Trial record 1 of 1 for:    U31287-A-U301
Previous Study | Return to List | Next Study

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Daiichi Sankyo Inc.
Sponsor:
Collaborator:
Parexel
Information provided by (Responsible Party):
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT02134015
First received: April 8, 2014
Last updated: August 20, 2014
Last verified: August 2014
  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.

Condition Intervention Phase
Lung Cancer
Non Small Cell Lung Cancer.
Drug: Patritumab
Drug: erlotinib:
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:
  • Overall survival (OS) assessed every 12 weeks [ Time Frame: every 12 weeks from date of randomization until date of death ] [ Designated as safety issue: Yes ]
    Patients will be contacted every 12 weeks from date of randomization until date of death to track overall survival assessed up to 4 years.


Secondary Outcome Measures:
  • Progression free survival (PFS) [ Time Frame: every 6 weeks for the first 24 weeks after randomization and then every 12 weeks until date of death or up to 4 years ] [ Designated as safety issue: No ]
    Patients will be evaluated for these endpoints every 6 weeks for the first 24 weeks after randomization and then every 12 weeks until date of death or up to 4 years.


Estimated Enrollment: 780
Study Start Date: March 2014
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Patritumab + erlotinib
Infusion of Patritumab (loading dose of 18 mg/kg, followed by 9 mg/kg every 3 weeks) and oral erlotinib 150 mg/day
Drug: Patritumab
Infusion of Patritumab (loading dose of 18 mg/kg, followed by 9 mg/kg every 3 weeks)
Drug: erlotinib:
Oral erlotinib 150 mg/day.
Experimental: Placebo + erlotinib
Placebo infusion every 3 weeks and oral erlotinib 150 mg/day
Drug: erlotinib:
Oral erlotinib 150 mg/day.
Drug: Placebo
Placebo infusion every 3 weeks

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Must be greater or equal to 20 years of age
  2. Must have histologically confirmed NSCLC with either:

    • Metastatic disease (Stage IV) OR
    • Stage IIIB disease not amenable to surgery or curative intent.
  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 anti-cancer therapy 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 (any grade) 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02134015

Locations
United States, California
Recruiting
Duarte, California, United States
Contact: Koczywas    626-256-4673 ext 63155      
United States, Florida
Recruiting
Port St. Lucie, Florida, United States
Contact: Iannotti    (772) 353-4899      
United States, Nevada
Recruiting
Las Vegas, Nevada, United States
Contact: Braiteh, MD    702-952-3400    fadi.braiteh@usoncology.com   
United States, Tennessee
Recruiting
Chattanooga, Tennessee, United States
Contact: Gandhi, MD    423-622-2337      
Recruiting
Knoxville, Tennessee, United States
Contact: DeVore, MD    865-934-2670      
United States, Utah
Recruiting
Salt Lake City, Utah, United States
Contact: Akerley    (801) 585-0303      
United States, Virginia
Recruiting
Fairfax, Virginia, United States
Contact: Spira, MD    703-280-5390    alexander.spira@usoncology.com   
United States, Washington
Recruiting
Seattle, Washington, United States
Contact: West    206-386-2424    howard.west@swedish.org   
Sponsors and Collaborators
Daiichi Sankyo Inc.
Parexel
  More Information

No publications provided

Responsible Party: Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier: NCT02134015     History of Changes
Other Study ID Numbers: U31287-A-U301
Study First Received: April 8, 2014
Last Updated: August 20, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Daiichi Sankyo Inc.:
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

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Erlotinib
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014