A Study Comparing Two Different Chemotherapy Types in Chinese Patients With Advanced Non Small Cell Lung Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01005680
First received: October 29, 2009
Last updated: October 18, 2013
Last verified: October 2013
Results First Received: October 18, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Non Small Cell Lung Cancer
Interventions: Drug: Pemetrexed
Drug: Gemcitabine
Drug: Cisplatin

  Participant Flow
  Hide Participant Flow

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
Pemetrexed Plus Cisplatin (PC)

Pemetrexed: 500 milligrams/square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles

Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles

Gemcitabine Plus Cisplatin (GC)

Gemcitabine: 1250 mg/m² administered intravenously on Day 1 and Day 8 of each 21-day cycle, for 6 cycles

Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles


Participant Flow:   Overall Study
    Pemetrexed Plus Cisplatin (PC)     Gemcitabine Plus Cisplatin (GC)  
STARTED     126     130  
Received at Least 1 Dose of Study Drug     125     127  
COMPLETED     120     119  
NOT COMPLETED     6     11  
Lost to Follow-up                 4                 6  
Withdrawal by Subject                 1                 4  
Physician Decision                 1                 1  



  Baseline Characteristics
  Hide Baseline Characteristics

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.
All randomized participants.

Reporting Groups
  Description
Pemetrexed Plus Cisplatin (PC)

Pemetrexed: 500 milligrams/square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles

Cisplatin: 75 mg/m² administered intravenously on day 1 of each 21-day cycle, for 6 cycles

Gemcitabine Plus Cisplatin (GC)

Gemcitabine: 1250 mg/m² administered intravenously on Day 1 and day 8 of each 21-day cycle, for 6 cycles

Cisplatin: 75 mg/m² administered intravenously on day 1 of each 21 day cycle, for 6 cycles

Total Total of all reporting groups

Baseline Measures
    Pemetrexed Plus Cisplatin (PC)     Gemcitabine Plus Cisplatin (GC)     Total  
Number of Participants  
[units: participants]
  126     130     256  
Age  
[units: years]
Mean ± Standard Deviation
  56.6  ± 10.65     55.7  ± 9.95     56.1  ± 10.29  
Gender  
[units: participants]
     
Female     55     59     114  
Male     71     71     142  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     0     0     0  
Not Hispanic or Latino     126     130     256  
Unknown or Not Reported     0     0     0  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     126     130     256  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     0     0     0  
White     0     0     0  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
China     126     130     256  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Overall Survival (OS)   [ Time Frame: Randomization to date of death from any cause up to 35.8 months post-randomization ]

2.  Secondary:   Progression Free Survival (PFS)   [ Time Frame: Randomization to first date of Progressive Disease (PD) or death from any cause up to 33.0 months post-randomization ]

3.  Secondary:   Time to Progressive Disease (TtPD)   [ Time Frame: Randomization to first date of PD up to 23.7 months post-randomization ]

4.  Secondary:   Duration of Response (DoR)   [ Time Frame: Date of first response to the date of (PD) or death from any cause up to 22.9 months post-randomization ]

5.  Secondary:   Time to Treatment Failure (TtTF)   [ Time Frame: Randomization until date of discontinuation of study treatment due to adverse events, PD, or death from any cause up to 6.3 months post-randomization ]

6.  Secondary:   Tumor Response Rate   [ Time Frame: Randomization until date of objective PD or death from any cause up to 35.8 months post-randomization ]

7.  Secondary:   Risk/Benefit Ratio   [ Time Frame: Randomization to date of death from any cause up to 35.8 months post-randomization ]

8.  Other Pre-specified:   Disease Control Rate (DCR)   [ Time Frame: Randomization to date of objective PD or death from any cause up to 35.8 months post-randomization ]

9.  Other Pre-specified:   Survival Without Toxicity (SWT)   [ Time Frame: Randomization to date of toxicity or date of death up to 34.6 months post-randomization ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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


Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01005680     History of Changes
Other Study ID Numbers: 12878, H3E-CR-JMIL
Study First Received: October 29, 2009
Results First Received: October 18, 2013
Last Updated: October 18, 2013
Health Authority: China: Food and Drug Administration