A Study of Induction and Maintenance Treatment of Advanced or Metastatic Non Squamous Non-Small Cell Lung Cancer

NCT ID: NCT00867009

Last Updated: 2015-06-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 113 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2014-09-30

Brief Summary

This study will estimate the response rate in patients with advanced or metastatic non-squamous Non-Small Cell Lung Cancer. Patients who don't progress after 4 to 6 cycles of induction treatment with pemetrexed, cisplatin and cetuximab will receive maintenance treatment with pemetrexed and cetuximab.

Conditions

Non-Small-Cell Lung Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Induction/maintenance Therapy

pemetrexed, cisplatin and cetuximab followed by pemetrexed and cetuximab

Group Type: EXPERIMENTAL

Pemetrexed

Intervention Type: DRUG

Induction therapy: 500 mg/m², intravenous, on Day 1 of each 21-day cycle for 4 to 6 cycles Maintenance therapy: 500 mg/m², intravenous, on Day 1 of each 21-day cycle until progressive disease or treatment discontinuation

Cisplatin

Intervention Type: DRUG

Induction therapy: 75 mg/m², intravenous, on Day 1 of each 21-day cycle for 4 to 6 cycles

Cetuximab

Intervention Type: DRUG

Induction therapy: Loading dose of 400 mg/m², intravenous, on Day 1 of cycle 1, then 250 mg/m², intravenous, weekly for 4 to 6 cycles, 21 day cycles

Maintenance therapy: 250 mg/m², intravenous, weekly until progressive disease or treatment discontinuation

Interventions

Pemetrexed

Induction therapy: 500 mg/m², intravenous, on Day 1 of each 21-day cycle for 4 to 6 cycles Maintenance therapy: 500 mg/m², intravenous, on Day 1 of each 21-day cycle until progressive disease or treatment discontinuation

Intervention Type: DRUG

Cisplatin

Induction therapy: 75 mg/m², intravenous, on Day 1 of each 21-day cycle for 4 to 6 cycles

Intervention Type: DRUG

Cetuximab

Induction therapy: Loading dose of 400 mg/m², intravenous, on Day 1 of cycle 1, then 250 mg/m², intravenous, weekly for 4 to 6 cycles, 21 day cycles

Maintenance therapy: 250 mg/m², intravenous, weekly until progressive disease or treatment discontinuation

Intervention Type: DRUG

Other Intervention Names

Alimta; LY231514

Eligibility Criteria

Inclusion Criteria

• Patient must sign an informed consent document for clinical and translational research.
• Patient must have locally advanced or metastatic nonsquamous Non-Small Cell Lung Cancer.
• Patient must have biological tissue available from your diagnosis tumor for detection of some biomarkers (translational research).
• Patient cannot be receiving nor have received any prior systemic anticancer therapy, immunotherapy, targeted therapy, or biological therapy for your lung cancer (except chemotherapy given after surgery if it has been completed more than one year before the study entry).
• Patient is allowed to have had prior radiation therapy as long as it was not more than 25% of the bone marrow and did not include the whole pelvis. Prior radiation therapy should be completed at least 2 weeks prior to first study drug. Thoracic radiation must be completed more than 12 weeks before the study entry. You must be recovered from the toxic effects.
• Patient must have at least 1 measurable tumor lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines.
• Patient must at least be able to be physically mobile, take care of yourself, and must be up and about and able to perform light activities such as light housework or office work.
• Test results assessing the function of blood forming tissue, kidneys, and liver must be satisfactory.
• Females must be sterile, postmenopausal or on contraception.
• Males must be on contraception or sterile (for example post-vasectomy).

Exclusion Criteria

• Patient cannot have symptomatic central nervous system metastases.
• Patient cannot have an active infection or other serious condition that your doctor thinks would make you unable to participate.
• Patient cannot have a serious cardiac condition, such as a heart attack, angina, or heart disease within 6 months of entering the trial.
• Patient cannot have had a another form of cancer other than superficial basal cell and superficial squamous (skin) cell cancer, or carcinoma in situ of the cervix within the last 5 years.
• Patient cannot have had significant neurologic or psychiatric disorders including dementia, seizures and bipolar disorder.
• Patient cannot have moderate or severe peripheral neuropathy
• Patient cannot have received treatment within 30 days with any experimental drug.
• Patient cannot have had a major surgery within the last 4 weeks.
• Patient cannot have previously received treatment with transduction inhibitors or Epidermal Growth Factor Receptor (EGFR)-targeting therapy.
• Patient cannot have prior known allergic/hypersensitivity reaction to any of the components of study treatments.
• Females cannot be pregnant or breastfeeding.
• Patient is unable to stop taking more than 1.3 grams of aspirin on a daily basis or other aspirin like medication (non-steroidal antiinflammatory drugs: NSAIDs) for a few days during each cycle of therapy.
• Patient is unable or unwilling to take folic acid, injections of vitamin B12, or corticosteroids.
• Patient cannot have fluid around your lungs or in your abdomen (pleural effusions or ascites) that cannot be controlled by drainage or other procedures.
• Patient cannot have received a yellow fever vaccination within the previous 30 days or plan to have it.
• Patient cannot have known drug abuse.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Graz, , Austria

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Salzburg, , Austria

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Wels, , Austria

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Berlin, , Germany

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Halle, , Germany

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Homburg, , Germany

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Mannheim, , Germany

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Tübingen, , Germany

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Athens, , Greece

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Pátrai, , Greece

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Bari, , Italy

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Bergamo, , Italy

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Palermo, , Italy

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Potenza, , Italy

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Torino, , Italy

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Treviso, , Italy

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's-Hertogenbosch, , Netherlands

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Amsterdam, , Netherlands

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Groningen, , Netherlands

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Maastricht, , Netherlands

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Barcelona, , Spain

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Lleida, , Spain

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Madrid, , Spain

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Reus, , Spain

Countries

Austria; Germany; Greece; Italy; Netherlands; Spain

Other Identifiers

H3E-MC-S104

Identifier Type: OTHER

Identifier Source: secondary_id

10726

Identifier Type: -

Identifier Source: org_study_id