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

Phase 2

Terminated

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.

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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Placebo plus erlotinib	placebo	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.
Ficlatuzumab plus erlotinib	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.
Ficlatuzumab plus erlotinib	Ficlatuzumab	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	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.

Primary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS)	Approximately 24 months	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

Name	Time	Method
Number of Participants With Adverse Events	Approximately 24 months	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.

Locations (47): UCSF Fresno
🇺🇸
Fresno, California, United States
Torrance Memorial Medical Center
🇺🇸
Redondo Beach, California, United States
Boca Raton Regional Hospital Lynn Cancer Institute
🇺🇸
Boca Raton, Florida, United States
University of Miami Sylvester Comprehensive Cancer Center Deerfield Beach
🇺🇸
Deerfield Beach, Florida, United States
Kaiser Permanente Hawaii
🇺🇸
Honolulu, Hawaii, United States
Cancer Center of Acadiana
🇺🇸
Lafayette, Louisiana, United States
Mayo Clinic
🇺🇸
Rochester, Minnesota, United States
Valley Medical Group
🇺🇸
Paramus, New Jersey, United States
Queens Hospital Cancer Center
🇺🇸
Jamaica, New York, United States
Aultman Hospital
🇺🇸
Canton, Ohio, United States
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UCSF Fresno
🇺🇸Fresno, California, United States