Overview

This trial is active, not recruiting.

Condition non-small cell lung cancer
Treatments ficlatuzumab, erlotinib, placebo
Phase phase 2
Targets c-MET, EGFR
Sponsor AVEO Pharmaceuticals, Inc.
Collaborator Biodesix Inc.
Start date November 2014
End date January 2017
Trial size 86 participants
Trial identifier NCT02318368, AV-299-14-206

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.

United States California, Minnesota, and Utah
Other Countries Singapore

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Experimental)
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.
ficlatuzumab
erlotinib
(Active Comparator)
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.
erlotinib
placebo

Primary Outcomes

Measure
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 Outcomes

Measure
Overall Survival as measured from the date of randomization to the date of death.
time frame: Approximately 48 months
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
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
Safety and tolerability, as defined by number of AEs.
time frame: Approximately 24 months
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

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by AVEO Pharmaceuticals, Inc..