disease assessments per RECIST (v1.1), by investigator assessment

    Time frame: Baseline through end of study. Approximately 31 months.

  2. Part 2: Duration of Response

    Duration of response determined by radiographic disease assessments per RECIST (v1.1), by investigator assessment Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

    Time frame: Baseline through end of study. Approximately 31 months.

  3. Part 2: Safety and tolerability of the treatment regimens assessed by a summary of adverse events and clinical laboratory assessments.

    Time frame: Baseline through approximately 30 days post treatment discontinuation. Assessed after approximately 31 months.

07

Study locations

1 site
  • Ogden, Utah, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 8, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02355431
Lead sponsor
Incyte Corporation
Responsible party
Sponsor
First posted
Feb 4, 2015
Start date
Dec 2014
Primary completion
Sep 2015
Completion
Sep 2015
Last update
Mar 8, 2019

Study contacts

Gerard T. Kennealey, M.D.
study director · Incyte Corporation

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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