NCT00095199

Brief Summary

This trial is a multicenter, open-label, randomized, Phase III study in patients with recurrent or progressive Non-Small Cell Lung Cancer (NSCLC) after failure of an initial platinum-based chemotherapy. Patients will receive either Docetaxel or Pemetrexed as chemotherapy at the investigator's choice. Within each chemotherapy group, patients will be randomized to receive Cetuximab plus chemotherapy or chemotherapy alone (Cetuximab \& Pemetrexed or Pemetrexed alone; Cetuximab \& Docetaxel or Docetaxel alone).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
939

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jan 2005

Longer than P75 for phase_3

Geographic Reach
2 countries

67 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 2, 2004

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2005

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

October 15, 2012

Completed
Last Updated

October 15, 2012

Status Verified

September 1, 2012

Enrollment Period

6.5 years

First QC Date

November 1, 2004

Results QC Date

June 19, 2012

Last Update Submit

September 13, 2012

Conditions

Non Small Cell Lung Cancer

Keywords

Recurrent or Progressive Non-Small Cell Lung CancerSecond-line therapyDocetaxelPemetrexedCetuximabFailed platinum-based therapyNSCLC

Outcome Measures

Primary Outcomes (1)

  • Progression Free Survival (PFS)

    PFS was defined as the time from randomization until the date of progressive disease (PD) or death from any cause. Participants who were alive and without progression were censored at the date of their last tumor assessment. PFS was assessed by the independent review committee (IRC) in the Pemetrexed group (Cetuximab \& Pemetrexed versus Pemetrexed) and by the investigator in the Docetaxel group (Cetuximab \& Docetaxel versus Docetaxel).

    Randomization to progression of disease or death due to any cause up to 59.6 months

Secondary Outcomes (7)

  • Overall Survival (OS)

    Randomization to the date of death from any cause up to 72.8 months

  • Proportion of Randomized Participants With the Best Overall Response (OR) of Partial Response (PR) or Complete Response (CR) (Overall Response Rate [ORR])

    Randomization until progression of disease or death from any cause up to 59.6 months

  • Proportion of Randomized Participants With Best Overall Response (OR) of Partial Response (PR), Complete Response (CR), or Stable Disease (SD)

    Randomization to progression of disease or death due to any cause up to 59.6 months

  • Percentage of Participants With Symptomatic Response (Symptom Response Rates) Using the Lung Cancer Subscale (LCS) Scores of Functional Assessment of Cancer Therapy for Participants With Lung Cancer (FACT-L)

    At baseline, every 3 weeks and 30 days after end of therapy up to 50 months

  • Time to Symptomatic Progression

    Randomization until symptomatic progression up to 48.3 months

  • +2 more secondary outcomes

Study Arms (4)

Cetuximab & Pemetrexed

EXPERIMENTAL
Drug: PemetrexedBiological: Cetuximab

Pemetrexed

ACTIVE COMPARATOR
Drug: Pemetrexed

Cetuximab & Docetaxel

EXPERIMENTAL
Biological: CetuximabDrug: Docetaxel

Docetaxel

ACTIVE COMPARATOR
Drug: Docetaxel

Interventions

PemetrexedDRUG

Pemetrexed 500 mg/m\^2 administered intravenously on Day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week) cycles.

Also known as: Alimta, LY231514
Cetuximab & PemetrexedPemetrexed
CetuximabBIOLOGICAL

Cetuximab 400/250 mg/m\^2 (initial/weekly) administered intravenously on Days 1, 8, and 15 (3-week) cycles until disease progression or unacceptable toxicity.

Also known as: Erbitux, LY2939777
Cetuximab & DocetaxelCetuximab & Pemetrexed
DocetaxelDRUG

Docetaxel 75 mg/m\^2 administered intravenously on Day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week) cycles.

Cetuximab & DocetaxelDocetaxel

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pathologic confirmation of metastatic, unresectable, or locally-advanced NSCLC.
  • Disease progression during or following one prior platinum-based chemotherapy regimen for advanced disease (stage IIIB or IV).
  • Bidimensionally measurable disease.
  • Karnofsky performance status score of 60 to 100 at study entry.
  • The participant has tumor tissue available for immunohistochemical determination of epidermal growth factor (EGFR) expression.
  • Adequate recovery from recent surgery, chemotherapy, and radiation therapy. At least 4 weeks must have elapsed from major surgery, prior chemotherapy, prior treatment with an investigational agent, or prior radiation therapy (palliative radiation therapy is allowed).
  • Accessible for treatment and follow-up. Participants enrolled in this trial must be treated at the participating center.
  • Women of childbearing potential (WOCBP) and fertile men with partners of childbearing potential must be using an adequate method of contraception.
  • WOCBP must have a negative serum or urine pregnancy test.

You may not qualify if:

  • Women who are pregnant or breastfeeding.
  • Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
  • A serious uncontrolled medical disorder that would impair the ability of the patient to receive protocol therapy.
  • Symptomatic or uncontrolled metastases in the brain. Participants receiving a glucocorticoid for brain metastases will be excluded, but those receiving anticonvulsants will be eligible.
  • Uncontrolled pleural effusion or ascites.
  • Peripheral neuropathy greater than grade 2, as assessed by the National Cancer Institutes-Common Toxicity Criteria Adverse Events (NCI-CTCAE), Version 3.0.
  • Any concurrent malignancy other than basal cell skin cancer, or carcinoma in situ of the cervix. Patients with a previous malignancy, but without evidence of disease for greater than or equal 3 years will be allowed to enter the trial.
  • More than one prior chemotherapy regimen for advanced disease.
  • Inadequate hematologic function defined by an absolute neutrophil count (ANC) \<1,500/mm3, a platelet count \<100,000/mm3, and a hemoglobin level \<9 g/dL. Red blood cell transfusions are not permitted within 7 days of receiving cetuximab, docetaxel, or pemetrexed.
  • Inadequate hepatic function, defined by a total bilirubin level \>1.5 times the upper limit of normal (ULN), aspartate transaminase (AST) and alanine aminotransferase (ALT) levels \>2.5 times the ULN (greater than or equal to 5 times the ULN if known liver metastases), and an alkaline phosphatase level \>5.0 times the ULN.
  • Inadequate renal function defined by a serum creatinine level \>1.5 times the ULN.
  • Prior treatment with cetuximab, or any other epidermal growth factor receptor inhibitors, including tyrosine kinase inhibitors, such as gefitinib or erlotinib. Participants must not have received prior chimerized or murine monoclonal antibody therapy. Prior treatment with other monoclonal antibodies targeting receptors other than the EGFR is permitted \>30 days prior to randomization.
  • Prior treatment with docetaxel or pemetrexed therapy.
  • Inability or unwillingness to take folic acid or vitamin B12 supplementation.
  • Inability or unwillingness to interrupt nonsteroidal anti-inflammatory drugs (NSAIDs) for a 5-day period (8-day period for long-acting agents such as piroxicam). Aspirin will be permitted during the study.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (67)

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Birmingham, Alabama, 35294, United States

Location

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Montgomery, Alabama, 36106, United States

Location

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Phoenix, Arizona, 85012, United States

Location

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Tucson, Arizona, 85715, United States

Location

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Tuscon, Arizona, 85704, United States

Location

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Greenbrae, California, 94904, United States

Location

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La Jolla, California, 92093, United States

Location

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Denver, Colorado, 80218, United States

Location

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Stamford, Connecticut, 06902, United States

Location

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Trumbull, Connecticut, 06611, United States

Location

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Jacksonville, Florida, 32256, United States

Location

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Lake Worth, Florida, 33461, United States

Location

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West Palm Beach, Florida, 33401, United States

Location

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Athens, Georgia, 30607, United States

Location

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Atlanta, Georgia, 30341, United States

Location

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Augusta, Georgia, 30901, United States

Location

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Chicago, Illinois, 60674, United States

Location

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Indianapolis, Indiana, 46227, United States

Location

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Overland Park, Kansas, 66210, United States

Location

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Wichita, Kansas, 67214, United States

Location

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Metairie, Louisiana, 70006, United States

Location

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Bethesda, Maryland, 20817, United States

Location

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Frederick, Maryland, 21701, United States

Location

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Kalamazoo, Michigan, 49048, United States

Location

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Mount Clemens, Michigan, 48043, United States

Location

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Minneapolis, Minnesota, 55404, United States

Location

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Saint Louis Park, Minnesota, 55416, United States

Location

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Saint Joseph, Missouri, 64507, United States

Location

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Billings, Montana, 59101, United States

Location

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Las Vegas, Nevada, 89169, United States

Location

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Cherry Hill, New Jersey, 08003, United States

Location

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Albany, New York, 12208, United States

Location

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Rochester, New York, 14623, United States

Location

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Cary, North Carolina, 27518, United States

Location

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Concord, North Carolina, 28025, United States

Location

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High Point, North Carolina, 27262, United States

Location

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Cincinnati, Ohio, 45267, United States

Location

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Columbus, Ohio, 43215, United States

Location

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Tulsa, Oklahoma, 74136, United States

Location

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Eugene, Oregon, 97401, United States

Location

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Portland, Oregon, 97239, United States

Location

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Dunmore, Pennsylvania, 18512, United States

Location

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Kingston, Pennsylvania, 18704, United States

Location

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Philadelphia, Pennsylvania, 19114, United States

Location

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Greenville, South Carolina, 29605, United States

Location

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Hilton Head Island, South Carolina, 29926, United States

Location

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Mt. Pleasant, South Carolina, 29464, United States

Location

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Memphis, Tennessee, 38138, United States

Location

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Bedford, Texas, 76022, United States

Location

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Dallas, Texas, 75246, United States

Location

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Grapevine, Texas, 76051, United States

Location

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Houston, Texas, 77030, United States

Location

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Mesquite, Texas, 75150, United States

Location

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Sugar Land, Texas, 77479, United States

Location

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Tyler, Texas, 75702, United States

Location

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Salt Lake City, Utah, 84106, United States

Location

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Colchester, Vermont, 05446, United States

Location

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Norfolk, Virginia, 23502, United States

Location

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Richmond, Virginia, 23249, United States

Location

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Seattle, Washington, 98133, United States

Location

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Vancouver, Washington, 98684, United States

Location

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Calgary, Alberta, T2N 4N2, Canada

Location

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Vancouver, British Columbia, V5Z 4E6, Canada

Location

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Ottawa, Ontario, K1H 8L6, Canada

Location

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Montreal, Quebec, H2L 4M1, Canada

Location

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Saint-Jérôme, Quebec, J7Z 5T3, Canada

Location

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Sainte-Foy, Quebec, G1V 4G2, Canada

Location

Related Publications (1)

  • Kim ES, Neubauer M, Cohn A, Schwartzberg L, Garbo L, Caton J, Robert F, Reynolds C, Katz T, Chittoor S, Simms L, Saxman S. Docetaxel or pemetrexed with or without cetuximab in recurrent or progressive non-small-cell lung cancer after platinum-based therapy: a phase 3, open-label, randomised trial. Lancet Oncol. 2013 Dec;14(13):1326-36. doi: 10.1016/S1470-2045(13)70473-X. Epub 2013 Nov 12.

    PMID: 24231627DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungRecurrence

Interventions

PemetrexedCetuximabDocetaxel

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

GuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsGlutamatesAmino Acids, AcidicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DicarboxylicAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsSerum GlobulinsGlobulinsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
800-545-5979

Study Officials

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

    Eli Lilly and Company

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2004

First Posted

November 2, 2004

Study Start

January 1, 2005

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

October 15, 2012

Results First Posted

October 15, 2012

Record last verified: 2012-09

Locations

US(61)CA(6)