Carcinoma, Non-Small-Cell Lung
Conditions
Brief summary
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.
Interventions
DRUGAlectinib
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.
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically-confirmed stage II-IIIA or selected IIIB (T3N2) NSCLC as per the American Joint Committee on Cancer and International Union Against Cancer (UICC/AJCC), 8th edition * ALK positive * Postoperative NSCLC patients who have undergone complete resection * Had taken Alectinib monotherapy without prior systemic therapy (including other ALK-TKIs or chemotherapy) as adjuvant† therapy for resected stage II-IIIB ALKpositive NSCLC and the time from the first dose to enrollment was no more than 28 days
Exclusion criteria
* Patients participating in interventional study of adjuvant treatment * Pregnant, lactating, or breastfeeding women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Real-world disease-free survival (rwDFS) | 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) |
Secondary
| Measure | Time frame |
|---|---|
| Incidence and severity of adverse events (AEs) | Baseline to withdrawal from study or 28 days after the last dose of alectinib, whichever occurs first |
| Emotional and physical functioning as determined by the 36-item short form survey (SF-36) v2 questionnaires | At enrollment, then every approximately 3 months thereafter (up to approximately 2.5 years) |
| Participant demographics by disease stage and city tier | 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 | Up to approximately 2.5 years |
| Participant clinical characteristics as determined by surgery history by disease stage and city tier | Up to approximately 2.5 years |
| Duration of alectinib therapy | From start of treatment to the date of treatment discontinuation (up to approximately 2.5 years) |
Countries
China
Contacts
CONTACTReference Study ID Number: ML45766 https://forpatients.roche.com/ No attachments to email below.
CONTACTFastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
STUDY_DIRECTORClinical Trials
Hoffmann-La Roche
Outcome results
None listed