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.
Terminated
Phase 2
NCT ID: NCT02318368
ORG ID: AV-299-14-206
Non-small Cell Lung Cancer
| Drug | Synonyms | Arms |
|---|---|---|
| Ficlatuzumab | Ficlatuzumab plus erlotinib | |
| Erlotinib | Ficlatuzumab plus erlotinib, Placebo plus erlotinib | |
| placebo | Placebo plus erlotinib |
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.
| Name | Type | Description | Interventions |
|---|---|---|---|
| Ficlatuzumab plus erlotinib | 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 |
| Placebo plus 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 |
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.
Minimum Eligible Age: 18 Years
Maximum Eligible Age: N/A
Eligible Gender: Both
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.
Overall Survival as measured from the date of randomization to the date of death.
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.
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.
Safety and tolerability, as defined by number of AEs.
PK parameters of ficlatuzumab and erlotinib will be calculated from serum and plasma levels in the blood over time.
