Phase 2b Study of Cetuximab With Platinum-Based Chemo as First Line Treatment of Recurrent or Advanced NSCLC

October 11, 2013 updated by: Accelerated Community Oncology Research Network

A Multi-Center Randomized Phase 2b Study of Cetuximab (Erbitux) in Combination With Platinum-Based Chemotherapy as First Line Treatment of Patients With Recurrent or Advanced Non-Small Cell Lung Cancer (NSCLC)

This study is testing the investigational drug, cetuximab, in combination with different chemotherapy drugs for lung cancer. The aim of the study is to determine which of the drug combinations looks most promising and should be tested further. The study will also look at what side effects may occur.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
601

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Anniston, Alabama, United States
    • Arkansas
      • Jonesboro, Arkansas, United States
    • California
      • Anaheim, California, United States
      • Azusa, California, United States
      • Burbank, California, United States
      • Campbell, California, United States
      • Greenbrae, California, United States
      • Hawthorne, California, United States
      • Mission Hills, California, United States
      • Orange, California, United States
      • Oxnard, California, United States
      • St. Helena, California, United States
    • Colorado
      • Fort Collins, Colorado, United States
    • Connecticut
      • Norwich, Connecticut, United States
      • Torrington, Connecticut, United States
      • Trumbull, Connecticut, United States
    • Florida
      • Fort Lauderdale, Florida, United States
      • Lake Worth, Florida, United States
      • Orange City, Florida, United States
      • Pembroke Pines, Florida, United States
      • St. Petersburg, Florida, United States
      • Titusville, Florida, United States
      • Weston, Florida, United States
    • Georgia
      • Augusta, Georgia, United States
      • Columbus, Georgia, United States
      • Lawrenceville, Georgia, United States
      • Marietta, Georgia, United States
      • Valdosta, Georgia, United States
    • Illinois
      • Elmhurst, Illinois, United States
      • Harvey, Illinois, United States
      • Joliet, Illinois, United States
      • Quincy, Illinois, United States
      • Skokie, Illinois, United States
    • Indiana
      • South Bend, Indiana, United States
      • Vincennes, Indiana, United States
        • Family Medicine of Vincennes
    • Iowa
      • Arnes, Iowa, United States
      • Bettendorf, Iowa, United States
      • Mason City, Iowa, United States
      • Waterloo, Iowa, United States
    • Kentucky
      • Hazard, Kentucky, United States
      • Louisville, Kentucky, United States
    • Louisiana
      • Lafayette, Louisiana, United States
      • Shreveport, Louisiana, United States
    • Maryland
      • Baltimore, Maryland, United States
      • Towson, Maryland, United States
    • Massachusetts
      • Springfield, Massachusetts, United States
      • Worchester, Massachusetts, United States
    • Missouri
      • Jefferson City, Missouri, United States
      • St. Joseph, Missouri, United States
      • St. Louis, Missouri, United States
    • Montana
      • Billings, Montana, United States
    • Nebraska
      • Grand Island, Nebraska, United States
      • Omaha, Nebraska, United States
    • New Hampshire
      • Portsmouth, New Hampshire, United States
    • New Jersey
      • Bellville, New Jersey, United States
      • Cherry Hill, New Jersey, United States
      • Elizabeth, New Jersey, United States
      • Hackensack, New Jersey, United States
    • New York
      • Bronx, New York, United States
      • East Setauket, New York, United States
      • Fresh Meadows, New York, United States
    • North Carolina
      • Fayetteville, North Carolina, United States
      • Gastonia, North Carolina, United States
      • Goldsboro, North Carolina, United States
    • Ohio
      • Columbus, Ohio, United States
      • Dayton, Ohio, United States
      • Middletown, Ohio, United States
      • Sandusky, Ohio, United States
    • Oregon
      • Bend, Oregon, United States
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States
      • Reading, Pennsylvania, United States
    • South Carolina
      • Sumter, South Carolina, United States
    • South Dakota
      • Sioux Falls, South Dakota, United States
    • Tennessee
      • Bristol, Tennessee, United States
      • Chattanooga, Tennessee, United States
      • Memphis, Tennessee, United States
    • Texas
      • Beaumont, Texas, United States
      • Corpus Christi, Texas, United States
      • Lubbock, Texas, United States
    • Vermont
      • Bennington, Vermont, United States
    • Washington
      • Kirkland, Washington, United States
      • Tacoma, Washington, United States
    • West Virginia
      • Huntington, West Virginia, United States
    • Wisconsin
      • Wauwatosa, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Written informed consent before study-related activities
  • Histologically or cytologically confirmed Stage IIIb with cytologically documented malignant pleural or pericardial effusion, Stage IV, or recurrent non-smal cell lung cancer (NSCLC) after resection or radiation for earlier stage disease
  • Measurable or evaluable disease (per modified Response Evaluation Criteria in Solid Tumors [RECIST] guidelines)
  • Male or female ≥ 18 years of age
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  • White blood count ≥ 3 x 10(9)/L with neutrophils ≥ 1.5 x 10(9)/L, platelet count ≥ 100 x 10(9)/L, and hemoglobin ≥ 9.5 g/dL
  • Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN or ≤ 5 x ULN in patients with liver mets
  • Serum creatinine ≤ 1.25 x ULN
  • Recovery from prior surgery or radiation to Grade 1 or better toxicity
  • Women of childbearing potential (WOCBP) and fertile men with partners of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 wks after the study in such a manner that the risk of pregnancy is minimized
  • WOCBP must have a negative serum or urine pregnancy test within 72 hrs prior to the start of study medication or in accordance with local regulations, whichever is of shorter duration

Exclusion Criteria:

  • WOCBP who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period and for up to 4 weeks after the study
  • Women who are pregnant or breastfeeding
  • Women with a positive pregnancy test during screening or prior to study drug administration
  • Sexually active fertile men not using effective birth control if their partners are women of child-bearing potential
  • Prior chemo for advanced NSCLC; neoadjuvant or post-operative adjuvant chemo is allowed if completed at least 12 months before study entry
  • Previous exposure to epidermal growth factor receptor (EGFR)-targeted therapy. Prior treatment with monoclonal antibodies targeting receptors other than the EGFR, such as bevacizumab, is allowed if completed > 30 days prior to randomization
  • Treatment with any investigational agent(s) within 4 weeks prior to study entry
  • Concurrent anti-cancer therapy (chemotherapy, hormonal therapy, biologic or targeted therapy) other than protocol therapy
  • Carcinoid, atypical carcinoid or small cell lung cancer
  • Symptomatic or uncontrolled mets in the central nervous system
  • Prior invasive malignancy requiring ongoing therapy within the past year
  • Active infection (infection requiring intravenous [IV] antibiotics), including active tuberculosis, known and declared HIV
  • Myocardial infarction within 6 months prior to study entry, uncontrolled congestive heart failure; or any current Grade 3 or 4 cardiovascular disorder despite treatment
  • Known allergic/hypersensitivity reaction to any of the components of study treatments
  • Peripheral neuropathy ≥ Grade 2, as assessed by Common Terminology Criteria for Adverse Events, version 3.0
  • History of significant neurologic or psychiatric disorders including but not limited to dementia, seizures, and bipolar disorder
  • Medical or psychological condition that would not permit the patient to complete the study or sign informed consent
  • Known drug abuse

Patients of all races and ethnic groups are eligible for this trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Paclitaxel, Carboplatin, Cetuximab (Arm A)
Patients with squamous or non-squamous histologies will receive carboplatin and paclitaxel for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion.
Drug: Cetuximab
Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks.
Other Names:
  • Erbitux
Drug: Paclitaxel
Paclitaxel 200 mg/m2 Day 1 every 21 days
Other Names:
  • Taxol
Drug: Carboplatin
Carboplatin AUC 6 Day 1 every 21 days
Other Names:
  • Paraplatin
Active Comparator: Platinum, Gemcitabine, Cetuximab (Arm B)
Patients with squamous or non-squamous histologies will receive gemcitabine with either carboplatin or cisplatin for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. The choice of platinum-based chemotherapy is also at the investigator's discretion.
Drug: Cetuximab
Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks.
Other Names:
  • Erbitux
Drug: Carboplatin
Carboplatin AUC 6 Day 1 every 21 days
Other Names:
  • Paraplatin
Drug: Gemcitabine
Gemcitabine 1,000 mg/m2 Days 1 and 8 every 21 days
Other Names:
  • Gemzar
Drug: Cisplatin
Cisplatin 75 mg/m2 Day I every 21 days
Other Names:
  • Platinol
Active Comparator: Platinum, Pemetrexed, Cetuximab (Arm C)
Patients with squamous histology will receive pemetrexed and either carboplatin or cisplatin for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. The choice of platinum-based chemotherapy is also at the investigator's discretion. Patients with non-squamous histology are not eligible for this arm.
Drug: Cetuximab
Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks.
Other Names:
  • Erbitux
Drug: Carboplatin
Carboplatin AUC 6 Day 1 every 21 days
Other Names:
  • Paraplatin
Drug: Cisplatin
Cisplatin 75 mg/m2 Day I every 21 days
Other Names:
  • Platinol

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Overall Survival by Treatment Arm
Time Frame: Survival was measured from the date of randomization to date of death due to any cause, assessed up to 36 months. Subjects who were alive at the date of last contact were censored at the date of last contact.
Survival was measured from the date of randomization to date of death due to any cause, assessed up to 36 months. Subjects who were alive at the date of last contact were censored at the date of last contact.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
1-year Survival by Treatment Arm
Time Frame: Survival was measured from the date of randomization to date of death due to any cause, assessed up to 36 months. Subjects who were alive at the date of last contact were censored at the date of last contact.
Survival was measured from the date of randomization to date of death due to any cause, assessed up to 36 months. Subjects who were alive at the date of last contact were censored at the date of last contact.
Overall Survival by Histology
Time Frame: Survival was measured from the date of randomization to date of death due to any cause, assessed up to 36 months. Subjects who were alive at the date of last contact were censored at the date of last contact.
Survival was measured from the date of randomization to date of death due to any cause, assessed up to 36 months. Subjects who were alive at the date of last contact were censored at the date of last contact.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Accelerated Community Oncology Research Network

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Lee Schwartzberg, MD, FACP, Accelerated Community Oncology Research Network

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 23, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 26, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 6, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AC01L08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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