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A Phase 2, Study of Ficlatuzumab Plus Erlotinib vs. Placebo Plus Erlotinib in Subjects With Previously Untreated Metastatic, EGFR-mutated NSCLC and BDX004 Positive Label (FOCAL)

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ClinicalTrials.gov Identifier: NCT02318368
Recruitment Status : Terminated (Sponsor's decision)
First Posted : December 17, 2014
Last Update Posted : January 9, 2018
Sponsor:
Collaborator:
Biodesix, Inc.
Information provided by (Responsible Party):
AVEO Pharmaceuticals, Inc.

Brief Summary:
Phase 2 multicenter, controlled, randomized, double-blind study to evaluate the efficacy and safety of ficlatuzumab versus placebo when administered with erlotinib in subjects with previously untreated metastatic EGFR-mutated NSCLC and BDX004 Positive Label.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: Ficlatuzumab Drug: Erlotinib Drug: placebo Phase 2

Detailed Description:

This is a Phase 2 multicenter, controlled, randomized, double-blind study to evaluate the efficacy and safety of ficlatuzumab versus placebo when administered with erlotinib in subjects with previously untreated metastatic EGFR-mutated NSCLC and BDX004 Positive Label.

Prior to screening, subjects will have tested positive for a sensitizing EGFR mutation to determine eligibility for treatment with erlotinib. During screening, subject serum samples will be tested using the investigational companion diagnostic (BDX004) test. Only those subjects who have a BDX004 Positive Label will be enrolled. Subject randomization will be stratified by EGFR mutation type and smoking status (ever versus never smokers). Subjects will be designated as never smokers if they have smoked less than 100 cigarettes in their lifetime. Radiographic tumor assessment, to include CT or MRI of chest and abdomen, will be performed every 4 weeks for the first 8 cycles, and every 8 weeks thereafter, using the same imaging modality per subject. Safety assessments will be performed on an ongoing basis.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Randomized, Double-blind Study of Ficlatuzumab Plus Erlotinib Versus Placebo Plus Erlotinib in Subjects Who Have Previously Untreated Metastatic, EGFR-mutated Non-small Cell Lung Cancer (NSCLC) and BDX004 Positive Label
Actual Study Start Date : November 2014
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ficlatuzumab plus erlotinib
150 mg Erlotinib orally once daily starting on Day 1 of Cycle 1 with 20 mg/kg Ficlatuzumab administered intravenously once every 2 weeks on Day 1 and Day 15 of each 28 day cycle.
Drug: Ficlatuzumab
Other Name: Ficla

Drug: Erlotinib
Other Name: Erlotinib hydrochloride

Active Comparator: Placebo plus erlotinib
150 mg Erlotinib orally once daily starting on Day 1 of Cycle 1 with Placebo administered intravenously once every 2 weeks on Day 1 and Day 15 of each 28 day cycle.
Drug: Erlotinib
Other Name: Erlotinib hydrochloride

Drug: placebo



Primary Outcome Measures :
  1. Progression Free Survival is defined as the time from the date of randomization to the date of the first objective documentation of radiographic disease progression or death due to any cause, whichever occurs first. [ Time Frame: Approximately 24 months ]

Secondary Outcome Measures :
  1. Overall Survival as measured from the date of randomization to the date of death. [ Time Frame: Approximately 48 months ]
  2. Objective response rate is defined as a CR or PR according to RECIST v.1.1 recorded from randomization until disease progression or death due to any cause. [ Time Frame: Approximately 24 months ]
  3. Disease control rate is defined as CR, PR, or SD at least 4 cycles (16 weeks) according to the RECIST v.1.1 recorded in the time period between randomization and disease progression or death to any cause. [ Time Frame: Approximately 24 months ]
  4. Safety and tolerability, as defined by number of AEs. [ Time Frame: Approximately 24 months ]
  5. PK parameters of ficlatuzumab and erlotinib will be calculated from serum and plasma levels in the blood over time. [ Time Frame: Cycle 1 day 1 & day 15, Cycle 2 day 1 & day 15, Cycle 3 day 1 & day 15, Cycle 4 day 1 & day 15, Cycle 5 day 1, Cycle 7 day 1, Cycle 9 day 1, Cycle 11 day 1 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Histologically and/or cytologically confirmed primary diagnosis of Stage IV NSCLC (according to American Joint Committee on Cancer [AJCC] 7th edition lung cancer staging criteria).
  • Measurable disease according to RECIST v.1.1.
  • An EGFR exon 19 deletion and/or an exon 21 (L858R) substitution mutation.
  • BDX004 Positive Label.
  • Have received no prior systemic chemotherapy, immunotherapy, targeted therapy, or biologic therapy for metastatic NSCLC. Subjects may have previously been treated with postoperative adjuvant chemotherapy for early stage lung cancer or chemo radiotherapy for locally advanced disease provided this was completed at least 6 months prior to enrollment. No prior EGFR TKI therapy is allowed for any stage of NSCLC.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Exclusion Criteria
  • History of severe allergic or anaphylactic reactions or hypersensitivity to recombinant proteins or excipients in the investigational agent or erlotinib.
  • History of known brain metastases.
  • Prior treatment with any other investigational drug or biologic agent within 5 half lives prior to randomization, or any investigational device within 2 weeks prior to randomization.
  • Any unresolved toxicity from previous radiation therapy.
  • Significant cardiovascular disease, including:

    • Echocardiogram (ECHO) or multiple gated acquisition (MUGA) showing left ventricular ejection fraction of less than 55%.
    • Cardiac failure New York Heart Association class III or IV.
    • Myocardial infarction, severe or unstable angina within 6 months prior to randomization.
    • History of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation).
    • Significant thrombotic or embolic events within 3 months prior to randomization (significant thrombotic or embolic events include but are not limited to stroke or transient ischemic attack).
    • Any uncontrolled or severe cardiovascular disease.
  • History of prior malignancy within 3 years prior to randomization (except for adequately treated non-melanoma skin cancer, carcinoma in situ of the breast or cervix, superficial bladder cancer, or early stage prostate cancer, without evidence of recurrence).
  • Radiographic evidence of interstitial lung disease.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02318368


  Show 47 Study Locations
Sponsors and Collaborators
AVEO Pharmaceuticals, Inc.
Biodesix, Inc.
Investigators
Study Director: Michael N Needle, MD AVEO Pharmaceuticals, Inc.

Responsible Party: AVEO Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02318368     History of Changes
Other Study ID Numbers: AV-299-14-206
First Posted: December 17, 2014    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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