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

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ClinicalTrials.gov Identifier: NCT00867009
Recruitment Status : Completed
First Posted : March 23, 2009
Results First Posted : May 16, 2012
Last Update Posted : June 15, 2015
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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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.

Condition or disease Intervention/treatment Phase
Non-Small-Cell Lung Cancer Drug: Pemetrexed Drug: Cisplatin Drug: Cetuximab Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 113 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of Pemetrexed and Cisplatin Plus Cetuximab Followed by Pemetrexed and Cetuximab Maintenance Therapy in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (Stage IIIB or IV) Other Than Predominantly Squamous Cell Histology
Study Start Date : April 2009
Actual Primary Completion Date : May 2011
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Induction/maintenance Therapy
pemetrexed, cisplatin and cetuximab followed by pemetrexed and cetuximab
 Drug: 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
Other Names:
  • Alimta
  • LY231514

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

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


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants With a Tumor Response (Objective Tumor Response Rate) [ Time Frame: From start of treatment until documented best response. (up to 18.9 months) ]
    Response was assessed using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=30% decrease in sum of longest diameter of target lesions. Tumor response is presented as a percentage (%) and is the number of participants with a CR plus PR divided by the number of participants in the protocol qualified (PQ) population, then multiplied by 100.


Secondary Outcome Measures :
  1. Progression-free Survival (PFS) [ Time Frame: From start of treatment until documented disease progression or death from any cause (up to 18.9 months) ]
    PFS is measured from study entry until disease progression, death or date of last contact. Progressive disease (PD) was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD = 20% increase in sum of longest diameter of target lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. For participants not known to have died or have had objective PD as of the data cutoff date, PFS was censored at the date of the last objective progression-free disease assessment.

  2. The Percentage of Participants Still Living at One Year (One Year Survival Rate) [ Time Frame: One year ]
    The one year survival rate is presented as percentage (%) of participants still living at one year and is the number of participants that are still alive at one year divided by the number of participants in the protocol qualified (PQ) population, which is then multiplied by 100.

  3. The Percentage of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD) (Disease Control Rate [DCR]) [ Time Frame: From start of treatment until documented best tumor response (up to 18.9 months) ]
    The DCR is presented as percentage (%) and is the number of participants with a best tumor response of CR, PR, or SD divided by the number of participants in the protocol qualified (PQ) population, then multiplied by 100. Best tumor response of CR, PR, or SD was determined from the sequence of tumor response assessments. Tumor response was assessed using RECIST criteria. CR=disappearance of all target lesions; PR=30% decrease in sum of longest diameter of target lesions; SD=small changes that do not meet above criteria.


Eligibility Criteria
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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00867009


Locations
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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.
Graz, Austria, 8036
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, 5020
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, 4600
Germany
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, 13125
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.
Halle, Germany, D-06120
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.
Homburg, Germany, 66421
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.
Mannheim, Germany, 68167
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.
Tuebingen, Germany, 72076
Greece
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.
Athens, Greece, 11527
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.
Patras, Greece, 26500
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.
Bari, Italy, 70126
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, 24128
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.
Palermo, Italy, 90146
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, 85028
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.
Torino, Italy, 10100
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.
Treviso, Italy, 31100
Netherlands
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.
Amsterdam, Netherlands, 1081 HV
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.
Groningen, Netherlands, 9713 GZ
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.
Maastricht, Netherlands, 6229 HX
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.
S-Hertogenbosch, Netherlands, 5211 NL
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.
Barcelona, Spain, 08003
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, 25198
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, 28034
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, 43201
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: 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
More Information
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00867009    
Other Study ID Numbers: 10726
H3E-MC-S104 ( Other Identifier: Eli Lilly and Company )
First Posted: March 23, 2009    Key Record Dates
Results First Posted: May 16, 2012
Last Update Posted: June 15, 2015
Last Verified: September 2014
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
 Cisplatin
Pemetrexed
Cetuximab
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors
Antineoplastic Agents, Immunological