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Lung CancerPhase 2NCT00111839

Effects of Matuzumab in Combination With Pemetrexed for the Treatment of Advanced Lung Cancer

A Phase 2 study testing Pemetrexed and Matuzumab in people with Lung Cancer and Non Small Cell Lung Carcinoma, run by EMD Serono at 58 sites in 3 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

This open-label, multicenter, randomized, controlled, Phase II study is planned to answer questions about how the drug, matuzumab (EMD 72000), works and is part of an effort aimed to develop better treatment for advanced lung cancer by combining matuzumab, a monoclonal antibody, with a chemotherapy treatment, called… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer, Non Small Cell Lung Carcinoma
What is being tested?
Pemetrexed and Matuzumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
58 sitesin 3 countries
Study dates
31 May 2005to 31 Mar 2009
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

  • Written informed consent provided prior to any screening procedure
  • Male or female, greater than (>) 18 years of age
  • Histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC)
  • Demonstrated PD on or after first-line chemotherapy for Stage IIIB/IV disease. The first-line therapy must consist of platinum-based regimens in combination with taxanes, gemcitabine or vinorelbine. Stage IIIB/IV participants must have measurable disease (tumor) without clinically significant pleural effusion unless the pleural effusion can be effectively drained prior to admission into the study
  • A chemotherapy-free interval of at least 3 weeks between the end of first-line chemotherapy and start of study treatment
  • At least 1 measurable lesion according to the modified World Health Organization (WHO) criteria
Show all 11Show fewer
  • Archived tissue or cytologic sample available for the determination of epidermal growth factor receptor (EGFR) expression
  • Eastern cooperative oncology group (ECOG) performance status 0-1
  • Life expectancy >12 weeks
  • Adequate baseline organ functions, defined as: Serum creatinine less than or equal to (≤)1.5*upper limit of normal (ULN). In case of borderline values for serum creatinine, creatinine clearance must be greater than or equal to (≥) 45 millimeters per minute (mL/min); Total bilirubin <1.5*ULN; Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤2.5*ULN (participants with liver metastases should have ALT/AST <5*ULN.); Absolute neutrophil count ≥1500per cubic millimeter(mm^3); Platelet count ≥100000/mm^3; Hemoglobin level ≥10 grams per deciliter
  • If procreative potential (male or female), willingness to use effective contraceptive methods for the duration of treatment and continuing for 2 months after the last dose. Participants of procreative potential are defined as any fertile male, or any female who has experienced menarche and who is not postmenopausal (defined as age-related amenorrhea ≥12 months) or who has not undergone successful surgical sterilization (hysterectomy or bilateral oophorectomy)

Who cannot join

  • Radiotherapy or major surgery within 30 days prior to the start of study treatment
  • Prior treatment with an EGFR-directed therapy or with EGFR signal transduction inhibitors
  • Prior treatment with pemetrexed
  • Pregnant (confirmed by beta-human chorionic gonadotropin [β-HCG]) or lactating female
  • Weight loss >10% within 12 weeks prior to the start of study treatment
  • Documented or symptomatic brain metastases or leptomeningeal disease
Show all 17Show fewer
  • Myocardial infarction within 6 months prior to the start of study treatment, uncontrolled congestive heart failure, or any current New York Heart Association Grade III or IV cardiovascular disorder despite treatment
  • Presence of a Grade ≥2 preexisting skin disorder (except for alopecia)
  • Previous diagnosis of autoimmune disease with significant organ involvement
  • Concurrent malignancies or invasive carcinomas diagnosed within the past 5 years, except for adequately treated basal cell carcinoma of the skin or in situ carcinoma of the cervix
  • Any significant disease that, in the Investigator's opinion, should exclude the participant from the study
  • History of significant neurologic or psychiatric disorder (for example, dementia, seizures, or bipolar disorder)
  • History of drug abuse within 6 months prior to the start of study treatment
  • Known conditions that require concurrent treatment with a nonpermitted drug
  • Presence of a contraindication to the study treatment(s) according to the current Investigator's Brochure (IB) for matuzumab and the labeling for pemetrexed
  • Known hypersensitivity to the study treatment or any of its components
  • Participation in another clinical study within 30 days prior to the start of study treatment

Trial locations and contacts

58 sites in 3 countries.

58 sites in 3 countries

United States42 sites

  • New York Oncology

    Albany, New York, 12208

  • Peachtree Hematology and Oncology

    Atlanta, Georgia, 30309

  • Hematology-Oncology Clinic

    Baton Rouge, Louisiana, 70808

  • Deaconess Billings Clinic

    Billings, Montana, 59101

  • Tuffs-New England Medical Center

    Boston, Massachusetts, 20111

  • University of North Carolina

    Chapel Hill, North Carolina, 27599

  • Presbyterian Hospital Cancer Center

    Charlotte, North Carolina, 28204

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University of Illinois

    Chicago, Illinois, 60612

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • University of Missouri

    Columbia, Missouri, 65203

  • Mary Crowley Research Center

    Dallas, Texas, 75246

  • Cancer Care Specialists of Central Illinois

    Decatur, Illinois, 62256

  • Henry Ford Health Systems

    Detroit, Michigan, 48202

  • Hematology & Oncology Associates of NEPA

    Dunmore, Pennsylvania, 19107

  • Cancer Institute of Alexian Brothers

    Elk Grove Village, Illinois, 60007

  • Holy Cross Hospital

    Fort Lauderdale, Florida, 33308

  • Frederick Memorial Hospital

    Frederick, Maryland, 21701

  • West Michigan Regional Cancer and Blood Center

    Free Soil, Michigan, 49411

  • Indiana Oncology Hematology Consultants

    Indianapolis, Indiana, 46202

  • Hematology-Oncology of Indiana PC

    Indianapolis, Indiana, 46260

  • Integrated Community Oncology Network

    Jacksonville, Florida, 32256

  • Dayton Oncology and Hematology

    Kettering, Ohio, 45409

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Nebraska Hematology-Oncology, PC

    Lincoln, Nebraska, 68506

  • University of Arkansas, Arkansas Cancer Research Center

    Little Rock, Arkansas, 72205

  • University of Southern California/Norris Cancer Center

    Los Angeles, California, 90033

  • Louisville Oncology

    Louisville, Kentucky, 40202

  • James Graham Brown Cancer Center

    Louisville, Kentucky, 40402

  • University of Wisconsin

    Madison, Wisconsin, 53792

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Cancer Center or Florida

    Ocoee, Florida, 34761

  • Kansas City Cancer Center

    Overland Park, Kansas, 66210

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • Rainer Oncology Professional Services

    Puyallup, Washington, 98372

  • Sharp Memorial Hospital

    San Diego, California, 92123

  • Northern Indiana Cancer Research Consortium

    South Bend, Indiana, 46601

  • Cancer Care Northwest

    Spokane, Washington, 99218

  • Georgia Cancer Specialists

    Tucker, Georgia, 30084

  • Arizona Clinical Research Center

    Tucson, Arizona, 85715

  • Tyler Cancer Center

    Tyler, Texas, 75702

Other trials in United States

Germany12 sites

  • Research Site

    Cologne

  • Research Site

    Essen

  • Research Site

    Freiburg im Breisgau

  • Research Site

    Gauting

  • Research Site

    Göttingen

  • Research Site

    Großhansdorf

  • Research Site

    Halle

  • Research Site

    Hamburg

  • Research Site

    Heidelberg

  • Research Site

    Mainz

  • Research Site

    München

  • Research Site

    Recklinghausen

Other trials in Germany

Austria4 sites

  • Research Site

    Linz

  • Research Site

    Salzburg

  • Research Site

    Vienna

  • Research Site

    Wels

Other trials in Austria

About this study

Official title: Randomized, Phase II, Open-Label Controlled Study of Two Different Doses and Schedules of EMD 72000 (Matuzumab) in Combination With Pemetrexed, or Pemetrexed Alone, as Second-Line Treatment for Stage IIIB/IV Non-Small Cell Lung Cancer and Progressive Disease on or After First-Line Treatment With a Platinum in Combination With Taxanes, Gemcitabine and Vinorelbine

This open-label, multicenter, randomized, controlled, Phase II study is planned to answer questions about how the drug, matuzumab (EMD 72000), works and is part of an effort aimed to develop better treatment for advanced lung cancer by combining matuzumab, a monoclonal antibody, with a chemotherapy treatment, called pemetrexed.

Being tested
Pemetrexed, Matuzumab
Keywords
Lung cancer
Medical subject headings
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • PemetrexedDrug

    Pemetrexed will be administered IV until PD or the occurrence of unacceptable toxicity.

  • MatuzumabDrug

    Matuzumab will be administered IV until PD or the occurrence of unacceptable toxicity.

Study groups in NCT00111839
Study groupRoleWhat they receive
Pemetrexed AloneActive comparatorParticipants will receive pemetrexed 50 milligrams per square meter (mg/m^2) intravenous (IV) infusion every 3 weeks until disease progression (PD) or the occurrence of unacceptable toxicity.
Receives: Drug: Pemetrexed
Pemetrexed Plus Matuzumab 800 mg per WeekExperimentalParticipants will receive pemetrexed 50 mg/m^2 IV infusion every 3 weeks in combination with matuzumab 800 milligrams (mg) IV infusion once every week. Treatment will continue until PD or the occurrence of unacceptable toxicity.
Receives: Drug: Pemetrexed; Drug: Matuzumab
Pemetrexed Plus Matuzumab 1600 mg Every 3 WeeksExperimentalParticipants will receive pemetrexed 50 mg/m^2 IV infusion every 3 weeks in combination with matuzumab 1600 mg IV infusion every 3 weeks. Treatment will continue until PD or the occurrence of unacceptable toxicity.
Receives: Drug: Pemetrexed; Drug: Matuzumab

What is being measured

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

  1. Number of Participants With Objective Response Assessed by Independent Review Committee

    Objective response was defined as having a complete response (CR) or a partial response (PR). Response assessment was performed using modified World Health Organization (WHO) criteria. Complete response: disappearance of all index and non-index lesions, without appearance of any new lesion. PR: greater than (>) 50 percent (%) decrease from baseline in sum of product of diameters of index lesions, without appearance of any new lesion.

    Measured: Baseline up to PD or death due to any cause (up to approximately 2 years)

Secondary outcomes (4)

  1. Overall Survival (OS)

    OS was defined as the duration from randomization to death (due to any cause). OS was estimated using Kaplan-Meier analysis.

    Measured: Baseline up to PD or death due to any cause (up to approximately 3.5 years)

  2. Progression-Free Survival (PFS)

    PFS was defined as the time from randomization to the first documentation of disease progression (PD) or to death due to any cause, whichever occurred first. PD: >25% increase in one or more lesions, or appearance new lesions. PFS was estimated using Kaplan-Meier analysis.

    Measured: Baseline up to PD or death due to any cause (up to approximately 3.5 years)

  3. Duration of Objective Response Assessed by Independent Review Committee

    Objective response was defined as having a CR or a PR. Response assessment was performed using modified WHO criteria. CR: disappearance of all index and non-index lesions, without appearance of any new lesion. PR: >50% decrease from baseline in sum of product of diameters of index lesions, without appearance of any new lesion. Duration of objective response was defined as time from first appearance of CR or PR to time of PD (>25% increase in one or more lesions, or appearance new lesions) or death. Duration of objective response was to be assessed using Kaplan-Meier analysis.

    Measured: From first documented objective response to PD or death due to any cause (up to approximately 3.5 years)

  4. Change From Baseline to Cycle 2 in Global Quality of Life (QoL), as Assessed Using Lung Cancer Symptom Scale (LCSS)

    The LCSS consisted of 9 items: 6 items focused on lung cancer symptoms (loss of appetite, fatigue, cough, dyspnea, hemoptysis, and pain] and 3 items were global items (symptom distress, interference with activity level, and global QoL). The global QoL item scores are reported here. The total global QoL item score ranged from 0 (worse QoL) to 100 (best QoL).

    Measured: Baseline, Cycle 2 (Cycle length = 3 weeks)

Timeline

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

  1. First posted27 May 2005 (estimated)
  2. Study start31 May 2005
  3. Primary completion31 Jul 2007
  4. Study completion31 Mar 2009

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
None (open label)
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00111839
Sponsor's protocol ID
EMD 72000-031
Other IDs
2006-000899-32
Status last verified
Apr 2018
First submitted
26 May 2005
Last updated
6 Apr 2018
Data monitoring committee
No

Publications

  • Schiller JH, von Pawel J, Schutt P, Ansari RH, Thomas M, Saleh M, McCroskey RD, Pfeifer W, Marsland TA, Kloecker GH, Sebastian M, Pirker R, Kurek R, Beadman C, Socinski MA. Pemetrexed with or without matuzumab as second-line treatment for patients with stage IIIB/IV non-small cell lung cancer. J Thorac Oncol. 2010 Dec;5(12):1977-85. doi: 10.1097/JTO.0b013e3181f4a5c9.

    PubMed 20978446

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pemetrexed and Matuzumab in people with Lung Cancer and Non Small Cell Lung Carcinoma, run by EMD Serono at 58 sites in 3 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 11 inclusion and 17 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 6 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 58 sites in United States, Germany, Austria. 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 6 Apr 2018). 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?

Number of Participants With Objective Response Assessed by Independent Review Committee (time frame: Baseline up to PD or death due to any cause (up to approximately 2 years)). 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 NCT00111839, which also lists 1 linked publication.

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 6 Apr 2018.

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