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

NCT02355431 | Withdrawn Phase 2 DMC

• 1 other identifier: INCB 39110-205
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

EGFR; mutation

Outcome Measures

Primary Outcomes (3)

• 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

  Baseline through Day 21

• Part 2: Overall Survival (OS)

  Randomization until death. Approximately 31 months.

• 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.

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

Secondary Outcomes (3)

• Part 2: Objective Response

  Baseline through end of study. Approximately 31 months.

• Part 2: Duration of Response

  Baseline through end of study. Approximately 31 months.

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

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

Study Arms (2)

Itacitinib plus erlotinib

EXPERIMENTAL

Drug: Itacitinib; Drug: erlotinib

Placebo plus erlotinib

ACTIVE COMPARATOR

Drug: erlotinib; Drug: placebo

Interventions

Itacitinib DRUG

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

Also known as: INCB039110

Itacitinib plus erlotinib

erlotinib DRUG

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

Also known as: Tarceva®

Itacitinib plus erlotinib; Placebo plus erlotinib

placebo DRUG

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

Placebo plus erlotinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (1)

Unknown Facility

Ogden, Utah, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

itacitinib; INCB039110; Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Gerard T. Kennealey, M.D.

  Incyte Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2015
• First Posted: February 4, 2015
• Study Start: December 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: March 8, 2019

Record last verified: 2019-03

Locations

US (1)