Clinical Trials /

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

NCT02355431

Description:

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.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Withdrawn

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Itacitinib in Combination With Erlotinib in Non Small Cell Lung Cancer Patients With Epidermal Growth Factor Receptor (EGFR) Activating Mutations
  • Official Title: A Randomized, Double-blind Phase 2 Study of Itacitinib in Combination With Erlotinib Versus Erlotinib Alone in Subjects With Stage IIIB/ IV or Recurrent Non-Small Cell Lung Cancer (NSCLC) Whose Tumors Have Epidermal Growth Factor Receptor (EGFR) Activating Mutations

Clinical Trial IDs

  • ORG STUDY ID: INCB 39110-205
  • NCT ID: NCT02355431

Conditions

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

Interventions

DrugSynonymsArms
ItacitinibINCB039110Itacitinib plus erlotinib
erlotinibTarceva®Itacitinib plus erlotinib
placeboPlacebo plus erlotinib

Purpose

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.

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.
    

Trial Arms

NameTypeDescriptionInterventions
Itacitinib plus erlotinibExperimental
  • Itacitinib
  • erlotinib
Placebo plus erlotinibActive Comparator
  • erlotinib
  • placebo

Eligibility Criteria

        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:

          -  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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure: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 Frame:Baseline through Day 21
Safety Issue:
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 therapy

Secondary Outcome Measures

Measure:Part 2: Objective Response
Time Frame:Baseline through end of study. Approximately 31 months.
Safety Issue:
Description:Objective response determined by radiographic disease assessments per RECIST (v1.1), by investigator assessment
Measure:Part 2: Duration of Response
Time Frame:Baseline through end of study. Approximately 31 months.
Safety Issue:
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: 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.
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Withdrawn
Lead Sponsor:Incyte Corporation

Trial Keywords

  • EGFR
  • mutation

Last Updated

March 8, 2019