ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 5 of 22 for:    INCB039110

INCB039110 in Combination With Erlotinib in Non Small Cell Lung Cancer Patients With Epidermal Growth Factor Receptor (EGFR) Activating Mutations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02355431
Recruitment Status : Withdrawn (Study withdrawn before enrolling first patient)
First Posted : February 4, 2015
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Solid Tumors and Hematologic Malignancy NSCLC (Non-small Cell Lung Carcinoma) Drug: INCB039110 Drug: erlotinib Drug: placebo Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : December 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: INCB039110 plus erlotinib Drug: INCB039110
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
Other Name: Tarceva®
Active Comparator: Placebo plus erlotinib Drug: erlotinib
150 mg tablets administered by mouth once daily at total daily dose of 150 mg
Other Name: Tarceva®
Drug: placebo
matching placebo tablets to be administered by mouth at dose selected from safety run-in phase



Primary Outcome Measures :
  1. 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. [ Time Frame: Baseline through Day 21 ]
    Subjects will take erlotinib daily and begin dosing with INCB039110 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

  2. Part 2: Overall Survival (OS) [ Time Frame: Randomization until death. Approximately 31 months. ]
  3. Part 2: Progression-free survival (PFS) [ Time Frame: Randomization to disease progression, or death due to any cause if sooner. Approximately 23 months. ]
    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.


Secondary Outcome Measures :
  1. Part 2: Objective Response [ Time Frame: Baseline through end of study. Approximately 31 months. ]
    Objective response determined by radiographic disease assessments per RECIST (v1.1), by investigator assessment

  2. Part 2: Duration of Response [ Time Frame: Baseline through end of study. Approximately 31 months. ]
    Duration of response determined by radiographic disease assessments per RECIST (v1.1), by investigator assessment Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

  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. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02355431


Locations
United States, Utah
Ogden, Utah, United States
Sponsors and Collaborators
Incyte Corporation
Investigators
Study Director: Gerard T. Kennealey, M.D. Incyte Corporation

Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT02355431     History of Changes
Other Study ID Numbers: INCB 39110-205
First Posted: February 4, 2015    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018

Keywords provided by Incyte Corporation:
EGFR
mutation

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Erlotinib Hydrochloride
Mitogens
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Mitosis Modulators