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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
11
Participants will receive oral alectinib twice daily (BID) for up to 2 years.
Participants will receive intravenous (IV) cisplatin on Day 1 of each cycle for up to 4 cycles (cycle length = 3 weeks).
Participants will receive IV carboplatin on Day 1 of each cycle for up to 4 cycles (cycle length = 3 weeks).
Royal North Shore Hospital
St Leonards, New South Wales, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia
Instituto do Cancer do Estado de Sao Paulo - ICESP
São Paulo, São Paulo, Brazil
Incidence, Type, and Severity of Adverse Events (AEs) With Onset up to 28 Days After the Last Dose of Chemotherapy
Time frame: Up to 28 days after the last dose of chemotherapy treatment (up to 4 cycles, cycle length = 3 weeks)
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
Time frame: From first dose to up to approximately 2 years
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Participants will receive IV pemetrexed on Day 1 of each cycle for up to 4 cycles (cycle length = 3 weeks).
RedSalud Vitacura
Santiago, Chile
Beijing Cancer Hospital
Beijing, China
The third people's hospital of Chengdu
Chengdu, China
Guangdong General Hospital
Guangzhou, China
Jinhua municipal central hospital
Jinhua, China
Yunnan Cancer Hospital
Kunming, China
Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia
Perugia, Umbria, Italy
...and 1 more locations