This study is a multicenter, prospective, cohort study designed to evaluate the clinical outcomes and characteristics of resected stage II-IIIB anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) adult patients treated with Alectinib as adjuvant therapy in China.
Study Type
OBSERVATIONAL
Enrollment
800
Participants will have received alectinib adjuvant treatment for resected stage II-IIIB ALK-positive NSCLC in routine clinical practice. NOTE: No intervention will be provided in this study as the study is observational.
Real-world disease-free survival (rwDFS)
Time frame: From baseline to the date of the first documentation of cancer recurrence, as determined by the physician according to local clinical standard of care, or death due to any cause, whichever occurs first (up to approximately 2.5 years)
Duration of alectinib therapy
Time frame: From start of treatment to the date of treatment discontinuation (up to approximately 2.5 years)
Participant demographics by disease stage and city tier
Time frame: Up to approximately 2.5 years
Participant clinical characteristics as determined by Eastern Cooperative Oncology Group performance status (ECOG PS) by disease stage and city tier
Time frame: Up to approximately 2.5 years
Participant clinical characteristics as determined by surgery history by disease stage and city tier
Time frame: Up to approximately 2.5 years
Emotional and physical functioning as determined by the 36-item short form survey (SF-36) v2 questionnaires
Time frame: At enrollment, then every approximately 3 months thereafter (up to approximately 2.5 years)
Incidence and severity of adverse events (AEs)
Time frame: Baseline to withdrawal from study or 28 days after the last dose of alectinib, whichever occurs first
Reference Study ID Number: ML45766 https://forpatients.roche.com/ No attachments to email below.
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