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A Study in Non-squamous Non Small Cell Lung Cancer in Asian Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01020786
First received: November 24, 2009
Last updated: August 2, 2012
Last verified: February 2012
History of Changes
Results First Received: January 12, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Non Small Cell Lung Cancer
Interventions: Drug: Pemetrexed
Drug: Carboplatin

  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

Induction period: pemetrexed and carboplatin were administered for 4 cycles (1 cycle=21 days). Participants with documented complete response (CR), partial response (PR), or stable disease (SD) entered the maintenance therapy period (fifth cycle and after).

Maintenance period: pemetrexed monotherapy until a discontinuation criterion was met.

Reporting Groups
  Description
Pemetrexed + Carboplatin

Induction therapy period (Pemetrexed + carboplatin): 500 milligrams per square meter (mg/m^2) of pemetrexed given intravenously (IV) on Day 1 of every 21-day cycle for 4 cycles.

Carboplatin: dosage equal to the area under the curve (AUC)6 milligrams per milliliter per minute (mg/mL/min) for participant, given IV on Day 1 of every 21-day cycle for 4 cycles.

Maintenance therapy period (pemetrexed monotherapy): 500 mg/m^2 of pemetrexed given IV on Day 1 of every 21-day cycle until disease progression or unacceptable toxicity.

Participant Flow for 2 periods

 Period 1:   Induction Period
    Pemetrexed + Carboplatin  
STARTED     109  
COMPLETED     60 [1]
NOT COMPLETED     49  
Entry Criteria Not Met                 2  
Adverse Event                 9  
Progressive Disease                 31  
Investigator Decision                 3  
Withdrawal by Subject                 4  
[1] Completed induction therapy. Completed=starting the maintenance therapy.

Period 2:   Maintenance Period
    Pemetrexed + Carboplatin  
STARTED     60  
COMPLETED     9 [1]
NOT COMPLETED     51  
Adverse Event                 8  
Progressive Disease                 38  
Withdrawal by Subject                 5  
[1] Continuing study treatment.



  Baseline Characteristics
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Reporting Groups
  Description
Pemetrexed + Carboplatin

Induction therapy period (Pemetrexed + carboplatin): 500 milligrams per square meter (mg/m^2) of pemetrexed given intravenously (IV) on Day 1 of every 21-day cycle for 4 cycles.

Carboplatin: dosage equal to the area under the curve (AUC)6 milligrams per milliliter per minute (mg/mL/min) for participant, given IV on Day 1 of every 21-day cycle for 4 cycles.

Maintenance therapy period (pemetrexed monotherapy): 500 mg/m^2 of pemetrexed given IV on Day 1 of every 21-day cycle until disease progression or unacceptable toxicity.

Baseline Measures
    Pemetrexed + Carboplatin  
Number of Participants  
[units: participants]
 		  109  
Age  
[units: years]
Mean ± Standard Deviation 		  63.35  ± 8.692  
Gender  
[units: participants]
 		 
Female     40  
Male     69  
Race/Ethnicity, Customized  
[units: participants]
 		 
Japanese     109  
Region of Enrollment  
[units: participants]
 		 
Japan     109  
Percentage of Participants in Each Smoking Status Category at Study Entry [1]
[units: percentage of participants]
 		 
Current Smoker     8.3  
Former Smoker     61.5  
Never Smoker     30.3  
Unknown     0.0  
Percentage of Participants in Each Histology Category [2]
[units: percentage of participants]
 		 
Adenocarcinoma Lung     96.3  
Large Cell Lung Carcinoma     2.8  
Carcinoma, Non-small Cell, Lung Not Otherwise S     0.9  
Percentage of Participants in Each Disease Stage [3]
[units: percentage of participants]
 		 
Stage IIIb     30.3  
Stage IV     66.1  
Other     3.7  
Percentage of Participants in Each Epidermal Growth Factor Receptor (EGFR) Mutation Status Category [4]
[units: percentage of participants]
 		 
Positive     22.0  
Negative     57.8  
Unknown     2.8  
Not Done     17.4  
Percentage of Participants in Each Eastern Cooperative Oncology Group (ECOG) Status [5]
[units: percentage of participants]
 		 
0 - Fully Active     33.9  
1 - Ambulatory, Restricted Strenuous Activity     66.1  
[1] Percentage of participants in each category for smoking status. All of the percentages do not add up to 100% because of rounding.
[2] Percentage of participants in each of the following categories: adenocarcinoma, large cell lung carcinoma, and carcinoma, non-small cell, lung not otherwise specified (NOS).
[3] Percentage of participants in each disease stage category. Stage means how big the tumor is and how far it has spread. Stages range from 0 (not spread) to IV (spread throughout the body. Stage IIIB - cancer spread to opposite side of chest, more than 1 tumor within same lobe of lung; Stage IV - the cancer has spread to other organs of the body such as the other lung, brain, or liver. All of the percentages do not add up to 100% because of rounding.
[4] Percentage of participants in each EGFR mutation status category.
[5]

ECOG Performance Status (PS). Classifies participants according to their functional impairment. Scores range from 0 (Fully Active) to 5 (Death).

0 - Fully Active

  1. - Ambulatory, Restricted Strenuous Activity
  2. - Ambulatory, No Work Activities
  3. - Partially Confined to Bed, Limited Self Care
  4. - Completely Disabled
  5. - Death



  Outcome Measures
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1.  Primary:   Progression Free Survival (PFS) During the Induction and Maintenance Therapy Periods   [ Time Frame: Enrollment to the date of progressive disease (PD) or the date of death from any cause (up to 18 months) ]
  Show Outcome Measure 1

2.  Secondary:   Overall Survival (OS) During the Induction and Maintenance Therapy Periods   [ Time Frame: Enrollment to the date of death from any cause (up to 2 years) ]
  Show Outcome Measure 2

3.  Secondary:   Percentage of Participants Who Achieve a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) During the Induction and Maintenance Therapy Periods   [ Time Frame: Enrollment to date of progressive disease (up to 18 months) ]
  Show Outcome Measure 3

4.  Secondary:   Percentage of Participants Who Achieved a Complete Response (CR) or Partial Response (PR) During the Induction and Maintenance Therapy Periods   [ Time Frame: Enrollment to date of progressive disease (up to 18 months) ]
  Show Outcome Measure 4

5.  Secondary:   Progression Free Survival (PFS) During the Maintenance Therapy Period   [ Time Frame: From the start of maintenance therapy in Cycle 5 (21-day cycle) until the date of measured progressive disease (PD) or death from any cause (up to 18 months) ]
  Show Outcome Measure 5

6.  Secondary:   Overall Survival (OS) During the Maintenance Therapy Period   [ Time Frame: From the start of maintenance therapy in Cycle 5 (21-day cycle) until the date of measured progressive disease (PD) or death from any cause (up to 2 years) ]
  Show Outcome Measure 6

7.  Secondary:   Percentage of Participants Who Achieved a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) During the Maintenance Therapy Period   [ Time Frame: From the start of maintenance therapy in Cycle 5 (21-day cycle) until the date of measured progressive disease (PD) or death from any cause (up to 18 months) ]
  Show Outcome Measure 7

8.  Secondary:   Percentage of Participants Who Observe a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) During the Induction Therapy Period   [ Time Frame: Enrollment to the date of PD, or end of induction period up to Cycle 4 (21-day cycle) ]
  Show Outcome Measure 8

9.  Secondary:   Percentage of Participants Who Achieve a Complete Response (CR) or a Partial Response (PR) During the Induction Therapy Period   [ Time Frame: Enrollment to date of PD, or end of induction period up to Cycle 4 (21-day cycle) ]
  Show Outcome Measure 9


  Serious Adverse Events
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  Other Adverse Events
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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.


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.  


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: NCT01020786     History of Changes
Other Study ID Numbers: 12628, H3E-JE-JMII
Study First Received: November 24, 2009
Results First Received: January 12, 2012
Last Updated: August 2, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare
Japan: Pharmaceuticals and Medical Devices Agency