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Withdrawn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

INCB039110 in Combination With <span class="go-doc-concept go-doc-intervention">Erlotinib</span> in Non Small Cell <span class="go-doc-concept go-doc-disease">Lung Cancer</span> Patients With Epidermal Growth Factor Receptor (<span class="go-doc-concept go-doc-biomarker">EGFR</span>) Activating <span class="go-doc-concept go-doc-keyword">Mutations</span>

Title

  • Brief Title: INCB039110 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 INCB039110 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

    NCT ID: NCT02355431

    ORG ID: INCB 39110-205

    Trial Conditions

    Carcinoma

    Non Small Cell Lung Cancer

    Trial Interventions

    Drug Synonyms Arms
    INCB039110 INCB039110 plus erlotinib
    erlotinib Tarceva INCB039110 plus erlotinib, Placebo plus erlotinib
    placebo Placebo plus erlotinib

    Trial Purpose

    The purpose of this study is to determine if INCB039110 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 INCB039110 in
    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 INCB039110 and erlotinib.

    In the second part of the study, subjects will be enrolled and randomized to receive
    erlotinib (open-label) and either INCB039110 or placebo in a blinded manner. The dose of
    INCB039110 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 INCB039110/placebo will be self-administered daily during the entire cycle.

    Trial Arms

    Name Type Description Interventions
    INCB039110 plus erlotinib Experimental INCB039110, erlotinib
    Placebo plus erlotinib Active 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.

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Part 1: Determination of the dose of INCB039110 that is safe and tolerable in combination with erlotinib as measured by the number of dose-limiting toxicities (DLTs) observed in the evaluation cohort.

    Part 2: Overall Survival (OS)

    Part 2: Progression-free survival (PFS)

    Secondary Outcome Measures

    Part 2: Objective Response

    Part 2: Duration of Response

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

    Trial Keywords

    EGFR

    mutation