A Study of Induction and Maintenance Treatment of Advanced Non-squamous Non-Small Cell Lung Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00789373
First received: November 10, 2008
Last updated: May 30, 2014
Last verified: May 2014
Results First Received: June 20, 2011  
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: Cisplatin
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
No text entered.

Reporting Groups
  Description
Induction Pemetrexed + Cisplatin

pemetrexed: 500 mg/m^2, intravenous (IV), on Day 1 of each 21-day cycle for 4 cycles.

cisplatin: 75 mg/m^2, IV, on Day 1 of each 21-day cycle for 4 cycles.

Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed Following Induction, received 500 mg/m^2 maintenance pemetrexed, IV, on Day 1 of each 21-day cycle plus Best Supportive Care until progressive disease (PD) or treatment discontinuation.
Pemetrexed + Cisplatin Followed by Placebo Following Induction, received placebo (normal saline [0.9% sodium chloride]) administered IV on Day 1 of every 21-day cycle plus Best Supportive Care until PD or treatment discontinuation.

Participant Flow for 2 periods

Period 1:   Induction
    Induction Pemetrexed + Cisplatin     Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed     Pemetrexed + Cisplatin Followed by Placebo  
STARTED     939     0     0  
COMPLETED     540 [1]   0     0  
NOT COMPLETED     399     0     0  
Adverse Event                 64                 0                 0  
Death Due to study disease                 24                 0                 0  
Death due to adverse event                 19                 0                 0  
Death due to toxicity                 11                 0                 0  
Death due to procedure                 1                 0                 0  
Investigator decision                 7                 0                 0  
Protocol entry criteria not met                 9                 0                 0  
Lost to Follow-up                 6                 0                 0  
Protocol Violation                 1                 0                 0  
Progressive Disease                 220                 0                 0  
Withdrawal by Subject                 37                 0                 0  
[1] 1 patient received maintenance therapy post-induction but was never randomized.

Period 2:   Maintenance
    Induction Pemetrexed + Cisplatin     Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed     Pemetrexed + Cisplatin Followed by Placebo  
STARTED     0     359     180  
COMPLETED     0     0     0  
NOT COMPLETED     0     359     180  
Adverse Event                 0                 65                 12  
Death due to study disease                 0                 3                 1  
Death due to adverse event                 0                 4                 1  
Death due to toxicity                 0                 1                 2  
Investigator Decision                 0                 4                 2  
Protocol entry criteria not met                 0                 2                 0  
Lost to Follow-up                 0                 2                 0  
Progressive Disease                 0                 253                 152  
Withdrawal by Subject                 0                 21                 8  
Sponsor Decision                 0                 0                 2  
Participants On-Going at Data Cut-Off                 0                 4                 0  



  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.
No text entered.

Reporting Groups
  Description
Induction Pemetrexed + Cisplatin pemetrexed plus cisplatin

Baseline Measures
    Induction Pemetrexed + Cisplatin  
Number of Participants  
[units: participants]
  939  
Age  
[units: years]
Median ( Full Range )
  61.3  
  ( 24.4 to 83.0 )  
Gender  
[units: participants]
 
Female     362  
Male     577  
Race/Ethnicity, Customized  
[units: participants]
 
Asian     59  
African     7  
Multiple     2  
Caucasian     871  
Region of Enrollment  
[units: participants]
 
Portugal     38  
Greece     34  
Finland     18  
Spain     65  
Turkey     33  
United Kingdom     71  
Italy     175  
India     54  
France     106  
Poland     34  
Belgium     53  
Romania     55  
Australia     26  
Netherlands     48  
Germany     126  
Canada     3  
Smoking Status  
[units: participants]
 
Ever Smoker     757  
Never Smoker     175  
Unknown     7  



  Outcome Measures
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1.  Primary:   Investigator-assessed Objective Progression-free Survival (PFS)   [ Time Frame: Date of randomization to the date of measured PD or date of death from any cause (up to 19.3 months) ]

2.  Secondary:   Independently-assessed Objective Progression-free Survival (PFS)   [ Time Frame: Date of randomization to first date of measured PD or date of death from any cause (up to 19.3 months) ]

3.  Secondary:   Overall Survival (OS)   [ Time Frame: Date of randomization to the date of death from any cause up to 39.5 months ]

4.  Secondary:   Change From Baseline in the EuroQol Instrument (EQ-5D) Index Score   [ Time Frame: Baseline randomization through 30-day post-discontinuation visit (up to 19.3 months) ]

5.  Secondary:   Change From Baseline in EuroQol Instrument (EQ-5D) Visual Analog Scale (VAS)   [ Time Frame: Baseline randomization through 30-day post-discontinuation visit (up to 19.3 months) ]

6.  Secondary:   Percentage of Participants With Hospitalizations Due to Adverse Events or Requiring Transfusion (Resource Utilization)   [ Time Frame: Baseline randomization through 30-day post-discontinuation visit (up to 19.3 months) ]

7.  Secondary:   Percentage of Participants With a Non-Serious Adverse Event (AE) During Maintenance Phase   [ Time Frame: Baseline randomization through 30-day post-discontinuation visit (up to 49.7 months) ]

8.  Secondary:   Percentage of Participants With Serious Adverse Events During Maintenance Phase   [ Time Frame: Baseline randomization through 30-day post-discontinuation visit (up to 49.7 months) ]

9.  Secondary:   Percentage of Participants With Objective Tumor Response (Response Rate) During Maintenance Phase of Study up to Primary Data Cut-Off   [ Time Frame: Baseline to date of measured progressive disease (up to 19.3 months) ]

10.  Secondary:   Percentage of Participants With Independently-Assessed Objective Tumor Response (Response Rate) During Maintenance Phase Up to Primary Data Cut-Off   [ Time Frame: Date of randomization to date of measured PD (up to 19.3 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
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  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


No publications provided by Eli Lilly and Company

Publications automatically indexed to this study:


Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00789373     History of Changes
Other Study ID Numbers: 12560, H3E-EW-S124, CTRI/2009/091/000113
Study First Received: November 10, 2008
Results First Received: June 20, 2011
Last Updated: May 30, 2014
Health Authority: United States: Food and Drug Administration