Clinical Trial TitleA phase III, open-label, randomized study to evaluate the efficacy and safety of adjuvant alectinib versus adjuvant platinum-based chemotherapy in patients with completely resected stage IB to stage IIIA anaplastic lymphoma kinase-positive NSCLC.
Clinical Trial Protocol Description:
This randomized, active-controlled, multi-center, open-label, phase III study is designed to compare the effects, good or bad, of alectinib versus platinum-based chemotherapy for patients with a specific type of lung cancer. Participants in the experimental arm will receive alectinib at 600 mg orally twice daily for 24 months. Participants in the control arm will receive a platinum based chemotherapy regimen for 4 cycles. Following treatment completion, participants will be followed until disease recurrence.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are at least 18 yearsof age.
- Have complete resection of histologically confirmed stage IB (tumor ≥ 4 cm) to stage IIIA (T2-3 N0, T1-3 N1, T1-3 N2, T4 N0-1) non-small cell lung cancer.
- Have documented ALK-positive disease.
You will be excluded from the study if any of the following criteria apply to you:
- Have had prior adjuvant radiotherapy or exposure to systemic chemotherapy and ALK inhibitors.
- Are a stage IIIA N2 patient that, in the investigator's opinion, should receive post-operative radiotherapy treatment.
This is a partial list of inclusion and exclusion criteria.