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
- Conditions
- Non-small Cell Lung Cancer
- Interventions
- Registration Number
- NCT02318368
- Lead Sponsor
- AVEO Pharmaceuticals, Inc.
- 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
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 10
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- 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.
Trial Locations
- Locations (47)
Frankston Hospital
🇦🇺Frankston, Victoria, Australia
IRCCS Ospedale S.Raffaele
🇮🇹Milano, Italy
IRCCS Istituto Clinico Humanitas
🇮🇹Rozzano MI, Italy
National Cheng Kung University
🇨🇳Tainan, Taiwan
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
Ballarat Oncology and Haematology
🇦🇺Wendouree, Victoria, Australia
Townsville Hospital
🇦🇺Douglas, Queensland, Australia
Icon Cancer Care
🇦🇺Southport, Queensland, Australia
Flinders Medical Centre
🇦🇺Bedford Park, South Australia, Australia
Eastern Health
🇦🇺Box Hill, Victoria, Australia
Princess Alexandra Hospital
🇦🇺Wolloongabba, Queensland, Australia
AO G.Rummo
🇮🇹Benevento, Italy
Policlinico S.Orsola Malpighi
🇮🇹Bologna, Italy
Istituti Ospitalieri di Cremona - Oncologia
🇮🇹Cremona, Italy
U.O.C. Oncologia
🇮🇹Lucca, Italy
Fondazione Salvatore Maugeri
🇮🇹Pavia, Italy
Ospedale Treviglio-Caravaggio
🇮🇹Treviglio BG, Italy
Severance Hospital, Yonsei Uni
🇰🇷Seoul, Korea, Republic of
Korea University Guro Hospital
🇰🇷Guro-gu, Seoul, Korea, Republic of
Chonnam National University Hwasun Hospital
🇰🇷Jeonnam, Korea, Republic of
Chungbuk National University Hospital
🇰🇷Chungcheongbuk-do, Korea, Republic of
National Taiwan University Hospital
🇨🇳Taipei City, Taiwan
Taipei Veterans General Hospital
🇨🇳Taipei City, Taiwan
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
John Hopkins Singapore International Medical Center
🇸🇬Central Singapore, Singapore
National Cancer Centre
🇸🇬Singapore, Singapore
Chang Gung Medical Foundation
🇨🇳Taoyuan City, Taiwan
China Medical University Hospital
🇨🇳Taichung, Taiwan
Taipei Medical University
🇨🇳Taipei, Taiwan
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Chung Shan Medical University
🇨🇳Taichung, Taiwan
UPMC Cancer Center Cancer
🇺🇸Pittsburgh, Pennsylvania, United States
Huntsman Cancer Institute
🇺🇸Salt Lake City, Utah, United States
UCSF Fresno
🇺🇸Fresno, California, United States
Torrance Memorial Medical Center
🇺🇸Redondo Beach, California, United States
Kaiser Permanente Hawaii
🇺🇸Honolulu, Hawaii, United States
Cancer Center of Acadiana
🇺🇸Lafayette, Louisiana, United States
Aultman Hospital
🇺🇸Canton, Ohio, United States
Queens Hospital Cancer Center
🇺🇸Jamaica, New York, United States
Valley Medical Group
🇺🇸Paramus, New Jersey, United States
Chris O'Brien Lifehouse
🇦🇺Camperdown, New South Wales, Australia
Gabrail Cancer Center
🇺🇸Canton, Ohio, United States
North Coast Cancer Institute
🇦🇺Coffs Harbour, New South Wales, Australia
Concord Repatriation General Hospital
🇦🇺Concord, New South Wales, Australia
Queen Mary Hospital
ðŸ‡ðŸ‡°Pok Fu Lam, Hong Kong
Tuen Mun Hospital
ðŸ‡ðŸ‡°Tuen Mun, N.T, Hong Kong