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WithdrawnPhase 2NCT02355431
Official study title

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

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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedItacitinib and erlotinib

Plus 1 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · EGFR · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Mar 8, 2019 · Source: ClinicalTrials.gov

Is enrollment open?Withdrawn

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Incyte Corporation

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Incyte Corporation
Interventions being studied
Drug: Itacitinib; Drug: erlotinib; Drug: placebo
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Disease setting
Metastatic or stage IV→Recurrent or relapsed→
Biomarkers
EGFR→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.
Reasons someone may not be able to joinExclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Study locationOgden, Utah

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 8, 2019. Always confirm current availability with the study team.

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