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Primary (safety) endpoint reached
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This single arm study will assess the feasibility of using Avastin plus platinum-based chemotherapy (cisplatin-gemcitabine or carboplatin-paclitaxel) in patients with advanced or recurrent squamous non-small cell lung cancer who have not received prior chemotherapy. Patients will receive preventive radiation, followed by one cycle of chemotherapy alone and 5 cycles of chemotherapy in combination with Avastin (15mg/kg iv on day 1 of each 3 weekly cycle), followed by Avastin alone for a maximum total treatment period with Avastin of 12 months. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bevacizumab [Avastin] | Drug | 15mg iv on day 1 of each 3 week cycle |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of grade >=3 Avastin-related pulmonary hemorrhage | After a maximum of 12 months treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response, duration of response, progression-free survival. | Event driven | |
| AEs, laboratory parameters, coagulation parameters. | Throughout study |
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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 |
|---|---|---|---|---|---|---|
| Tugun | Australia | |||||
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| Platinum-based chemotherapy |
| Drug |
As prescribed |
|
| Wollongong |
| Australia |
| Liège | Belgium |
| Ostrava | Czechia |
| Ústí nad Labem | Czechia |
| Bobigny | France |
| Marseille | France |
| Nantes | France |
| Székesfehérvár | Hungary |
| Szombathely | Hungary |
| Kfar Saba | Israel |
| Ramat Gan | Israel |
| Lublin | Poland |
| Poznan | Poland |
| Szczecin | Poland |
| Warsaw | Poland |
| Balashikha | Russia |
| Moscow | Russia |
| Saint Petersburg | Russia |
| Madrid | Spain |
| Seville | Spain |
| Kueishan | Taiwan |
| Taichung | Taiwan |
| Taipei | Taiwan |
| Taoyuan | Taiwan |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| 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 |
| D017671 | Platinum Compounds |
| 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 |
| D007287 | Inorganic Chemicals |
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