A Study to See How Well and How Safely Different Treatments Work in a Group of Participants With Non-Small Cell Lung Cancer (NSCLC)

A Phase I-II, Multicenter Study Evaluating the Efficacy and Safety of Multiple Therapies in Cohorts of Patients With Resectable Stage I-III Non-Small Cell Lung Cancer, Selected According to Biomarker Status

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.

Inclusion Criteria:

• Complete resection of the primary NSCLC with negative margins
• Confirmed stage II to select stage IIIB (T3N2) NSCLC of non-squamous (adenocarcinoma) histology
• Eastern cooperative oncology group (ECOG) performance status of 0 or 1
• Documented ALK fusion

Exclusion Criteria:

• NSCLC of squamous or mixed histology regardless of the presence of an ALK mutation
• Prior exposure to any systemic anti-cancer therapy
• Pregnancy or breastfeeding, or intention of becoming pregnant during the study