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

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ClinicalTrials.gov Identifier: NCT02134015
Recruitment Status : Terminated (Pre-defined criteria for continuation were not reached)
First Posted : May 8, 2014
Results First Posted : January 23, 2018
Last Update Posted : January 23, 2018
Sponsor:
Collaborator:
Parexel
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

Tracking Information
First Submitted Date  ICMJE April 8, 2014
First Posted Date  ICMJE May 8, 2014
Results First Submitted Date  ICMJE November 29, 2017
Results First Posted Date  ICMJE January 23, 2018
Last Update Posted Date January 23, 2018
Study Start Date  ICMJE March 2014
Actual Primary Completion Date November 11, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 22, 2017)
  • Part A: Progression Free Survival (PFS) in Heregulin-high Participants [ Time Frame: by trial termination (at 20 months) ]
    PFS is defined as the time from the date of randomization to the earlier of the dates of first objective documentation of radiographic disease progression (as per RECIST Version 1.1 per investigator assessment) or death resulting from any cause. Kaplan-Meier Estimate. Confidence interval (CI) for median was computed using the Brookmeyer-Crowley method. 80% confidence interval is included in the data table.
  • Part A: Progression Free Survival (PFS) in Heregulin-low Participants [ Time Frame: by trial termination (at 20 months) ]
    PFS is defined as the time from the date of randomization to the earlier of the dates of first objective documentation of radiographic disease progression (as per RECIST Version 1.1 per investigator assessment) or death resulting from any cause. Kaplan-Meier Estimate. Confidence interval (CI) for median was computed using the Brookmeyer-Crowley method. 80% confidence interval is included in the data table.
  • Part B: Overall Survival [ Time Frame: 4 years ]
    Percentage of participants still alive at the end of Part B
Original Primary Outcome Measures  ICMJE
 (submitted: May 6, 2014)
Overall survival (OS) assessed every 12 weeks [ Time Frame: every 12 weeks from date of randomization until date of death ]
Patients will be contacted every 12 weeks from date of randomization until date of death to track overall survival assessed up to 4 years.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 22, 2017)
  • Part A: Overall Survival in HRG High Participants [ Time Frame: by trial termination (at 20 months) ]
    Key secondary efficacy endpoint: Percentage of participants who survived for the length of the trial
  • Part A: Key Secondary Efficacy Endpoint: Overall Survival in HRG Low Participants [ Time Frame: by trial termination (at 20 months) ]
    Key secondary efficacy endpoint: Percentage of participants who survived for the length of the trial
  • Part B: Key Secondary Efficacy Endpoint: PFS, TTD [ Time Frame: 4 years ]
    PFS is defined as the time from the date of randomization to the earlier of the dates of first objective documentation of radiographic disease progression (TTD, as per RECIST Version 1.1 per investigator assessment) or death resulting from any cause.
  • Part A: Objective Response Rate (ORR) in HRG High Participants [ Time Frame: by trial termination (at 20 months) ]
    Key secondary efficacy endpoint: Objective response is defined as percentage of participants achieving complete response (CR) or partial response (PR) Denominator for percentages is the number of subjects with measurable disease in the full analysis set. The best overall response is the best response [in the order of CR, PR, stable disease (SD), and progressive disease (PD)] among all overall responses recorded from the start of treatment until the subject withdraws from the study. If there is no post-baseline tumor assessment or all post-baseline tumor assessments with overall response being Inevaluable captured in the CRF, the best overall response is classified as Inevaluable.
  • Part A: Objective Response Rate (ORR) in HRG Low Participants [ Time Frame: by trial termination (at 20 months) ]
    Key secondary efficacy endpoint: Objective response is defined as percentage of participants achieving complete response or partial response Denominator for percentages is the number of subjects with measurable disease in the full analysis set. The best overall response is the best response (in the order of CR, PR, SD, and PD) among all overall responses recorded from the start of treatment until the subject withdraws from the study. If there is no post-baseline tumor assessment or all post-baseline tumor assessments with overall response being Inevaluable captured in the CRF, the best overall response is classified as Inevaluable.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 6, 2014)
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 ]
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Patritumab in Combination With Erlotinib in Subjects With Locally Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC). (HER3-Lung)
Official Title  ICMJE 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
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Lung Cancer
  • Non-small Cell Lung Cancer
Intervention  ICMJE
  • Drug: Patritumab
    Infusion of Patritumab (loading dose of 18 mg/kg, followed by 9 mg/kg every 3 weeks)
    Other Name: U3-1287
  • Drug: Erlotinib
    Oral erlotinib 150 mg/day
  • Drug: Placebo
    Placebo infusion every 3 weeks
    Other Name: Matching Placebo
Study Arms  ICMJE
  • Experimental: Placebo + erlotinib
    Placebo infusion every 3 weeks and oral erlotinib 150 mg/day
    Interventions:
    • Drug: Erlotinib
    • Drug: Placebo
  • 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
    Interventions:
    • Drug: Patritumab
    • Drug: Erlotinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 22, 2017)
145
Original Estimated Enrollment  ICMJE
 (submitted: May 6, 2014)
780
Actual Study Completion Date  ICMJE November 11, 2016
Actual Primary Completion Date November 11, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Canada,   Czechia,   Germany,   Hungary,   Italy,   Poland,   Spain,   United Kingdom,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT02134015
Other Study ID Numbers  ICMJE U31287-A-U301
2013-004371-12 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Daiichi Sankyo, Inc.
Study Sponsor  ICMJE Daiichi Sankyo, Inc.
Collaborators  ICMJE Parexel
Investigators  ICMJE
Study Director: Global Clinical Leader Daiichi Sankyo, Inc.
PRS Account Daiichi Sankyo, Inc.
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP