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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
Enrollment 150
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pemetrexed Alone Pemetrexed Plus Matuzumab 800 mg Per Week Pemetrexed Plus Matuzumab 1600 mg Every 3 Weeks
Hide Arm/Group Description 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. 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. 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.
Period Title: Overall Study
Started 50 51 49
Treated 50 51 47
Completed 2 5 0
Not Completed 48 46 49
Reason Not Completed
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
Arm/Group Title Pemetrexed Alone Pemetrexed Plus Matuzumab 800 mg Per Week Pemetrexed Plus Matuzumab 1600 mg Every 3 Weeks Total
Hide Arm/Group Description Participants received pemetrexed 50 mg/m^2 IV infusion every 3 weeks until PD or the occurrence of unacceptable toxicity. 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. 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 of all reporting groups
Overall Number of Baseline Participants 50 51 47 148
Hide Baseline Analysis Population Description
Intent to treat (ITT) population included all randomized participants who received at least one infusion of study treatment.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 50 participants 51 participants 47 participants 148 participants
61
(37 to 83)
62
(48 to 81)
63
(46 to 78)
62
(37 to 83)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 51 participants 47 participants 148 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%
1.Primary Outcome
Title Number of Participants With Objective Response Assessed by Independent Review Committee
Hide Description Objective response was defined as having a complete response (CR) or a partial response (PR). Response assessment was performed using modified World Health Organization (WHO) criteria. Complete response: disappearance of all index and non-index lesions, without appearance of any new lesion. PR: greater than (>) 50 percent (%) decrease from baseline in sum of product of diameters of index lesions, without appearance of any new lesion.
Time Frame Baseline up to PD or death due to any cause (up to approximately 2 years)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Pemetrexed Alone Pemetrexed Plus Matuzumab 800 mg Per Week Pemetrexed Plus Matuzumab 1600 mg Every 3 Weeks
Hide Arm/Group Description:
Participants received pemetrexed 50 mg/m^2 IV infusion every 3 weeks until PD or the occurrence of unacceptable toxicity.
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.
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.
Overall Number of Participants Analyzed 50 51 47
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: participants
2
(1 to 14)
8
(7 to 29)
1
(0 to 11)
2.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS was defined as the duration from randomization to death (due to any cause). OS was estimated using Kaplan-Meier analysis.
Time Frame Baseline up to PD or death due to any cause (up to approximately 3.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Pemetrexed Alone Pemetrexed Plus Matuzumab 800 mg Per Week Pemetrexed Plus Matuzumab 1600 mg Every 3 Weeks
Hide Arm/Group Description:
Participants received pemetrexed 50 mg/m^2 IV infusion every 3 weeks until PD or the occurrence of unacceptable toxicity.
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.
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.
Overall Number of Participants Analyzed 50 51 47
Median (95% Confidence Interval)
Unit of Measure: months
7.9
(7.2 to 9.9)
12.4 [1] 
(8.8 to NA)
5.9
(3.6 to 7.2)
[1]
The upper limit of 95% confidence interval (CI) could not be estimated due to insufficient number of participants with event (death).
3.Secondary Outcome
Title Progression-Free Survival (PFS)
Hide Description PFS was defined as the time from randomization to the first documentation of disease progression (PD) or to death due to any cause, whichever occurred first. PD: >25% increase in one or more lesions, or appearance new lesions. PFS was estimated using Kaplan-Meier analysis.
Time Frame Baseline up to PD or death due to any cause (up to approximately 3.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Pemetrexed Alone Pemetrexed Plus Matuzumab 800 mg Per Week Pemetrexed Plus Matuzumab 1600 mg Every 3 Weeks
Hide Arm/Group Description:
Participants received pemetrexed 50 mg/m^2 IV infusion every 3 weeks until PD or the occurrence of unacceptable toxicity.
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.
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.
Overall Number of Participants Analyzed 50 51 47
Median (95% Confidence Interval)
Unit of Measure: months
2.7
(1.6 to 4.4)
2.3
(1.5 to 3.8)
2.5
(1.4 to 2.9)
4.Secondary Outcome
Title Duration of Objective Response Assessed by Independent Review Committee
Hide Description Objective response was defined as having a CR or a PR. Response assessment was performed using modified WHO criteria. CR: disappearance of all index and non-index lesions, without appearance of any new lesion. PR: >50% decrease from baseline in sum of product of diameters of index lesions, without appearance of any new lesion. Duration of objective response was defined as time from first appearance of CR or PR to time of PD (>25% increase in one or more lesions, or appearance new lesions) or death. Duration of objective response was to be assessed using Kaplan-Meier analysis.
Time Frame From first documented objective response to PD or death due to any cause (up to approximately 3.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Pemetrexed Alone Pemetrexed Plus Matuzumab 800 mg Per Week Pemetrexed Plus Matuzumab 1600 mg Every 3 Weeks
Hide Arm/Group Description:
Participants received pemetrexed 50 mg/m^2 IV infusion every 3 weeks until PD or the occurrence of unacceptable toxicity.
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.
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.
Overall Number of Participants Analyzed 50 51 47
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Data could not be estimated due to higher number (>50%) of censored participants.
5.Secondary Outcome
Title Change From Baseline to Cycle 2 in Global Quality of Life (QoL), as Assessed Using Lung Cancer Symptom Scale (LCSS)
Hide Description The LCSS consisted of 9 items: 6 items focused on lung cancer symptoms (loss of appetite, fatigue, cough, dyspnea, hemoptysis, and pain] and 3 items were global items (symptom distress, interference with activity level, and global QoL). The global QoL item scores are reported here. The total global QoL item score ranged from 0 (worse QoL) to 100 (best QoL).
Time Frame Baseline, Cycle 2 (Cycle length = 3 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Here, overall number of participants analyzed = participants with available data for this outcome; number analyzed = participants with available data at specified timepoint.
Arm/Group Title Pemetrexed Alone Pemetrexed Plus Matuzumab 800 mg Per Week Pemetrexed Plus Matuzumab 1600 mg Every 3 Weeks
Hide Arm/Group Description:
Participants received pemetrexed 50 mg/m^2 IV infusion every 3 weeks until PD or the occurrence of unacceptable toxicity.
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.
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.
Overall Number of Participants Analyzed 45 46 44
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 45 participants 46 participants 44 participants
35.9  (26.0) 31.1  (25.8) 35.8  (27.5)
Change at Cycle 2 Number Analyzed 26 participants 25 participants 24 participants
3.5  (17.2) 0.8  (19.9) 15.7  (30.7)
Time Frame [Not Specified]
Adverse Event Reporting Description Among SAEs, data for total # affected by any SAE and total # affected by febrile neutropenia are only available. Due diligence was done and all potential information sources have been exhausted; no further information could be retrieved. Hence, for other participants preferred term "Not Available" and System Organ Class "General Disorders" is used.
 
Arm/Group Title Pemetrexed Alone Pemetrexed Plus Matuzumab 800 mg Per Week Pemetrexed Plus Matuzumab 1600 mg Every 3 Weeks
Hide Arm/Group Description Participants received pemetrexed 50 mg/m^2 IV infusion every 3 weeks until PD or the occurrence of unacceptable toxicity. 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. 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.
All-Cause Mortality
Pemetrexed Alone Pemetrexed Plus Matuzumab 800 mg Per Week Pemetrexed Plus Matuzumab 1600 mg Every 3 Weeks
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Pemetrexed Alone Pemetrexed Plus Matuzumab 800 mg Per Week Pemetrexed Plus Matuzumab 1600 mg Every 3 Weeks
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   9/50 (18.00%)   5/51 (9.80%)   11/47 (23.40%) 
Blood and lymphatic system disorders       
Febrile neutropenia * 1  1/50 (2.00%)  1/51 (1.96%)  3/47 (6.38%) 
General disorders       
 * 1  8/50 (16.00%)  4/51 (7.84%)  8/47 (17.02%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 9.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pemetrexed Alone Pemetrexed Plus Matuzumab 800 mg Per Week Pemetrexed Plus Matuzumab 1600 mg Every 3 Weeks
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   8/50 (16.00%)   20/51 (39.22%)   18/47 (38.30%) 
Blood and lymphatic system disorders       
Neutropenia * 1  6/50 (12.00%)  11/51 (21.57%)  7/47 (14.89%) 
Lymphopenia * 1  0/50 (0.00%)  1/51 (1.96%)  5/47 (10.64%) 
Leukopenia * 1  1/50 (2.00%)  3/51 (5.88%)  3/47 (6.38%) 
Thrombocytopenia * 1  0/50 (0.00%)  1/51 (1.96%)  3/47 (6.38%) 
General disorders       
Fatigue * 1  1/50 (2.00%)  4/51 (7.84%)  1/47 (2.13%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 9.0
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.
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
Layout table for Results Point of Contact information
Name/Title: Merck KGaA Communication Center
Organization: Merck Serono, a division of Merck KGaA
Phone: 496151725200
EMail: service@merckgroup.com
Layout table for additonal information
Responsible Party: EMD Serono
ClinicalTrials.gov Identifier: NCT00111839    
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