5547W-14 Daiichi U31287-A-U301 NSCLC

CRC 14015: Phase 3 Randomized, Placebo-Controlled, Double-blind, Multi-Center, Two-Part Study of Patritumab in Combination With Erlotinib in Subjects With Locally Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC). (HER3-Lung)

Type of Study
Cancer (Oncology) - Lung
Location
Swedish Cancer Institute
Short Description
 Purpose
  1. Part A: Subjects will receive Patritumab or placebo. Progression-free survival will be the primary outcome. Subjects will need to have Epidermal Growth Factor Receptor (EGFR) wild-type, locally advance or metastatic NSCLC and have their cancer progressed after at least one prior systemic anti-cancer therapy, available recent or archival tumor specimen and may not have had previous EGFR-targeted regimen, anti-HER2 (Human Epidermal Growth Factor Receptor 2), anti-HER3, or anti-HER4 therapy. Subjects may have high heregulin or low heregulin.
  2. Part B: Subjects will receive Patritumab or placebo with erlotinib. Overall survival will be the primary outcome. Subjects will need to have EGFR wild-type, locally advance or metastatic NSCLC and have their cancer progressed after at least one prior systemic anti-cancer therapy, available recent or archival tumor specimen and may not have had previous EGFR-targeted regimen, anti-HER2, anti-HER3, or anti-HER4 therapy. Only subjects with high heregulin will be enrolled.
Status
Open to Enrollment
Principal Investigator
Howard (Jack) West, M.D.
Eligibility Notes

Inclusion Criteria:
 

  • Must be greater or equal to 20 years of age
  • Must have histologically confirmed NSCLC with either:
    • Metastatic disease (Stage IV) OR
    • Stage IIIB disease not amenable to surgery or curative intent.
  • If tumor histology is adenocarcinoma, must have wild-type EGFR genotype as assessed by a validated assay that includes exon 19 deletion and exon 21 (L858R) substitution.
  • Must have received one or two prior lines of systemic anti-cancer therapy for advanced or metastatic disease, one of which must be a platinum-doublet therapy.
  • Must have disease progression or recurrence documented by radiographic assessment following treatment after last chemotherapy or chemoradiation regimen (completed within the previous 12 months).
  • Must have available recent (before treatment start) or archival tumor specimen.
  • Must have measurable disease for Part A, measurable disease or non-measurable disease for Part B
  • Must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Must have adequate hematological function
  • Must have adequate renal function
  • Must have adequate hepatic function
  • Must agree to use effective contraception while on treatment and for at least 6 months after end of treatment
  • Must not have lung adenocarcinoma with an Anaplastic Lymphoma Kinase (ALK) gene rearrangement
  • Must not have left ventricular ejection fraction (LVEF) less than 45%
  • Must not have received prior EGFR-targeted regimen, anti-HER2, anti-HER3, or anti-HER4 therapy
  • No history of other malignancies, except adequately treated non-melanoma skin cancer, curatively treated in-situ disease, or other solid tumors curatively treated with no evidence of disease for greater or equal to 5 years
  • No history of corneal disease
  • No history of interstitial lung disease (ILD)
  • No clinically active brain metastases
  • No uncontrolled hypertension
  • No clinically significant ECG changes
  • No clinically significant (any grade) ascites or pleural effusion requiring chronic medical intervention
  • No myocardial infarction within 1 year before enrollment, symptomatic congestive heart failure, unstable angina, or unstable cardiac arrhythmia requiring medication
  • No treatment with anticancer therapy, antibody-based therapy, retinoid therapy, or hormonal therapy within 4 weeks before study drug treatment
  • No therapeutic radiation therapy or major surgery within 4 weeks before study drug treatment; or palliative radiation within 2 weeks before study drug treatment
  • No participation in other clinical drug trials within 4 weeks
  • No uncontrolled infection requiring IV antibiotics, antivirals, or antifungals, known human immunodeficiency virus (HIV) infection, or active hepatitis B or C infection.
  • No history of hypersensitivity to any of the study drugs or to any excipients.
More Info Link
Additional information about the study summary and eligibility criteria may be viewed on the U.S. National Institutes of Health (NIH) website.
Phone
(206) 215-3086
Email
CancerResearch@swedish.org