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Adenocarcinoma of the LungPhase 2NCT01218516

A Safety and Efficacy Study of Farletuzumab in Participants With Adenocarcinoma of the Lung

A Phase 2 study testing Farletuzumab, Carboplatin and Paclitaxel in people with Adenocarcinoma of the Lung, run by Morphotek at 93 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The primary objective of this study is to compare the effect of farletuzumab versus placebo in combination with either a platinum agent (carboplatin) with paclitaxel or a platinum agent (carboplatin or cisplatin) with pemetrexed followed by farletuzumab or placebo on investigator-assessed progression free survival… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Adenocarcinoma of the Lung
What is being tested?
Farletuzumab, Carboplatin and Paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
130 participants
Where
93 sitesin 8 countries
Study dates
27 Jun 2011to 1 Nov 2013
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 or cytologically confirmed adenocarcinoma of the lung classified as stage IV
  • Confirmed folate receptor-alpha (FRA) expression by immunohistochemistry (IHC)
  • Measurable disease with at least one unidimensionally measurable lesion according to RECIST criteria version 1.1 by computed tomography (CT) or magnetic resonance imaging (MRI) scans (CT or MRI scans must have been performed within 30 days prior to the first dose of farletuzumab or placebo)
  • Must have received no prior chemotherapy, radiation therapy or surgery with curative intent for adenocarcinoma of the lung

Who cannot join

  • Participants who have had previous chemotherapy for adenocarcinoma of the lung
  • Prior surgery with curative intent for adenocarcinoma of the lung
  • Prior radiotherapy for adenocarcinoma of the lung. (Prior treatment with local radiotherapy for symptom control [i.e., palliative radiation with non-curative intent] is permitted)

Trial locations and contacts

93 sites in 8 countries.

93 sites in 8 countries

United States54 sites

  • Christus Saint Frances, Cabrini Hospital, Cabrini Cancer Center

    Alexandria, Louisiana, 71301

  • Texas Oncology - Bedford

    Bedford, Texas, 76022

  • National Cancer Institute

    Bethesda, Maryland, 20892

  • St. Luke's Cancer Center Associates

    Bethlehem, Pennsylvania, 18015

  • Providence Health System

    Beverly Hills, California, 90210-5501

  • Center for Hematology-Oncology

    Boca Raton, Florida, 33486

  • University Hematology Oncology, Inc.

    Centralia, Illinois, 62801

  • Ironwood Cancer and Research Center

    Chandler, Arizona, 85224

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

  • Maryland Oncology Hematology, P.A.

    Columbia, Maryland, 21044

  • Medical Specialists of the Palm Beaches

    Deerfield Beach, Florida, 33441

  • Rocky Mountain Cancer Centers, LLP

    Denver, Colorado, 80218-1237

  • Englewood Hospital and Medical Center

    Englewood, New Jersey, 07631

  • Willamette Valley Cancer Institute and Research Center

    Eugene, Oregon, 97401

  • Deaconess Clinic Downtown

    Evansville, Indiana, 47713

  • Virginia Cancer Specialists, PC

    Fairfax, Virginia, 22031

  • Detroit Clinical Research Center

    Farmington Hills, Michigan, 48336

  • Broward General Medical Center

    Fort Lauderdale, Florida, 33316

  • Cancer Care Associates of Fresno Medical Group, Inc.

    Fresno, California, 93720

  • University of Texas Medical Branch

    Galveston, Texas, 77555

  • Gettysburg Cancer Center

    Gettysburg, Pennsylvania, 17325

  • Medical Oncology Hematology

    Gilroy, California, 95020

  • Arizona Center for Hematology Oncology

    Glendale, Arizona, 85306-4666

  • Cancer Team Bellin Health

    Green Bay, Wisconsin, 54313

  • California Cancer Care, Inc.

    Greenbrae, California, 94904

  • Kentucky Cancer Center

    Hazard, Kentucky, 41701

  • Houston Cancer Institute

    Houston, Texas, 77055

  • Queens Hospital Center

    Jamaica, New York, 11432

  • Moores University of California San Diego Cancer Center

    La Jolla, California, 92093

  • Wilshire Medical Oncology Group

    La Verne, California, 91750

  • Cancer Care of North Florida

    Lake City, Florida, 32024

  • Baptist Health System, Inc.

    Lexington, Kentucky, 40503

  • Glendale Adventist Medical Center

    Los Angeles, California, 90025

  • Hematology and Oncology Specialists, LLC

    Metairie, Louisiana, 70006

  • Clinical Trials and Research Associates, Inc.

    Montebello, California, 90640

  • The Community Hospital

    Munster, Indiana, 46321

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37203

  • Florida Cancer Institute-New Hope

    New Port Richey, Florida, 34655

  • Ocala Oncology Center, PL

    Ocala, Florida, 34474

  • North Country Oncology-Hematology

    Oceanside, California, 92056

  • MD Anderson Cancer Center-Orlando

    Orlando, Florida, 32806

  • Berkshire Hematology Oncology, PC

    Pittsfield, Massachusetts, 01201

  • Texas Oncology - Plano East

    Plano, Texas, 75075-7787

  • Delta Hematology Oncology Associates, PC

    Portsmouth, Virginia, 23704

  • Pacific Hematology Oncology Associates

    San Francisco, California, 94115

  • Central Coast Medical Oncology

    Santa Maria, California, 93454

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

  • Rockwood Cancer Treatment Center

    Spokane, Washington, 99204

  • Medical Oncology Associates, PS

    Spokane, Washington, 99208

  • Hematology Oncology Associates, P.C.

    Stamford, Connecticut, 06902-3628

  • Northwest Cancer Center

    Sugar Land, Texas, 77479

  • Syracuse Veterns Affairs Medical Center

    Syracuse, New York, 13210

  • Texas Oncology - Tyler

    Tyler, Texas, 75702-8363

  • Texas Oncology - Waco

    Waco, Texas, 76712

Other trials in United States

Australia12 sites

  • Royal Adelaide Hospital, Cancer Centre

    Adelaide, South Australia, 5000

  • Flinders Medical Centre, Dept. of Oncology

    Bedford Park, South Australia, 5042

  • Box Hill Hospital

    Box Hill, Victoria, 3128

  • Royal Brisbane and Women's Hospital, Dept. of Medical Oncology

    Brisbane, Queensland, 4029

  • Lyell McEwin Hospital

    Elizabeth Vale, South Australia, 5112

  • Frankston Hospital, Oncology Day Unit

    Frankston, Victoria, 3199

  • Fremantle Hospital

    Fremantle, Western Australia, 6160

  • Epworth Healthcare

    Richmond, Victoria, 3002

  • The Tweed Hospital

    Tweed Heads, New South Wales, 2485

  • Southern Medical Day Oncology Care Centre

    Wollongong, New South Wales, 2500

  • The Queen Elizabeth Hospital

    Woodville South, South Australia, 5011

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

Germany8 sites

  • HELIOS Klinikum Emil von Behring

    Berlin, 14165

  • Krankenhaus Nordwest GmbH

    Frankfurt am Main, Hesse, 60488

  • Asklepios Fachkliniken München-Gauting

    Gauting, Bavaria, 82131

  • Städtisches Krankenhaus Martha-Maria Halle Dölau gGmbH

    Halle, Saxony-Anhalt, 06120

  • Asklepios Klinik Harburg

    Hamburg, 21075

  • Universitätsklinikum Heidelberg

    Heidelberg, Baden-Wurttemberg, 69126

  • Klinik Löwenstein gGmbH

    Löwenstein, Baden-Wurttemberg, 74245

  • Johannes-Wesling-Klinikum Minden

    Minden, North Rhine-Westphalia, 32429

Other trials in Germany

Spain5 sites

  • Hospital General Vall d'Hebron, Barcelona

    Barcelona, 08035

  • Hospital Clinic i Provincial de Barcelona

    Barcelona, 08036

  • Hospital Germans Trías i Pujol

    Barcelona, 08916

  • Fundación Jiménez Díaz

    Madrid, 28040

  • Hospital Regional Carlos Haya

    Málaga, Malaga, 29010

Other trials in Spain

Canada4 sites

  • Royal Victoria Hospital

    Barrie, Ontario, L4M 6M2

  • Grand River Regional Cancer Centre

    Kitchener, Ontario, N2G 1G3

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • Princess Margaret Hospital

    Toronto, Ontario, MSG 2L7

Other trials in Canada

Italy4 sites

  • Istituto Nazionale per la Ricerca sul Cancro

    Genova, 16132

  • Ospedale Unico Versilia

    Lido di Camaiore, Lucca, 55043

  • A.O. Seconda Università degli Studi di Napoli

    Naples, 80131

  • Azienda Ospedaliero-Univesitaria "San Luigi Gonzaga"

    Orbassano, Torino, 10043

Other trials in Italy

Poland3 sites

  • Specjalistyczny Szpital im. Alfreda Sokolowskiego

    Szczecin, West Pomeranian Voivodeship, 70-891

  • Wojewódzki Szpital Zespolony im. L. Rydygiera w Toruniu Szpital Dzieciecy

    Torun, Kuyavian-Pomeranian Voivodeship, 87-100

  • Centrum Onkologii - Instytut im. M. Sklodowskiej-Curie w Warszawie

    Warsaw, Masovian Voivodeship, 02-781

Other trials in Poland

Russia3 sites

  • Republican Clinical Oncologic Dispensary of Ministry of health of Republic Tatarstan

    Kazan', Tatarstan Republic, 420029

  • Cancer Research Center n.a. N.N. Blokhin

    Moscow, 115478

  • City Oncology Hospital # 62

    Moscow, 143423

Other trials in Russia

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Study of the Safety and Efficacy of Farletuzumab in Combination With a Platinum-Containing Doublet in Chemotherapy-Naive Subjects With Stage IV Adenocarcinoma of the Lung (FLAIR)

The primary objective of this study is to compare the effect of farletuzumab versus placebo in combination with either a platinum agent (carboplatin) with paclitaxel or a platinum agent (carboplatin or cisplatin) with pemetrexed followed by farletuzumab or placebo on investigator-assessed progression free survival (PFS) as determined by Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 or definitive clinical disease progression (eg, new occurrence of positive fluid cytology) in chemotherapy naive participants with folate receptoralpha (FRA)-expressing Stage IV adenocarcinoma of the lung.

Being tested
Farletuzumab, Placebo, Carboplatin, Paclitaxel, Pemetrexed
Medical subject headings
Adenocarcinoma of Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FarletuzumabBiological

    Also called MORAb-003

    Combination Therapy: Farletuzumab 7.5 mg/kg will be administered intravenously on Cycle 1, Week 1 and Cycle 1, Week 2 (loading dose). Beginning on Cycle 2, Week 1, farletuzumab (7.5 mg/kg) will be administered intravenously on Week 1 of all additional cycles.

    Monotherapy: Farletuzumab 7.5 mg/kg will be administered intravenously on Week 1 of every 3-week cycle until disease progression.

  • PlaceboOther

    Combination Therapy: Placebo will be administered intravenously on Cycle 1, Week 1 and Cycle 1, Week 2 (loading dose). Beginning on Cycle 2, Week 1, placebo will be administered IV on Week 1 of all additional cycles.

    Monotherapy: Placebo will be administered intravenously on Week 1 of every 3-week cycle until disease progression.

  • CarboplatinDrug

    Carboplatin will be administered intravenously to achieve area under the serum concentration-time curve of 5 to 6 mg/mL^min [AUC5-6].

  • PaclitaxelDrug

    Paclitaxel 200 mg/m^2 will be administered intravenously.

  • PemetrexedDrug

    Pemetrexed 500 mg/m^2 will be administered intravenously.

  • CisplatinDrug

    Cisplatin 75 mg/m^2 will be administered intravenously.

Study groups in NCT01218516
Study groupRoleWhat they receive
Farletuzumab plus ChemotherapyActive comparatorDuring Combination Therapy, farletuzumab will be given with a protocol-approved platinum doublet (either carboplatin/paclitaxel, carboplatin/pemetrexed, or cisplatin/pemetrexed) for at least 4, but not more than 6, cycles. Participants who experience clinical benefit from the Combination Therapy will enter the Monotherapy Phase and receive farletuzumab as monotherapy until disease progression.
Receives: Biological: Farletuzumab; Drug: Carboplatin; Drug: Paclitaxel; Drug: Pemetrexed; Drug: Cisplatin
Placebo plus ChemotherapyPlacebo comparatorDuring Combination Therapy, placebo will be given with a protocol-approved platinum doublet (either carboplatin/paclitaxel, carboplatin/pemetrexed, or cisplatin/pemetrexed) for at least 4, but not more than 6 cycles. Participants who experience clinical benefit from the Combination Therapy will enter the Monotherapy Phase and receive placebo as monotherapy until disease progression.
Receives: Other: Placebo; Drug: Carboplatin; Drug: Paclitaxel; Drug: Pemetrexed; Drug: Cisplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free Survival (PFS)

    PFS was defined as the time from the date of randomization to the date of the first observation of investigator-assessed (radiology review) progression based on Response Evaluation Criteria In Solid Tumors (RECIST) v.1.1 or other protocol-approved measures of disease progression (e.g., new occurrence of positive fluid cytology, newly diagnosed evidence of disease progression from histologic samples, PET-positive metastases, or new bone or brain metastases), or date of death, whatever the cause. Disease progression as assessed by the investigator per RECIST v1.0 was defined as at least a 20% increase in sum of longest diameters (RECIST definition) compared to baseline (or lowest sum while on study if less than baseline), or any new lesions (measurable or nonmeasurable).

    Measured: From date of first administration of study drug up to 6 month follow-up from randomization of the last participant, i.e., cut-off date 15 Dec 2012 for primary analysis and cut-off date of 1 Nov 2013 or up to approximately 28 months for final analysis

Secondary outcomes (4)

  1. Overall Response Rate (ORR)

    ORR, defined as the percentage of participants who had best overall response (BOR) of complete response (CR) or partial response (PR) as determined by investigator's radiologic assessments using RECIST 1.1 for target lesions and assessed by Magnetic resonance imaging (MRI) and computerized tomography (CT) scan (for double blind treatment period i.e. Randomization Phase). CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR = CR + PR.

    Measured: From Day 1 until documented radiographic progression, other protocol-approved measures of disease progression, withdrawal by participant, death due to any cause, or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis

  2. Duration of Response (DR)

    DR was derived for those participants with objective evidence of CR or PR. DR was defined as the time (in months) from first documentation of objective response (CR or PR) to the first documentation of disease progression (ie, objective tumor progression as assessed by investigator's radiology review or other protocol-approved measures of disease progression) or death due to any cause. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

    Measured: From the first documentation of objective response (CR or PR) to the first documentation of disease progression, death due to any cause, or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis

  3. Overall Survival (OS)

    OS was defined as the time (in months) from the date of randomization to the date of death, regardless of cause.

    Measured: From the date of randomization to the date of death due to any cause or up to cut-off date of 1 Nov 2013 (up to approximately 28 months) for final analysis

  4. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (SAEs)

    An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered with an investigational product. A serious adverse event (SAE) was defined as any untoward medical occurrence that at any dose; resulted in death, was life-threatening (i.e., the participant was at a risk of death at the time of the event; this did not include an event that hypothetically might have caused death if it had been more severe), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, or was a congenital abnormality/birth defect. In this study, TEAEs (defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.

    Measured: For each participant, from the first dose till 30 days after the last dose or cut-off date of 1 Nov 2013, i.e., up to approximately 28 months for final analysis

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Oct 2010 (estimated)
  2. Study start27 Jun 2011
  3. Primary completion15 Dec 2012
  4. Study completion1 Nov 2013

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
130 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01218516
Sponsor's protocol ID
MORAb-003-009
Other IDs
2010-022229-13
Status last verified
Mar 2018
First submitted
7 Oct 2010
Last updated
20 Aug 2020
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Farletuzumab, Carboplatin and Paclitaxel in people with Adenocarcinoma of the Lung, run by Morphotek at 93 sites in 8 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 20 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 93 sites in United States, Australia, Germany, Spain, Canada and 3 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. Some participants in this study may receive a placebo. 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 20 Aug 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: From date of first administration of study drug up to 6 month follow-up from randomization of the last participant, i.e., cut-off date 15 Dec 2012 for primary analysis and cut-off date of 1 Nov 2013 or up to approximately 28 months for final analysis). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01218516.

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 20 Aug 2020.

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