Clinical Trials /

Study of Patritumab in Combination With Erlotinib in Subjects With Locally Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC). (HER3-Lung)

NCT02134015

Description:

1. Part A: Subjects will receive Patritumab or placebo with erlotinib. 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.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Terminated

Phase:

Phase 3

Trial Eligibility

Document

Study of <span class="go-doc-concept go-doc-intervention">Patritumab</span> in Combination With <span class="go-doc-concept go-doc-intervention">Erlotinib</span> in Subjects With Locally Advanced or Metastatic Non-Small-Cell <span class="go-doc-concept go-doc-disease">Lung Cancer</span> (<span class="go-doc-concept go-doc-disease">NSCLC</span>). (HER3-Lung)

Title

  • Brief Title: Study of Patritumab in Combination With Erlotinib in Subjects With Locally Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC). (HER3-Lung)
  • Official Title: Phase 3, Randomized, Placebo-Controlled, Double-Blind, Multi-Center, Two-Part Study of Patritumab (U3-1287) In Combination With Erlotinib in EGFR Wild-type Subjects With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) Who Have Progressed on at Least One Prior Systemic Therapy
  • Clinical Trial IDs

    NCT ID: NCT02134015

    ORG ID: U31287-A-U301

    Trial Conditions

    Lung Cancer

    Non Small Cell Lung Cancer.

    Trial Interventions

    Drug Synonyms Arms
    Patritumab Patritumab + erlotinib
    erlotinib: Patritumab + erlotinib, Placebo + erlotinib
    Placebo Placebo + erlotinib

    Trial Purpose

    1. Part A: Subjects will receive Patritumab or placebo with erlotinib. 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.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    Patritumab + erlotinib Experimental Infusion of Patritumab (loading dose of 18 mg/kg, followed by 9 mg/kg every 3 weeks) and oral erlotinib 150 mg/day Patritumab, erlotinib:
    Placebo + erlotinib Experimental Placebo infusion every 3 weeks and oral erlotinib 150 mg/day erlotinib:, Placebo

    Eligibility Criteria

    Inclusion Criteria:

    1. Must be greater or equal to 20 years of age

    2. Must have cytologically or histologically confirmed NSCLC with either:

    - Metastatic disease (Stage IV) OR

    - Stage IIIB disease not amenable to surgery or curative intent.

    Note: It is permissible to use either AJCC Version 6.0 or the AJCC Version 7.0
    staging system. For sites that use AJCC Version 7.0, T4M0 patients with other
    ipsilateral nodules and N0-N2 are still eligible.

    3. 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.

    4. Must have received one or two prior lines of systemic chemotherapy for advanced or
    metastatic disease, one of which must be a platinum-doublet therapy.

    5. Must have disease progression or recurrence documented by radiographic assessment
    following treatment after last chemotherapy or chemoradiation regimen (completed
    within the previous 12 months).

    6. Must have available recent (before treatment start) or archival tumor specimen.

    7. Must have measurable disease for Part A, measurable disease or non-measurable disease
    for Part B

    8. Must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

    9. Must have adequate hematological function

    10. Must have adequate renal function

    11. Must have adequate hepatic function

    12. Agreement to use effective contraception while on treatment and for at least 6 months
    after end of treatment

    13. Must have provided informed consent for study participation.

    Exclusion Criteria:

    1. Lung adenocarcinoma with an Anaplastic Lymphoma Kinase (ALK) gene rearrangement

    2. Left ventricular ejection fraction (LVEF) less than 45%

    3. Prior EGFR-targeted regimen, anti-HER2, anti-HER3, or anti-HER4 therapy

    4. 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

    5. History of corneal disease

    6. History of interstitial lung disease (ILD)

    7. Clinically active brain metastases

    8. Uncontrolled hypertension

    9. Clinically significant ECG changes

    10. Clinically significant (in the opinion of the Investigator) ascites or pleural
    effusion requiring chronic medical intervention

    11. Myocardial infarction within 1 year before enrollment, symptomatic congestive heart
    failure, unstable angina, or unstable cardiac arrhythmia requiring medication

    12. Treatment with anticancer therapy, antibody-based therapy, retinoid therapy, or
    hormonal therapy within 4 weeks before study drug treatment

    13. Therapeutic radiation therapy or major surgery within 4 weeks before study drug
    treatment; or palliative radiation within 2 weeks before study drug treatment

    14. Participation in clinical drug trials within 4 weeks

    15. Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals, known
    human immunodeficiency virus (HIV) infection, or active hepatitis B or C infection.

    16. History of hypersensitivity to any of the study drugs or to any excipients.

    Minimum Eligible Age: 20 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Overall survival (OS) assessed every 12 weeks

    Secondary Outcome Measures

    Progression free survival (PFS)

    Trial Keywords

    Carcinoma

    Non-Small-Cell Lung

    Lung Neoplasms

    Bronchogenic

    Bronchial Neoplasms

    Respiratory Tract Neoplasms

    Thoracic Neoplasms

    Neoplasms by Site

    Neoplasms

    Lung Diseases

    Respiratory Tract Diseases

    Erlotinib

    Therapeutic Uses

    Pharmacologic Actions

    Molecular Mechanisms of Pharmacological Action