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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00447057
First received: March 9, 2007
Last updated: September 12, 2011
Last verified: September 2011
  Purpose

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 Intervention 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 Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: No ]

    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.


  • 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 ] [ Designated as safety issue: No ]

    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.


  • 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 ] [ Designated as safety issue: No ]
    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.

  • Overall Survival (OS) [ Time Frame: Baseline to date of death from any cause. Maximum follow-up was from Baseline to 42.6 months. ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Surviving at 1 Year [ Time Frame: Baseline to date of death from any cause up to 1 year ] [ Designated as safety issue: No ]
    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.

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


Enrollment: 204
Study Start Date: March 2007
Study Completion Date: June 2011
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
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Vienna, Austria, A-1140
Germany
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Bochum, Germany, 44791
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Freiburg, Germany, 79106
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Gauting, Germany, 82131
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Gerlingen, Germany, 70839
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Hamburg, Germany, D 21075
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Hannover, Germany, 30625
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Immenhausen, Germany, 34376
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Trier, Germany, 54219
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Tübingen, Germany, 72076
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Ulm, Germany, 89075
Hungary
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Deszk, Hungary, 6772
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Matrahaza, Hungary, 3233
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Nyiregyhaza, Hungary, H-4400
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Szekesfehervar, Hungary, 8000
Spain
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Alicante, Spain, 03010
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Barcelona, Spain, 08036
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Madrid, Spain, 28050
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Valencia, Spain, 46010
Sweden
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Linkoping, Sweden, 58185
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Lund, Sweden, 221 85
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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

Additional Information:
No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00447057     History of Changes
Other Study ID Numbers: 10721, H3E-MC-S102
Study First Received: March 9, 2007
Results First Received: June 17, 2011
Last Updated: September 12, 2011
Health Authority: Austria: Agency for Health and Food Safety
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Spain: Ministry of Health

Keywords provided by Eli Lilly and Company:
nonsquamous

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Pemetrexed
Erlotinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Antimetabolites, Antineoplastic
Antimetabolites
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on July 22, 2014