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)

 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, loc...
Cancer () - Lung
Howard (Jack) West, M.D.
Swedish Cancer Institute

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.
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