Pemetrexed and Best Supportive Care Versus Placebo and Best Supportive Care in Non-Small Cell Lung Cancer (NSCLC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00102804
First received: February 1, 2005
Last updated: December 17, 2014
Last verified: December 2014
Results First Received: December 17, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Non-Small Cell Lung Cancer
Interventions: Drug: Pemetrexed
Drug: Placebo
Other: Best Supportive Care

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants who signed the informed consent form (ICF) and completed the randomized process are presented in the participant flow by the treatment arm to which they were randomized. Participants who did not sign the ICF or complete the randomization process were removed from the database and excluded from all analyses.

Reporting Groups
  Description
Pemetrexed and BSC

Pemetrexed: 500 milligrams per square meter (mg/m^2), intravenous (IV) administration, every (q) 21 days, until disease progression.

Best Supportive Care (BSC): Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician.

Placebo and BSC

Placebo: IV administration, q 21 days, until disease progression.

BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician.


Participant Flow:   Overall Study
    Pemetrexed and BSC     Placebo and BSC  
STARTED     441     222  
Received at Least 1 Dose of Study Drug     434     222 [1]
COMPLETED     0     0  
NOT COMPLETED     441     222  
Progressive Disease (PD)                 307                 196  
Withdrawal by Subject                 46                 7  
Adverse Event                 37                 3  
Physician Decision                 24                 6  
Death                 5                 6  
Enrollment Criteria Not Met                 6                 0  
Lost to Follow-up                 4                 1  
Protocol Violation                 2                 1  
Satisfactory Response                 2                 0  
Sponsor Decision                 1                 0  
Alive, Receiving Treatment                 7                 2  
[1] Four participants randomized to placebo received pemetrexed.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who signed the ICF and completed the randomized process are reported according to the treatment arm to which they were randomized.

Reporting Groups
  Description
Pemetrexed and BSC

Pemetrexed: 500 mg/m^2, IV administration, q 21 days, until disease progression.

BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician.

Placebo and BSC

Placebo: IV administration, q 21 days.

BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician.

Total Total of all reporting groups

Baseline Measures
    Pemetrexed and BSC     Placebo and BSC     Total  
Number of Participants  
[units: participants]
  441     222     663  
Age  
[units: years]
Median (Inter-Quartile Range)
  60.6  
  (54.3 to 67.5)  
  60.4  
  (53.8 to 67.0)  
  60.6  
  (54.1 to 67.4)  
Gender  
[units: participants]
     
Female     119     61     180  
Male     322     161     483  
Race/Ethnicity, Customized  
[units: participants]
     
Aboriginal     0     1     1  
African     6     0     6  
Caucasian     279     149     428  
East Asian     104     50     154  
Hispanic     13     6     19  
West Asian     39     16     55  
Region of Enrollment  
[units: participants]
     
United States     20     12     32  
Taiwan     5     4     9  
Greece     18     9     27  
Spain     30     19     49  
Turkey     7     4     11  
Austria     2     2     4  
Italy     18     16     34  
India     39     16     55  
Hungary     8     6     14  
Czech Republic     5     2     7  
Poland     25     11     36  
Brazil     24     10     34  
Croatia     10     3     13  
Romania     51     26     77  
Australia     19     8     27  
Bulgaria     11     8     19  
Netherlands     10     4     14  
Germany     40     16     56  
China     62     37     99  
Korea, Republic of     37     9     46  



  Outcome Measures
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1.  Primary:   Progression-Free Survival (PFS) Time   [ Time Frame: Randomization to measured PD or death from any cause (up to 41 months) ]

2.  Secondary:   Overall Survival (OS) Time   [ Time Frame: Randomization to date of death from any cause (up to 41 months) ]

3.  Secondary:   Time to Objective Progressive Disease (TPD)   [ Time Frame: Randomization to measured PD (up to 41 months) ]

4.  Secondary:   Time to Worsening of Symptoms (TWS)   [ Time Frame: Randomization to worsening of each LCSS item (up to 39 months) ]

5.  Secondary:   Percentage of Participants With a Complete Response (CR) or Partial Response (PR) (Objective Tumor Response Rate)   [ Time Frame: Baseline to measured PD (up to 41 months) ]

6.  Secondary:   Number of Participants With Adverse Events (AEs)   [ Time Frame: Baseline to study completion (up to 41 Months) ]

7.  Secondary:   Maximum Improvement Over Baseline in Individual Symptom Scores and Quality of Life Using the LCSS   [ Time Frame: Baseline through 30 days post discontinuation of study treatment (up to 39 Months) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Four participants (pts) assigned to placebo received pemetrexed; pts analyzed for efficacy as randomized. Three treated pts did not sign ICF, 1 treated pt signed ICF but did not complete entire randomization process; pts excluded from all analyses.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 800-545-5979


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00102804     History of Changes
Other Study ID Numbers: 5122
H3E-MC-JMEN ( Other Identifier: Eli Lilly and Company )
Study First Received: February 1, 2005
Results First Received: December 17, 2014
Last Updated: December 17, 2014
Health Authority: United States: Food and Drug Administration