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Effects of Matuzumab in Combination With Pemetrexed for the Treatment of Advanced Lung Cancer

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ClinicalTrials.gov Identifier: NCT00111839
Recruitment Status : Completed
First Posted : May 27, 2005
Results First Posted : April 6, 2018
Last Update Posted : April 6, 2018
Sponsor:
Information provided by (Responsible Party):
EMD Serono

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Lung Cancer
Non Small Cell Lung Carcinoma
Interventions: Drug: Pemetrexed
Drug: Matuzumab

  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 Alone Participants received pemetrexed 50 milligrams per square meter (mg/m^2) intravenous (IV) infusion every 3 weeks until disease progression (PD) or the occurrence of unacceptable toxicity.
Pemetrexed Plus Matuzumab 800 mg Per Week Participants received pemetrexed 50 mg/m^2 IV infusion every 3 weeks in combination with matuzumab 800 mg IV infusion once every week. An observation period of at least 1 hour was specified between the end of the matuzumab infusion and the start of pemetrexed administration when these treatments were given on the same day. Treatment was continued until PD or the occurrence of unacceptable toxicity.
Pemetrexed Plus Matuzumab 1600 mg Every 3 Weeks Participants received pemetrexed 50 mg/m^2 IV infusion every 3 weeks in combination with matuzumab 1600 mg IV infusion every 3 weeks. An observation period of at least 1 hour was specified between the end of the matuzumab infusion and the start of pemetrexed administration when these treatments were given on the same day. Treatment was continued until PD or the occurrence of unacceptable toxicity.

Participant Flow:   Overall Study
    Pemetrexed Alone   Pemetrexed Plus Matuzumab 800 mg Per Week   Pemetrexed Plus Matuzumab 1600 mg Every 3 Weeks
STARTED   50   51   49 
Treated   50   51   47 
COMPLETED   2   5   0 
NOT COMPLETED   48   46   49 
Disease Progression                30                33                33 
Adverse Event                5                3                1 
Protocol Violation                2                4                2 
Death                1                1                6 
Withdrawal by Subject                2                2                2 
Lost to Follow-up                1                0                0 
Logistical Constraint                1                0                0 
Other                6                3                3 
Randomized but Not Treated                0                0                2 



  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.
Intent to treat (ITT) population included all randomized participants who received at least one infusion of study treatment.

Reporting Groups
  Description
Pemetrexed Alone Participants received pemetrexed 50 mg/m^2 IV infusion every 3 weeks until PD or the occurrence of unacceptable toxicity.
Pemetrexed Plus Matuzumab 800 mg Per Week Participants received pemetrexed 50 mg/m^2 IV infusion every 3 weeks in combination with matuzumab 800 mg IV infusion once every week. An observation period of at least 1 hour was specified between the end of the matuzumab infusion and the start of pemetrexed administration when these treatments were given on the same day. Treatment was continued until PD or the occurrence of unacceptable toxicity.
Pemetrexed Plus Matuzumab 1600 mg Every 3 Weeks Participants received pemetrexed 50 mg/m^2 IV infusion every 3 weeks in combination with matuzumab 1600 mg IV infusion every 3 weeks. An observation period of at least 1 hour was specified between the end of the matuzumab infusion and the start of pemetrexed administration when these treatments were given on the same day. Treatment was continued until PD or the occurrence of unacceptable toxicity.
Total Total of all reporting groups

Baseline Measures
   Pemetrexed Alone   Pemetrexed Plus Matuzumab 800 mg Per Week   Pemetrexed Plus Matuzumab 1600 mg Every 3 Weeks   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 50   51   47   148 
Age 
[Units: Years]
Median (Full Range) 		 61 
 (37 to 83)  		 62 
 (48 to 81)  		 63 
 (46 to 78)  		 62 
 (37 to 83) 
Sex: Female, Male 
[Units: Participants]
Count of Participants 		       
Female      17  34.0%      16  31.4%      20  42.6%      53  35.8% 
Male      33  66.0%      35  68.6%      27  57.4%      95  64.2% 


  Outcome Measures

1.  Primary:   Number of Participants With Objective Response Assessed by Independent Review Committee   [ Time Frame: Baseline up to PD or death due to any cause (up to approximately 2 years) ]
  Show Outcome Measure 1

2.  Secondary:   Overall Survival (OS)   [ Time Frame: Baseline up to PD or death due to any cause (up to approximately 3.5 years) ]
  Show Outcome Measure 2

3.  Secondary:   Progression-Free Survival (PFS)   [ Time Frame: Baseline up to PD or death due to any cause (up to approximately 3.5 years) ]
  Show Outcome Measure 3

4.  Secondary:   Duration of Objective Response Assessed by Independent Review Committee   [ Time Frame: From first documented objective response to PD or death due to any cause (up to approximately 3.5 years) ]
  Show Outcome Measure 4

5.  Secondary:   Change From Baseline to Cycle 2 in Global Quality of Life (QoL), as Assessed Using Lung Cancer Symptom Scale (LCSS)   [ Time Frame: Baseline, Cycle 2 (Cycle length = 3 weeks) ]
  Show Outcome Measure 5


  Serious Adverse Events


  Other Adverse Events


  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
For serious adverse events (SAEs), due diligence was done and all potential information sources have been exhausted, no further information could be retrieved apart from what is currently reported.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Merck KGaA Communication Center
Organization: Merck Serono, a division of Merck KGaA
phone: 496151725200
e-mail: service@merckgroup.com


Publications of Results:


Responsible Party: EMD Serono
ClinicalTrials.gov Identifier: NCT00111839     History of Changes
Other Study ID Numbers: EMD 72000-031
2006-000899-32 ( EudraCT Number )
First Submitted: May 26, 2005
First Posted: May 27, 2005
Results First Submitted: August 24, 2017
Results First Posted: April 6, 2018
Last Update Posted: April 6, 2018