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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-018945-72 |
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This open label, 2-part study will evaluate the safety and efficacy of RO5083945 in combination with standard chemotherapy in patients with advanced or recurrent non-small cell lung cancer who have not received prior chemotherapy. In Part 1 patients will receive RO5083945 intravenously and standard chemotherapy (cisplatin plus either gemcitabine or pemetrexed) for up to 6 cycles of 3 weeks and then RO5083945 until disease progression. In Part 2 patients will be randomized to receive either RO5083945 in combination with standard chemotherapy or chemotherapy alone for up to 6 cycles. In the absence of disease progression, patients receiving RO503945 can continue treatment with RO5083945 as monotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A non-squamous | Experimental |
| |
| A squamous | Experimental |
| |
| B non-squamous | Active Comparator |
| |
| B squamous | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO5083945 | Drug | intravenously, until disease progression |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Part 2: Progression-free survival, according to RECIST criteria by CT/MRI | 23 months | |
| Part 1: Adverse event profile: adverse events, ECG, hematology, urinalysis, human anti-human antibodies (HAHA) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of RO5083945 (AUC, Cmax and Cmin) in combination with cisplatin and gemcitabine/pemetrexed | multiple sampling cycles 1-6 (18 weeks) | |
| Duration of response, according to RECIST criteria by CT/MRI | from response to disease progression |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charleroi | B6000 | Belgium | ||||
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| cisplatin |
| Drug |
standard treatment, up to 6 cycles |
|
| gemcitabine | Drug | standard treatment, up to 6 cycles |
|
| pemetrexed | Drug | standard treatment, up to 6 cycles |
|
| Clinical benefit rate (complete response, partial response or stable disease for >/=6 weeks), according to RECIST criteria by CT/MRI | 23 months |
| Overall survival | 23 months |
| Overall response rate (ORR), according to RECIST criteria by CT/MRI | 23 months |
| Leuven |
| 3000 |
| Belgium |
| Liège | 4000 | Belgium |
| Caen | 14033 | France |
| Marseille | 13915 | France |
| Saint-Herblain | 44805 | France |
| Toulouse | 31400 | France |
| Bad Berka | 99437 | Germany |
| Cologne | 51109 | Germany |
| Gauting | 82131 | Germany |
| Großhansdorf | 22927 | Germany |
| Heidelberg | 69126 | Germany |
| Mainz | 55131 | Germany |
| Mannheim | 68167 | Germany |
| Milan | Lombardy | 20132 | Italy |
| Milan | Lombardy | 20162 | Italy |
| Ancona | The Marches | Italy |
| Lido di Camaiore | Tuscany | 55043 | Italy |
| Livorno | Tuscany | 57100 | Italy |
| Perugia | Umbria | 06156 | Italy |
| Lodz | 93-509 | Poland |
| Otwock | 05-400 | Poland |
| Warsaw | 02-781 | Poland |
| Barcelona | Barcelona | 08003 | Spain |
| Barcelona | Barcelona | 08035 | Spain |
| Madrid | Madrid | 28040 | Spain |
| Madrid | Madrid | 28041 | Spain |
| Madrid | Madrid | 28046 | Spain |
| Madrid | Madrid | 28050 | Spain |
| Málaga | Malaga | 29010 | Spain |
| Seville | Sevilla | 41013 | Spain |
| London | SE1 9RT | United Kingdom |
| ID | Term |
|---|---|
| C569293 | imgatuzumab |
| D002945 | Cisplatin |
| D000093542 | Gemcitabine |
| D000068437 | Pemetrexed |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
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