Back to resultsA 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)
Primary Purpose
Non-small Cell Lung Cancer
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Ficlatuzumab
Erlotinib
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Non-small Cell Lung Cancer
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.
Sites / Locations
- UCSF Fresno
- Torrance Memorial Medical Center
- Boca Raton Regional Hospital Lynn Cancer Institute
- University of Miami Sylvester Comprehensive Cancer Center Deerfield Beach
- Kaiser Permanente Hawaii
- Cancer Center of Acadiana
- Mayo Clinic
- Valley Medical Group
- Queens Hospital Cancer Center
- Aultman Hospital
- Gabrail Cancer Center
- UPMC Cancer Center Cancer
- Huntsman Cancer Institute
- Chris O'Brien Lifehouse
- North Coast Cancer Institute
- Concord Repatriation General Hospital
- Townsville Hospital
- Icon Cancer Care
- Princess Alexandra Hospital
- Flinders Medical Centre
- Eastern Health
- Frankston Hospital
- Ballarat Oncology and Haematology
- Tuen Mun Hospital
- Queen Mary Hospital
- AO G.Rummo
- Policlinico S.Orsola Malpighi
- Istituti Ospitalieri di Cremona - Oncologia
- U.O.C. Oncologia
- IRCCS Ospedale S.Raffaele
- Fondazione Salvatore Maugeri
- IRCCS Istituto Clinico Humanitas
- Ospedale Treviglio-Caravaggio
- Korea University Guro Hospital
- Chungbuk National University Hospital
- Chonnam National University Hwasun Hospital
- Severance Hospital, Yonsei Uni
- Samsung Medical Center
- John Hopkins Singapore International Medical Center
- National Cancer Centre
- Chung Shan Medical University
- China Medical University Hospital
- National Cheng Kung University
- National Taiwan University Hospital
- Taipei Veterans General Hospital
- Taipei Medical University
- Chang Gung Medical Foundation
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ficlatuzumab plus erlotinib
Placebo plus erlotinib
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Progression Free Survival (PFS)
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
Number of Participants With Adverse Events
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.
Full Information
NCT ID
NCT02318368
First Posted
December 9, 2014
Last Updated
October 20, 2020
Sponsor
AVEO Pharmaceuticals, Inc.
Collaborators
Biodesix, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02318368
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
Acronym
FOCAL
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Terminated
Why Stopped
Sponsor's decision
Study Start Date
November 2014 (Actual)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AVEO Pharmaceuticals, Inc.
Collaborators
Biodesix, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ficlatuzumab plus erlotinib
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo plus erlotinib
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ficlatuzumab
Other Intervention Name(s)
Ficla
Intervention Type
Drug
Intervention Name(s)
Erlotinib
Other Intervention Name(s)
Erlotinib hydrochloride
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS)
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.
Time Frame
Approximately 24 months
Secondary Outcome Measure Information:
Title
Number of Participants With Adverse Events
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.
Time Frame
Approximately 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael N Needle, MD
Organizational Affiliation
AVEO Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
UCSF Fresno
City
Fresno
State/Province
California
ZIP/Postal Code
93701
Country
United States
Facility Name
Torrance Memorial Medical Center
City
Redondo Beach
State/Province
California
ZIP/Postal Code
90277
Country
United States
Facility Name
Boca Raton Regional Hospital Lynn Cancer Institute
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
University of Miami Sylvester Comprehensive Cancer Center Deerfield Beach
City
Deerfield Beach
State/Province
Florida
ZIP/Postal Code
33442
Country
United States
Facility Name
Kaiser Permanente Hawaii
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96819
Country
United States
Facility Name
Cancer Center of Acadiana
City
Lafayette
State/Province
Louisiana
ZIP/Postal Code
70503
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Valley Medical Group
City
Paramus
State/Province
New Jersey
ZIP/Postal Code
07652
Country
United States
Facility Name
Queens Hospital Cancer Center
City
Jamaica
State/Province
New York
ZIP/Postal Code
11432
Country
United States
Facility Name
Aultman Hospital
City
Canton
State/Province
Ohio
ZIP/Postal Code
44710
Country
United States
Facility Name
Gabrail Cancer Center
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
UPMC Cancer Center Cancer
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Chris O'Brien Lifehouse
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
North Coast Cancer Institute
City
Coffs Harbour
State/Province
New South Wales
ZIP/Postal Code
2450
Country
Australia
Facility Name
Concord Repatriation General Hospital
City
Concord
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
Facility Name
Townsville Hospital
City
Douglas
State/Province
Queensland
ZIP/Postal Code
4814
Country
Australia
Facility Name
Icon Cancer Care
City
Southport
State/Province
Queensland
ZIP/Postal Code
4215
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Wolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Flinders Medical Centre
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
5043
Country
Australia
Facility Name
Eastern Health
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Frankston Hospital
City
Frankston
State/Province
Victoria
ZIP/Postal Code
3199
Country
Australia
Facility Name
Ballarat Oncology and Haematology
City
Wendouree
State/Province
Victoria
ZIP/Postal Code
3355
Country
Australia
Facility Name
Tuen Mun Hospital
City
Tuen Mun
State/Province
N.T
Country
Hong Kong
Facility Name
Queen Mary Hospital
City
Pok Fu Lam
Country
Hong Kong
Facility Name
AO G.Rummo
City
Benevento
ZIP/Postal Code
82100
Country
Italy
Facility Name
Policlinico S.Orsola Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Istituti Ospitalieri di Cremona - Oncologia
City
Cremona
ZIP/Postal Code
26100
Country
Italy
Facility Name
U.O.C. Oncologia
City
Lucca
ZIP/Postal Code
55100
Country
Italy
Facility Name
IRCCS Ospedale S.Raffaele
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Fondazione Salvatore Maugeri
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
IRCCS Istituto Clinico Humanitas
City
Rozzano MI
ZIP/Postal Code
20089
Country
Italy
Facility Name
Ospedale Treviglio-Caravaggio
City
Treviglio BG
ZIP/Postal Code
24047
Country
Italy
Facility Name
Korea University Guro Hospital
City
Guro-gu
State/Province
Seoul
ZIP/Postal Code
152703
Country
Korea, Republic of
Facility Name
Chungbuk National University Hospital
City
Chungcheongbuk-do
ZIP/Postal Code
362-711
Country
Korea, Republic of
Facility Name
Chonnam National University Hwasun Hospital
City
Jeonnam
ZIP/Postal Code
519-763
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei Uni
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
John Hopkins Singapore International Medical Center
City
Central Singapore
ZIP/Postal Code
308433
Country
Singapore
Facility Name
National Cancer Centre
City
Singapore
ZIP/Postal Code
169610
Country
Singapore
Facility Name
Chung Shan Medical University
City
Taichung
ZIP/Postal Code
40201
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
National Cheng Kung University
City
Tainan
ZIP/Postal Code
70403
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei City
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei City
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Taipei Medical University
City
Taipei
ZIP/Postal Code
11696
Country
Taiwan
Facility Name
Chang Gung Medical Foundation
City
Taoyuan City
ZIP/Postal Code
333
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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
We'll reach out to this number within 24 hrs