Non-small Cell Lung CancerPhase 2FOCALNCT02318368
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
A Phase 2 study testing Ficlatuzumab and Erlotinib in people with Non-small Cell Lung Cancer, run by AVEO Pharmaceuticals, Inc. at 47 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Ficlatuzumab and Erlotinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 47 sitesin 7 countries
- Study dates
- Nov 2014to Jan 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 19Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
47 sites in 7 countries.
47 sites in 7 countries
United States13 sites
Boca Raton Regional Hospital Lynn Cancer Institute
Boca Raton, Florida, 33486
Aultman Hospital
Canton, Ohio, 44710
Gabrail Cancer Center
Canton, Ohio, 44718
University of Miami Sylvester Comprehensive Cancer Center Deerfield Beach
Deerfield Beach, Florida, 33442
UCSF Fresno
Fresno, California, 93701
Kaiser Permanente Hawaii
Honolulu, Hawaii, 96819
Queens Hospital Cancer Center
Jamaica, New York, 11432
Cancer Center of Acadiana
Lafayette, Louisiana, 70503
Valley Medical Group
Paramus, New Jersey, 07652
UPMC Cancer Center Cancer
Pittsburgh, Pennsylvania, 15232
Torrance Memorial Medical Center
Redondo Beach, California, 90277
Mayo Clinic
Rochester, Minnesota, 55905
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
Australia10 sites
Flinders Medical Centre
Bedford Park, South Australia, 5043
Eastern Health
Box Hill, Victoria, 3128
Chris O'Brien Lifehouse
Camperdown, New South Wales, 2050
North Coast Cancer Institute
Coffs Harbour, New South Wales, 2450
Concord Repatriation General Hospital
Concord, New South Wales, 2139
Townsville Hospital
Douglas, Queensland, 4814
Frankston Hospital
Frankston, Victoria, 3199
Icon Cancer Care
Southport, Queensland, 4215
Ballarat Oncology and Haematology
Wendouree, Victoria, 3355
Princess Alexandra Hospital
Wolloongabba, Queensland, 4102
Italy8 sites
AO G.Rummo
Benevento, 82100
Policlinico S.Orsola Malpighi
Bologna, 40138
Istituti Ospitalieri di Cremona - Oncologia
Cremona, 26100
U.O.C. Oncologia
Lucca, 55100
IRCCS Ospedale S.Raffaele
Milan, 20132
Fondazione Salvatore Maugeri
Pavia, 27100
IRCCS Istituto Clinico Humanitas
Rozzano MI, 20089
Ospedale Treviglio-Caravaggio
Treviglio BG, 24047
Taiwan7 sites
Chung Shan Medical University
Taichung, 40201
China Medical University Hospital
Taichung, 40447
National Cheng Kung University
Tainan, 70403
National Taiwan University Hospital
Taipei, 100
Taipei Veterans General Hospital
Taipei, 11217
Taipei Medical University
Taipei, 11696
Chang Gung Medical Foundation
Taoyuan City, 333
South Korea5 sites
Chungbuk National University Hospital
Chungcheongbuk-do, 362-711
Korea University Guro Hospital
Guro-gu, Seoul, 152703
Chonnam National University Hwasun Hospital
Jeonnam, 519-763
Severance Hospital, Yonsei Uni
Seoul, 120-752
Samsung Medical Center
Seoul, 135-710
Hong Kong2 sites
Queen Mary Hospital
Pok Fu Lam
Tuen Mun Hospital
Tuenmen, N.T
Singapore2 sites
John Hopkins Singapore International Medical Center
Central Singapore, 308433
National Cancer Centre
Singapore, 169610
About this study
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
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.
Read the 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.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Ficlatuzumab, Erlotinib, placebo
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FiclatuzumabDrug
Also called Ficla
ErlotinibDrug
Also called Erlotinib hydrochloride
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| Ficlatuzumab plus erlotinib | Experimental | 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. Receives: Drug: Ficlatuzumab; Drug: Erlotinib |
| Placebo plus erlotinib | Active comparator | 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. Receives: Drug: Erlotinib; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Approximately 24 months
Secondary outcomes (1)
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.
Measured: Approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2014 (estimated)
- Study startNov 2014
- Primary completionJan 2017
- Study completionJan 2017
Why it stopped: Sponsor's decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- AVEO Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biodesix, Inc.
- Responsible party
- Sponsor
- Investigators
- Michael N Needle, MD, Study director, AVEO Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02318368
- Sponsor's protocol ID
- AV-299-14-206
- Acronym
- FOCAL
- Status last verified
- Oct 2020
- First submitted
- 9 Dec 2014
- Last updated
- 22 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02318368
- Acronym / sponsor ID
- FOCAL / AV-299-14-206
- Conditions
- Non-small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor's decision
- Enrolment
- 10 participants (actual)
- Lead sponsor
- AVEO Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Biodesix, Inc.
- Study start
- Nov 2014 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 17 Dec 2014 (estimated)
- Results
- Posted 22 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ficlatuzumab plus erlotinib | Experimental | Drug: Ficlatuzumab, Drug: Erlotinib150 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 | Active comparator | Drug: Erlotinib, Drug: placebo150 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FiclatuzumabAlso: Ficla | Drug | Ficlatuzumab plus erlotinib |
| ErlotinibAlso: Erlotinib hydrochloride | Drug | Ficlatuzumab plus erlotinib, Placebo plus erlotinib |
| placebo | Drug | Placebo plus erlotinib |
Primary outcome
Progression Free Survival (PFS)
Time frame: 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.
1 secondary outcome
Number of Participants With Adverse Events
Time frame: Approximately 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael N Needle, MD study director
AVEO Pharmaceuticals, Inc.
47 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ficlatuzumab and Erlotinib in people with Non-small Cell Lung Cancer, run by AVEO Pharmaceuticals, Inc. at 47 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in United States, Australia, Italy, Taiwan, South Korea and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) (time frame: Approximately 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.