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
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer||Drug: Ficlatuzumab Drug: Erlotinib Drug: placebo||Phase 2|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
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.
Other Name: Ficla
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.
Other Name: Erlotinib hydrochloride
- 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 ]
- 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 ]
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
|Study Director:||Michael N Needle, MD||AVEO Pharmaceuticals, Inc.|