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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: March 10, 2016
Last verified: March 2016
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 
Overall Participants Analyzed 
[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


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


Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00789373     History of Changes
Other Study ID Numbers: 12560
H3E-EW-S124 ( Other Identifier: Eli Lilly and Company )
CTRI/2009/091/000113 ( Registry Identifier: India )
Study First Received: November 10, 2008
Results First Received: June 20, 2011
Last Updated: March 10, 2016
Health Authority: United States: Food and Drug Administration