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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02318368




Registration number
NCT02318368
Ethics application status
Date submitted
9/12/2014
Date registered
17/12/2014
Date last updated
9/01/2018

Titles & IDs
Public 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
Scientific 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
Secondary ID [1] 0 0
AV-299-14-206
Universal Trial Number (UTN)
Trial acronym
FOCAL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ficlatuzumab
Treatment: Drugs - Erlotinib
Treatment: Drugs - placebo

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.

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.


Treatment: Drugs: Ficlatuzumab


Treatment: Drugs: Erlotinib


Treatment: Drugs: placebo


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Approximately 24 months
Secondary outcome [1] 0 0
Overall Survival as measured from the date of randomization to the date of death.
Timepoint [1] 0 0
Approximately 48 months
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
Approximately 24 months
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
Approximately 24 months
Secondary outcome [4] 0 0
Safety and tolerability, as defined by number of AEs.
Timepoint [4] 0 0
Approximately 24 months
Secondary outcome [5] 0 0
PK parameters of ficlatuzumab and erlotinib will be calculated from serum and plasma levels in the blood over time.
Timepoint [5] 0 0
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

Eligibility
Key inclusion 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [2] 0 0
North Coast Cancer Institute - Coffs Harbour
Recruitment hospital [3] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [4] 0 0
Townsville Hospital - Douglas
Recruitment hospital [5] 0 0
Icon Cancer Care - Southport
Recruitment hospital [6] 0 0
Princess Alexandra Hospital - Wolloongabba
Recruitment hospital [7] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [8] 0 0
Eastern Health - Box Hill
Recruitment hospital [9] 0 0
Frankston Hospital - Frankston
Recruitment hospital [10] 0 0
Ballarat Oncology and Haematology - Wendouree
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [3] 0 0
2139 - Concord
Recruitment postcode(s) [4] 0 0
4814 - Douglas
Recruitment postcode(s) [5] 0 0
4215 - Southport
Recruitment postcode(s) [6] 0 0
4102 - Wolloongabba
Recruitment postcode(s) [7] 0 0
5043 - Bedford Park
Recruitment postcode(s) [8] 0 0
3128 - Box Hill
Recruitment postcode(s) [9] 0 0
3199 - Frankston
Recruitment postcode(s) [10] 0 0
3355 - Wendouree
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Hawaii
Country [4] 0 0
United States of America
State/province [4] 0 0
Louisiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Minnesota
Country [6] 0 0
United States of America
State/province [6] 0 0
New Jersey
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
Ohio
Country [9] 0 0
United States of America
State/province [9] 0 0
Pennsylvania
Country [10] 0 0
United States of America
State/province [10] 0 0
Utah
Country [11] 0 0
Hong Kong
State/province [11] 0 0
N.T
Country [12] 0 0
Hong Kong
State/province [12] 0 0
Pok Fu Lam
Country [13] 0 0
Italy
State/province [13] 0 0
Benevento
Country [14] 0 0
Italy
State/province [14] 0 0
Bologna
Country [15] 0 0
Italy
State/province [15] 0 0
Cremona
Country [16] 0 0
Italy
State/province [16] 0 0
Lucca
Country [17] 0 0
Italy
State/province [17] 0 0
Milano
Country [18] 0 0
Italy
State/province [18] 0 0
Pavia
Country [19] 0 0
Italy
State/province [19] 0 0
Rozzano MI
Country [20] 0 0
Italy
State/province [20] 0 0
Treviglio BG
Country [21] 0 0
Korea, Republic of
State/province [21] 0 0
Seoul
Country [22] 0 0
Korea, Republic of
State/province [22] 0 0
Chungcheongbuk-do
Country [23] 0 0
Korea, Republic of
State/province [23] 0 0
Jeonnam
Country [24] 0 0
Singapore
State/province [24] 0 0
Central Singapore
Country [25] 0 0
Singapore
State/province [25] 0 0
Singapore
Country [26] 0 0
Taiwan
State/province [26] 0 0
Taichung
Country [27] 0 0
Taiwan
State/province [27] 0 0
Tainan
Country [28] 0 0
Taiwan
State/province [28] 0 0
Taipei City
Country [29] 0 0
Taiwan
State/province [29] 0 0
Taipei
Country [30] 0 0
Taiwan
State/province [30] 0 0
Taoyuan City

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AVEO Pharmaceuticals, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Biodesix, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02318368
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael N Needle, MD
Address 0 0
AVEO Pharmaceuticals, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02318368