Overview

This trial is active, not recruiting.

Conditions lung cancer, non-small cell lung cancer
Treatments patritumab, erlotinib:, placebo
Phase phase 3
Targets EGFR, HER3
Sponsor Daiichi Sankyo Inc.
Collaborator Parexel
Start date March 2014
End date June 2018
Trial size 724 participants
Trial identifier NCT02134015, U31287-A-U301

Summary

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.

United States Illinois and Texas
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(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
Infusion of Patritumab (loading dose of 18 mg/kg, followed by 9 mg/kg every 3 weeks)
erlotinib:
Oral erlotinib 150 mg/day.
(Experimental)
Placebo infusion every 3 weeks and oral erlotinib 150 mg/day
erlotinib:
Oral erlotinib 150 mg/day.
placebo
Placebo infusion every 3 weeks

Primary Outcomes

Measure
Overall survival (OS) assessed every 12 weeks
time frame: every 12 weeks from date of randomization until date of death

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 20 years old.

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.

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Daiichi Sankyo Inc..