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The objective of this study is to explore the safety of alectinib in combination with chemotherapy in participants with resectable NSCLC. Cohort B1 is a phase II cohort that will assess the safety of alectinib in combination with up to four cycles of platinum-based chemotherapy in the adjuvant setting post complete surgical resection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort B1 | Experimental | Participants will receive alectinib in combination with a platinum-based chemotherapy for up to 4 cycles (cycle length = 3 weeks), followed by alectinib monotherapy for up to 2 years. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alectinib | Drug | Participants will receive oral alectinib twice daily (BID) for up to 2 years. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence, Type, and Severity of Adverse Events (AEs) With Onset up to 28 Days After the Last Dose of Chemotherapy | Up to 28 days after the last dose of chemotherapy treatment (up to 4 cycles, cycle length = 3 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence, Type, and Severity of AEs With Onset up to 28 Days After the Last Dose of Study Treatment or Until Last on Site/Discontinuation Visit, Whichever Comes First | From first dose to up to approximately 2 years |
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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 |
|---|---|---|---|---|---|---|
| Royal North Shore Hospital | St Leonards | New South Wales | 2065 | Australia | ||
| Sir Charles Gairdner Hospital |
For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
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| Cisplatin |
| Drug |
Participants will receive intravenous (IV) cisplatin on Day 1 of each cycle for up to 4 cycles (cycle length = 3 weeks). |
|
| Carboplatin | Drug | Participants will receive IV carboplatin on Day 1 of each cycle for up to 4 cycles (cycle length = 3 weeks). |
|
| Pemetrexed | Drug | Participants will receive IV pemetrexed on Day 1 of each cycle for up to 4 cycles (cycle length = 3 weeks). |
|
| Nedlands |
| Western Australia |
| 6009 |
| Australia |
| Instituto do Cancer do Estado de Sao Paulo - ICESP | São Paulo | São Paulo | 01246-000 | Brazil |
| RedSalud Vitacura | Santiago | Chile |
| Beijing Cancer Hospital | Beijing | 100142 | China |
| The third people's hospital of Chengdu | Chengdu | China |
| Guangdong General Hospital | Guangzhou | 510000 | China |
| Jinhua municipal central hospital | Jinhua | China |
| Yunnan Cancer Hospital | Kunming | 650118 | China |
| Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia | Perugia | Umbria | 06156 | Italy |
| Asan Medical Center | Seoul | 05505 | South Korea |
| 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 |
|---|---|
| C582670 | alectinib |
| D002945 | Cisplatin |
| D016190 | Carboplatin |
| D000068437 | Pemetrexed |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| 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 |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
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