Conditions: Non-Small Cell Lung Cancer
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 134
Healthy volunteers: no

Brief summary:
This non-randomized, open-label, multicenter study will evaluate the safety and efficacy of alectinib in participants with ALK-rearranged non-small cell lung cancer who failed crizotinib treatment. In Phase I, cohorts of participants will receive escalating doses of alectinib orally twice daily. In Phase II, patients who failed crizotinib treatment will receive the recommended phase II dose.

Detailed description:

Arms:
arm 1: Participants will receive escalating doses of alectinib capsules orally until disease progression, death or withdrawal for any other reasons. arm 2: Participants will receive recommended Phase II dose as determined from Phase I until disease progression, death or withdrawal for any other reasons.

Interventions: intervention 1: Alectinib
Intervention descriptions: intervention 1: Participants will receive alectinib as described in the arm descriptions.

Protocol document: