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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Lung Cancer, Non-small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT02134015

Run by

Daiichi Sankyo

People needed

145

Starts

2014-03-01

Expected to finish

2016-11-11

Last updated by the study team

2018-01-23

Who can join

Age: 20 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Must be greater or equal to 20 years of age
• 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.
• 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 chemotherapy 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
• Agreement to use effective contraception while on treatment and for at least 6 months after end of treatment
• Must have provided informed consent for study participation.

You may not qualify if…

• Lung adenocarcinoma with an Anaplastic Lymphoma Kinase (ALK) gene rearrangement
• Left ventricular ejection fraction (LVEF) less than 45%
• Prior EGFR-targeted regimen, anti-HER2, anti-HER3, or anti-HER4 therapy
• 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
• History of corneal disease
• History of interstitial lung disease (ILD)
• Clinically active brain metastases
• Uncontrolled hypertension
• Clinically significant ECG changes
• Clinically significant (in the opinion of the Investigator) ascites or pleural effusion requiring chronic medical intervention
• Myocardial infarction within 1 year before enrollment, symptomatic congestive heart failure, unstable angina, or unstable cardiac arrhythmia requiring medication
• Treatment with anticancer therapy, antibody-based therapy, retinoid therapy, or hormonal therapy within 4 weeks before study drug treatment
• Therapeutic radiation therapy or major surgery within 4 weeks before study drug treatment; or palliative radiation within 2 weeks before study drug treatment
• Participation in clinical drug trials within 4 weeks
• Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals, known human immunodeficiency virus (HIV) infection, or active hepatitis B or C infection.
• History of hypersensitivity to any of the study drugs or to any excipients.

Where it is running

• Study site — Duarte, California, United States
• Study site — La Verne, California, United States
• Study site — Los Angeles, California, United States
• Study site — San Francisco, California, United States
• Study site — Port Saint Lucie, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Chicago, Illinois, United States
• Study site — Maywood, Illinois, United States
• Study site — Goshen, Indiana, United States
• Study site — Louisville, Kentucky, United States
• Study site — Grand Rapids, Michigan, United States
• Study site — Saint Cloud, Minnesota, United States
• Study site — St Louis, Missouri, United States
• Study site — Las Vegas, Nevada, United States
• Study site — Columbus, Ohio, United States
• Study site — Bend, Oregon, United States
• Study site — Portland, Oregon, United States
• Study site — Redmond, Oregon, United States
• Study site — Chattanooga, Tennessee, United States
• Study site — Knoxville, Tennessee, United States
• Study site — Nashville, Tennessee, United States
• Study site — Dallas, Texas, United States
• Study site — Salt Lake City, Utah, United States
• Study site — Arlington, Virginia, United States
• Study site — Glendale, Arizona, United States

Full record on ClinicalTrials.gov

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