Study of Taxane/Carboplatin +/- Cetuximab as First-Line Treatment for Patients With Advanced/Metastatic Non-Small Cell Lung Cancer

NCT00112294 | Completed Phase 3 Results

• 1 other identifier: CA225-099
• Study Type: interventional
• Target: 755
• Locations: 1 country
• Sites: 124

Brief Summary

The primary purpose of this clinical research study is to learn if patients treated with the combination of Taxane/Carboplatin plus Cetuximab (C/T/C) have a longer progression-free survival than patients treated with Taxane/Carboplatin (T/C) alone. The safety of this treatment will also be studied.

Conditions

Non-Small-Cell Lung Carcinoma

Keywords

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Median Number of Months of Progression-free Survival (PFS)

  Interval between randomization date \& earliest date of disease progression/death due to any cause, assessed by the Independent Radiology Review Committee (IRRC) using modified World Health Organization (WHO) criteria to define progressive disease (PD): \>=25% increase in sum of products of diameters (SOPD) of lesions compared with smallest SOPD recorded for study period or progression of any non-index lesion/appearance of new lesion. If no progression/death, date of last tumor assessment used. For participants who had no on-study tumor assessments \& were still alive, date of randomization used.

  From randomization to evidence of disease progression/death or date of last tumor assessment (up to 26 months).

Secondary Outcomes (15)

• Number of Participants With Complete Response (CR) or Partial Response (PR)

  From randomization to end of study drug therapy (up to 174 weeks).

• Number of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD)

  From randomization to end of study drug therapy (up to 174 weeks).

• Median Number of Months of Response

  Time from first occurrence of CR or PR (whichever was recorded first) to the date of PD, death or date of last tumor assessment (up to 19 months).

• Median Number of Months to Response

  Time from first dose of study therapy to the date of PR or CR, whichever occurred first (up to 13 months).

• Median Number of Months of Survival

  From randomization to death or date of last contact (up to 41 months).

Other Outcomes (1)

• Median Change From Baseline in Symptoms, by Time Point

  From randomization to evidence of disease progression/death or date of last symptom assessment (up to 33 weeks).

Study Arms (2)

Cetuximab+Taxane+Carboplatin (C/T/C)

ACTIVE COMPARATOR

Cetuximab was administered at an initial dose (Week 1) of 400 mg/m\^2 intravenous (IV) infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m\^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.

Drug: Paclitaxel (Taxane); Drug: Docetaxel (Taxane); Drug: Carboplatin; Drug: Cetuximab

Taxane+Carboplatin (T/C)

ACTIVE COMPARATOR

A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.

Drug: Paclitaxel (Taxane); Drug: Docetaxel (Taxane); Drug: Carboplatin

Interventions

Paclitaxel (Taxane) DRUG

IV, 225 mg/m\^2

Cetuximab+Taxane+Carboplatin (C/T/C); Taxane+Carboplatin (T/C)

Docetaxel (Taxane) DRUG

IV, 75 mg/m\^2

Cetuximab+Taxane+Carboplatin (C/T/C); Taxane+Carboplatin (T/C)

Carboplatin DRUG

AUC=6, q 3 weeks (6 cycles maximum)

Cetuximab+Taxane+Carboplatin (C/T/C); Taxane+Carboplatin (T/C)

Cetuximab DRUG

Intravenous, 400 mg/m\^2, initial dose followed by 250 mg/m\^2, weekly starting on Week 2

Also known as: Erbitux

Cetuximab+Taxane+Carboplatin (C/T/C)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must have advanced or metastatic non-small cell lung cancer that has not been previously treated with any chemotherapy.
• Tumor/disease lesions that can be measured bidimensionally.
• Must be able to carry-out work of light or sedentary nature (e.g. light house work, office work).
• Adequate recovery from recent surgery or radiation therapy.
• Must be at least 4 weeks from last major surgery or prior treatment with an investigational agent. At least 12 weeks from any radiation therapy to chest.
• Accessible for treatment, follow-up and required visits at a participating center(s).

You may not qualify if:

• Prior chemotherapy or adjuvant chemotherapy for the treatment of lung cancer.
• Prior treatment with cetuximab or other epidermal growth factor (EGFR)-targeted therapy.
• Prior severe infusion reaction to antibody therapy.
• Concurrent malignancy (previous malignancy without evidence of disease for 5 years will be allowed to enter trial).
• Concurrent chemotherapy or therapy with another investigational agent not indicated in the protocol.
• Serious uncontrolled medical disorders that would impair the ability to receive therapy.
• History of myocardial infarction within prior 3 months, uncontrolled angina, uncontrolled arrhythmia, or uncontrolled congestive heart failure.
• Symptomatic or uncontrolled metastases in the central nervous system. Subjects receiving a glucocorticoid for central nervous system (CNS) metastases are not eligible, but those receiving an anticonvulsant are eligible.
• Peripheral neuropathy \>= grade 2 (Common Toxicity Criteria Adverse Event \[CTCAE\] Version 3.0).
• Inadequate hematologic and/or liver and/or kidney function.
• Sexually active and fertile individuals or partners of these individuals who are unwilling or unable to use an acceptable method of birth control for entire trial and up to 4 weeks after the study.
• Women who are pregnant or breastfeeding.
• Women with a positive pregnancy test on enrollment prior to study drug administration.
• Altered mental status or psychiatric condition that prohibits understanding or rendering of consent.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (124)

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Birmingham, Alabama, United States

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Mobile, Alabama, United States

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Anchorage, Alaska, United States

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Tucson, Arizona, United States

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Springdale, Arkansas, United States

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Anaheim, California, United States

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Bakersfield, California, United States

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Concord, California, United States

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Fountain Valley, California, United States

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Gilroy, California, United States

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Long Beach, California, United States

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Los Angeles, California, United States

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Montebello, California, United States

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Oxnard, California, United States

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Rancho Mirage, California, United States

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San Diego, California, United States

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Stockton, California, United States

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Vista, California, United States

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Lakewood, Colorado, United States

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Binghamton, Connecticut, United States

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Hartford, Connecticut, United States

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New London, Connecticut, United States

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Norwich, Connecticut, United States

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Stamford, Connecticut, United States

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Waterbury, Connecticut, United States

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Washington D.C., District of Columbia, United States

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Boca Raton, Florida, United States

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Boynton Beach, Florida, United States

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Fort Lauderdale, Florida, United States

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Fort Myers, Florida, United States

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Inverness, Florida, United States

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Jacksonville, Florida, United States

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Lakeland, Florida, United States

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Lecanto, Florida, United States

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Pembroke Pines, Florida, United States

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Port Saint Lucie, Florida, United States

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Tamarac, Florida, United States

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Tampa, Florida, United States

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Augusta, Georgia, United States

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Columbus, Georgia, United States

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Marietta, Georgia, United States

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Honolulu, Hawaii, United States

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Evanston, Illinois, United States

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Joliet, Illinois, United States

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Naperville, Illinois, United States

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Normal, Illinois, United States

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Skokie, Illinois, United States

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Fort Wayne, Indiana, United States

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Muncie, Indiana, United States

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New Albany, Indiana, United States

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Terre Haute, Indiana, United States

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Vincennes, Indiana, United States

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Wichita, Kansas, United States

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Hazard, Kentucky, United States

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Paducah, Kentucky, United States

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Annapolis, Maryland, United States

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Baltimore, Maryland, United States

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Westminster, Maryland, United States

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Boston, Massachusetts, United States

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Brockton, Massachusetts, United States

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Flint, Michigan, United States

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Free Soil, Michigan, United States

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Grand Rapids, Michigan, United States

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Jackson, Michigan, United States

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Dulluth, Minnesota, United States

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Minneapolis, Minnesota, United States

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Saint Louis Park, Minnesota, United States

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Jackson, Mississippi, United States

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Columbia, Missouri, United States

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Jefferson City, Missouri, United States

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Dover, New Hampshire, United States

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Newark, New Jersey, United States

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Cooperstown, New York, United States

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New City, New York, United States

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New Rochelle, New York, United States

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Northport, New York, United States

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Rochester, New York, United States

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The Bronx, New York, United States

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Valhalla, New York, United States

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Burlington, North Carolina, United States

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Charlotte, North Carolina, United States

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Gastonia, North Carolina, United States

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Greensboro, North Carolina, United States

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Greenville, North Carolina, United States

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Hickory, North Carolina, United States

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Morganton, North Carolina, United States

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Wilmington, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Bismarck, North Dakota, United States

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Canton, Ohio, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Columbus, Ohio, United States

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Dayton, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Bethlehem, Pennsylvania, United States

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Dunmore, Pennsylvania, United States

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Harrisburg, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pottstown, Pennsylvania, United States

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Sayre, Pennsylvania, United States

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West Reading, Pennsylvania, United States

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Providence, Rhode Island, United States

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Charleston, South Carolina, United States

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Columbia, South Carolina, United States

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Mt. Pleasant, South Carolina, United States

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Spartanburg, South Carolina, United States

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Sumter, South Carolina, United States

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Chattanooga, Tennessee, United States

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Collierville, Tennessee, United States

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Cookeville, Tennessee, United States

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Amarillo, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Lubbock, Texas, United States

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Danville, Virginia, United States

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Lynchburg, Virginia, United States

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Richmond, Virginia, United States

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Everett, Washington, United States

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Lacey, Washington, United States

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Tacoma, Washington, United States

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Huntington, West Virginia, United States

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La Crosse, Wisconsin, United States

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Madison, Wisconsin, United States

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MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Paclitaxel; taxane; Docetaxel; Carboplatin; Cetuximab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

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: OTHER
• 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: June 1, 2005
• First Posted: June 2, 2005
• Study Start: December 1, 2004
• Primary Completion: April 1, 2007
• Study Completion: August 1, 2008
• Last Updated: December 24, 2015
• Results First Posted: October 5, 2010

Record last verified: 2015-11

Locations

US (124)