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| ID | Type | Description | Link |
|---|---|---|---|
| ML21896 |
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| Name | Class |
|---|---|
| Roche Pharma AG | INDUSTRY |
| Eli Lilly and Company | INDUSTRY |
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Multi-center, open, randomized (parallel) and comparative phase III.
Eligible patients will receive bevacizumab + chemotherapy for a minimum of 4 cycles followed by bevacizumab (+ pemetrexed, if appropriate) maintenance therapy until disease progression.
Arm A: Bevacizumab + pemetrexed
Arm B: Bevacizumab + pemetrexed + carboplatin
Primary:
Secondary:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bevacizumab + Pemetrexed | Active Comparator | Bevacizumab + Pemetrexed |
|
| Bevacizumab + Pemetrexed + Carboplatin | Active Comparator | Bevacizumab + Pemetrexed + Carboplatin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab + Pemetrexed | Drug | Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes every 3 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | Progression free survival (defined as the number of days from the day of the first treatment until day of death (from any cause) or progression, whichever occurs earlier, or until the day of the last response assessment, if no progression or death (from any cause) is observed during the study). | 42 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Overall survival (defined as the number of days from the day of first treatment to death (from any cause), or until the last day if we know that the patient is alive). | 42 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wolfgang Schuette, PhD MD. | Krankenhaus Martha-Maria Halle-Doelau | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Krankenhaus Martha-Maria Halle-Doelau | Halle | 06120 | Germany |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bevacizumab + Pemetrexed | Bevacizumab + Pemetrexed Bevacizumab + Pemetrexed: Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes every 3 weeks |
| FG001 | Bevacizumab + Pemetrexed + Carboplatin |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Bevacizumab + Pemetrexed + Carboplatin | Drug | Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes and carboplatin AUC 5 on D1 every 3 weeks |
|
|
Bevacizumab + Pemetrexed + Carboplatin Bevacizumab + Pemetrexed + Carboplatin: Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes and carboplatin AUC 5 on D1 every 3 weeks |
| COMPLETED |
|
| NOT COMPLETED |
|
|
271 patients were enrolled and randomized, due to Screening failure and subject withdrawn consent the intent-to-treat (ITT) population comprised 253 evaluable patients (BP n=119; BPC n=134).
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| ID | Title | Description |
|---|---|---|
| BG000 | Bevacizumab + Pemetrexed | Bevacizumab + Pemetrexed Bevacizumab + Pemetrexed: Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes every 3 weeks |
| BG001 | Bevacizumab + Pemetrexed + Carboplatin | Bevacizumab + Pemetrexed + Carboplatin Bevacizumab + Pemetrexed + Carboplatin: Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes and carboplatin AUC 5 on D1 every 3 weeks |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression Free Survival | Progression free survival (defined as the number of days from the day of the first treatment until day of death (from any cause) or progression, whichever occurs earlier, or until the day of the last response assessment, if no progression or death (from any cause) is observed during the study). | Posted | Median | 95% Confidence Interval | months | 42 months |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival | Overall survival (defined as the number of days from the day of first treatment to death (from any cause), or until the last day if we know that the patient is alive). | Posted | Median | 95% Confidence Interval | months | 42 months |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bevacizumab + Pemetrexed | Bevacizumab + Pemetrexed Bevacizumab + Pemetrexed: Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes every 3 weeks | 8 | 119 | 61 | 119 | ||
| EG001 | Bevacizumab + Pemetrexed + Carboplatin | Bevacizumab + Pemetrexed + Carboplatin Bevacizumab + Pemetrexed + Carboplatin: Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes and carboplatin AUC 5 on D1 every 3 weeks | 7 | 134 | 97 | 134 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| anaemia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Dr. Wolfgang Schuette | Krankenhaus Martha-Maria Halle-Doelau gGmbH | +49 345 5591440 | wolfgang.schuette@martha-maria.de |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D000068437 | Pemetrexed |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000600 | Amino Acids, Dicarboxylic |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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| Male |
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