A Phase 2 interventional study of Pemetrexed and Matuzumab in Lung Cancer and Non Small Cell Lung Carcinoma, sponsored by EMD Serono. Completed at 58 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-04-06.
Sponsored by EMD Serono · Phase 2, Interventional, and Treatment
This open-label, multicenter, randomized, controlled, Phase II study is planned to answer questions about how the drug, matuzumab (EMD 72000), works and is part of an effort aimed to develop better treatment for advanced lung cancer by combining matuzumab, a monoclonal antibody, with a chemotherapy treatment, called pemetrexed.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 150 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →EMD Serono is the lead sponsor of 88 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive 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.
Drug: Pemetrexed
Participants will receive pemetrexed 50 mg/m\^2 IV infusion every 3 weeks in combination with matuzumab 800 milligrams (mg) IV infusion once every week. Treatment will continue until PD or the occurrence of unacceptable toxicity.
Drug: Pemetrexed · Drug: Matuzumab
Participants will receive pemetrexed 50 mg/m\^2 IV infusion every 3 weeks in combination with matuzumab 1600 mg IV infusion every 3 weeks. Treatment will continue until PD or the occurrence of unacceptable toxicity.
Drug: Pemetrexed · Drug: Matuzumab
Pemetrexed will be administered IV until PD or the occurrence of unacceptable toxicity.
Matuzumab will be administered IV until PD or the occurrence of unacceptable toxicity.
Number of Participants With Objective Response Assessed by Independent Review Committee
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)
Overall Survival (OS)
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)
Progression-Free Survival (PFS)
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)
Duration of Objective Response Assessed by Independent Review Committee
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)
Change From Baseline to Cycle 2 in Global Quality of Life (QoL), as Assessed Using Lung Cancer Symptom Scale (LCSS)
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)
| Milestone | 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 |
| Withdrew: Disease progression | 30 | 33 | 33 |
| Withdrew: Adverse event | 5 | 3 | 1 |
| Withdrew: Protocol violation | 2 | 4 | 2 |
| Withdrew: Death | 1 | 1 | 6 |
| Withdrew: Withdrawal by subject | 2 | 2 | 2 |
| Withdrew: Lost to follow-up | 1 | 0 | 0 |
| Withdrew: Logistical constraint | 1 | 0 | 0 |
| Withdrew: Other | 6 | 3 | 3 |
| Withdrew: Randomized but not treated | 0 | 0 | 2 |
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.
| participants | Pemetrexed Alone | Pemetrexed Plus Matuzumab 800 mg Per Week | Pemetrexed Plus Matuzumab 1600 mg Every 3 Weeks |
|---|---|---|---|
| Number of Participants With Objective Response Assessed by Independent Review Committee | 2 (1 to 14) | 8 (7 to 29) | 1 (0 to 11) |
OS was defined as the duration from randomization to death (due to any cause). OS was estimated using Kaplan-Meier analysis.
| months | Pemetrexed Alone | Pemetrexed Plus Matuzumab 800 mg Per Week | Pemetrexed Plus Matuzumab 1600 mg Every 3 Weeks |
|---|---|---|---|
| Overall Survival (OS) | 7.9 (7.2 to 9.9) | 12.4 (8.8 to NA) | 5.9 (3.6 to 7.2) |
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.
| months | Pemetrexed Alone | Pemetrexed Plus Matuzumab 800 mg Per Week | Pemetrexed Plus Matuzumab 1600 mg Every 3 Weeks |
|---|---|---|---|
| Progression-Free Survival (PFS) | 2.7 (1.6 to 4.4) | 2.3 (1.5 to 3.8) | 2.5 (1.4 to 2.9) |
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.
| months | Pemetrexed Alone | Pemetrexed Plus Matuzumab 800 mg Per Week | Pemetrexed Plus Matuzumab 1600 mg Every 3 Weeks |
|---|---|---|---|
| Duration of Objective Response Assessed by Independent Review Committee | NA (NA to NA) | NA (NA to NA) | NA (NA to NA) |
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).
| units on a scale | Pemetrexed Alone | Pemetrexed Plus Matuzumab 800 mg Per Week | Pemetrexed Plus Matuzumab 1600 mg Every 3 Weeks |
|---|---|---|---|
| Baseline | 35.9 ± 26.0 | 31.1 ± 25.8 | 35.8 ± 27.5 |
| Change at Cycle 2 | 3.5 ± 17.2 | 0.8 ± 19.9 | 15.7 ± 30.7 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pemetrexed Alone | — | 9/50 (18%) | 8/50 (16%) |
| Pemetrexed Plus Matuzumab 800 mg Per Week | — | 5/51 (9.8%) | 20/51 (39.2%) |
| Pemetrexed Plus Matuzumab 1600 mg Every 3 Weeks | — | 11/47 (23.4%) | 18/47 (38.3%) |
| Event | Pemetrexed Alone | Pemetrexed Plus Matuzumab 800 mg Per Week | Pemetrexed Plus Matuzumab 1600 mg Every 3 Weeks |
|---|---|---|---|
| Febrile neutropeniaBlood and lymphatic system disorders | 1/50 | 1/51 | 3/47 |
| Event | Pemetrexed Alone | Pemetrexed Plus Matuzumab 800 mg Per Week | Pemetrexed Plus Matuzumab 1600 mg Every 3 Weeks |
|---|---|---|---|
| NeutropeniaBlood and lymphatic system disorders | 6/50 | 11/51 | 7/47 |
| LymphopeniaBlood and lymphatic system disorders | 0/50 | 1/51 | 5/47 |
| FatigueGeneral disorders | 1/50 | 4/51 | 1/47 |
| LeukopeniaBlood and lymphatic system disorders | 1/50 | 3/51 | 3/47 |
| ThrombocytopeniaBlood and lymphatic system disorders | 0/50 | 1/51 | 3/47 |
Intent to treat (ITT) population included all randomized participants who received at least one infusion of study treatment.
| Age, Continuous(years) | Pemetrexed Alone | Pemetrexed Plus Matuzumab 800 mg Per Week | Pemetrexed Plus Matuzumab 1600 mg Every 3 Weeks | Total |
|---|---|---|---|---|
| Median | 61 (37 to 83) | 62 (48 to 81) | 63 (46 to 78) | 62 (37 to 83) |
| Sex: Female, Male(Participants) | Pemetrexed Alone | Pemetrexed Plus Matuzumab 800 mg Per Week | Pemetrexed Plus Matuzumab 1600 mg Every 3 Weeks | Total |
|---|---|---|---|---|
| Female | 17 | 16 | 20 | 53 |
| Male | 33 | 35 | 27 | 95 |
This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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EMD Serono