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Study of Pemetrexed Versus Pemetrexed Plus Erlotinib as Treatment of Nonsquamous Non-Small Cell Lung Cancer (NSCLC)

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ClinicalTrials.gov Identifier: NCT00447057
Recruitment Status : Completed
First Posted : March 13, 2007
Results First Posted : October 13, 2011
Last Update Posted : October 13, 2011
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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Brief Summary:
This is a multicenter, randomized, Phase 2, open label, parallel trial to evaluate an effect of pemetrexed alone on nonsquamous non-small cell lung cancer (NSCLC) in a second-line setting (such as progression-free survival [PFS], disease control rate, best response rate, time to treatment failure [TTTF], overall survival [OS] and 1-year survival rates) compared to pemetrexed plus erlotinib combination.

Condition or disease Intervention/treatment Phase
Histological or Cytological Diagnosis of Locally Advanced or Metastatic NSCLC of Nonsquamous Histology and Not Amenable to Curative Therapy. Drug: Pemetrexed Drug: Erlotinib Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 204 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase 2 Study of Pemetrexed Versus Pemetrexed Plus Erlotinib in Second-Line Treatment in Patients With Nonsquamous NSCLC
Study Start Date : March 2007
Actual Primary Completion Date : July 2010
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: Pemetrexed (Nonsquamous)
Group of participants with non-small cell lung cancer (NSCLC) of nonsquamous histology who were assigned to Pemetrexed arm
 Drug: Pemetrexed
500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21-day cycle until disease progression (PD) or unacceptable toxicity
Other Names:
  • LY231514
  • Alimta
Experimental: Pemetrexed + Erlotinib (Nonsquamous)
Group of participants with NSCLC of nonsquamous histology who were assigned to Pemetrexed + Erlotinib arm
 Drug: Erlotinib
150 mg given orally (po), daily (QD), starting on the first day of the first cycle
Other Name: Tarceva
Drug: Pemetrexed
500 mg/m² iv over 10 minutes on the first day of each 21-day cycle until PD or unacceptable toxicity
Other Names:
  • LY231514
  • Alimta
Experimental: Pemetrexed (Squamous)
Group of participants with NSCLC of squamous histology who were assigned to Pemetrexed arm
 Drug: Pemetrexed
500 mg/m² iv over 10 minutes on the first day of each 21-day cycle until PD or unacceptable toxicity
Other Names:
  • LY231514
  • Alimta
Experimental: Pemetrexed + Erlotinib (Squamous)
Group of participants with NSCLC of squamous histology who were assigned to Pemetrexed + Erlotinib arm
 Drug: Pemetrexed
500 mg/m² iv over 10 minutes on the first day of each 21-day cycle until PD or unacceptable toxicity
Other Names:
  • LY231514
  • Alimta
Drug: Erlotinib
150 mg given po, QD, starting on the first day of the first cycle
Other Name: Tarceva


Outcome Measures
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Primary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: Baseline to date of measured PD or death from any cause. Maximum follow-up was from baseline to 32.2 months ]
    PFS per Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 criteria using computed tomography (CT) or magnetic resonance imaging (MRI) for objective determination of progressive disease (PD: ≤20% increase in sum of longest diameter of target lesion). For participants alive as of data cut-off date who did not have PD, PFS was censored at date of last CT/MRI. For participants who received subsequent systemic anticancer therapy (after study discontinuation) prior to PD or death, PFS censored at date of last CT/MRI prior to initiation of post discontinuation systemic anticancer therapy.


Secondary Outcome Measures :
  1. Percentage of Participants With Best Response of Stable Disease (SD), Partial Response (PR) or Complete Response (CR) (Disease Control Rate) [ Time Frame: Baseline to measured PD. Maximum follow-up was from Baseline to 34 months ]

    Per RECIST:

    CR: Disappearance of all target lesions; PR: Either a) ≤30% decrease in sum of longest diameter (LD) of target lesions or b) complete disappearance of target lesions, with persistence (but not worsening) of ≥1 nontarget lesions. In either case, no new lesions may have appeared.

    SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.

    PD: ≤20% increase in sum of LD of target lesions. Disease Control Rate (%) = (SD+PR+CR)/number of participants in arm*100.


  2. Percentage of Participants With Best Response of Complete Response (CR) or Partial Response (PR) (Response Rate) [ Time Frame: Baseline to measured progressive disease. Maximum follow-up was from Baseline to 34 months ]

    CR: Disappearance of all tumor lesions; PR: Either a) at least a 30% decrease in sum of LD of target lesions or b) complete disappearance of target lesions, with persistence (but not worsening) ≥1 nontarget lesions. In either case, no new lesions may have appeared.

    SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.

    PD: ≤20% increase in the sum of LD of target lesions. Response Rate (%) = (CR+PR)/number of participants in arm*100.


  3. Time to Treatment Failure (TTTF) [ Time Frame: Baseline to first date among death from any cause, PD, or study treatment discontinuation for any reason other than "protocol complete" or "satisfactory response". Maximum follow-up was from Baseline to 32.2 months ]
    Defined as the time from randomization to death from any cause, first observation of PD, or study treatment discontinuation due to any reason other than "protocol complete" or "satisfactory response". For participants who discontinued due to "protocol complete" or "satisfactory response", or for participants not known to have discontinued as of the data cut-off date, TTTF was censored at the last contact date.

  4. Overall Survival (OS) [ Time Frame: Baseline to date of death from any cause. Maximum follow-up was from Baseline to 42.6 months. ]
    OS time is the duration from randomization to the date of death from any cause. For each participant who was not known to have died as of the data inclusion cut-off date, OS was censored at the date of last contact.

  5. Percentage of Participants Surviving at 1 Year [ Time Frame: Baseline to date of death from any cause up to 1 year ]
    Overall Survival (OS) rate at 1 year from the date of randomization was determined using the distribution of OS times and was estimated using the Kaplan-Meier method.

  6. Number of Participants With Adverse Events (AEs) [ Time Frame: Baseline up to 42.2 months ]
    Summaries of serious AEs (SAEs) and all other non-serious AEs are located in the Reported Adverse Event Module.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histological or cytological diagnosis of locally advanced or metastatic NSCLC that is of nonsquamous histology and not amenable to curative therapy.
  • Failure of previous treatment with one prior platinum-based chemotherapy regimen.
  • Good performance status.
  • Adequate bone marrow reserve, renal and hepatic functions.

Exclusion Criteria:

  • Serious concomitant systemic disease.
  • Inability to take oral medication.
  • Inability or unwillingness to take vitamin supplementation and corticosteroids.
  • Pregnancy / Breast-feeding.
  • Treatment with certain medicines that prevent blood from clotting.
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): NCT00447057


Locations
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, 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.
Vienna, Austria, A-1140
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.
Bochum, Germany, 44791
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.
Freiburg, Germany, 79106
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.
Gauting, Germany, 82131
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Gerlingen, Germany, 70839
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.
Hamburg, Germany, D 21075
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Hannover, Germany, 30625
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.
Immenhausen, Germany, 34376
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Trier, Germany, 54219
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.
Tübingen, Germany, 72076
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.
Ulm, Germany, 89075
Hungary
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.
Deszk, Hungary, 6772
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Matrahaza, Hungary, 3233
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.
Nyiregyhaza, Hungary, H-4400
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.
Szekesfehervar, Hungary, 8000
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.
Alicante, Spain, 03010
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, 08036
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, 28050
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.
Valencia, Spain, 46010
Sweden
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.
Linkoping, Sweden, 58185
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.
Lund, Sweden, 221 85
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.
Solna, Sweden, 17176
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Lilly Clinical Trial Registry  This link exits the ClinicalTrials.gov site

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00447057     History of Changes
Other Study ID Numbers: 10721
H3E-MC-S102 ( Other Identifier: Eli Lilly and Company )
First Posted: March 13, 2007    Key Record Dates
Results First Posted: October 13, 2011
Last Update Posted: October 13, 2011
Last Verified: September 2011

Keywords provided by Eli Lilly and Company:
nonsquamous

Additional relevant MeSH terms:
Erlotinib Hydrochloride
Pemetrexed
Antineoplastic Agents
Protein Kinase Inhibitors
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors