Description:
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.
Title
- Brief Title: 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
- 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
Clinical Trial IDs
- ORG STUDY ID:
AV-299-14-206
- NCT ID:
NCT02318368
Conditions
- Non-small Cell Lung Cancer
Interventions
| Drug | Synonyms | Arms |
|---|
| Ficlatuzumab | Ficla | Ficlatuzumab plus erlotinib |
| Erlotinib | Erlotinib hydrochloride | Ficlatuzumab plus erlotinib |
| placebo | | Placebo plus erlotinib |
Purpose
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.
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.
Trial Arms
| 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. | |
| 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. | |
Eligibility 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.
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Progression Free Survival (PFS) |
| Time Frame: | Approximately 24 months |
| Safety Issue: | |
| Description: | 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. |
Secondary Outcome Measures
| Measure: | Number of Participants With Adverse Events |
| Time Frame: | Approximately 24 months |
| Safety Issue: | |
| Description: | To evaluate Safety and tolerability of ficlatuzumab plus erlotinib versus placebo plus erlotinib in subjects who have previously untreated metastatic EGFR-mutated NSCLC and a BDX004 Positive Label. |
Details
| Phase: | Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Terminated |
| Lead Sponsor: | AVEO Pharmaceuticals, Inc. |
Last Updated
October 22, 2020
