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Recruiting
NCT06862869
Real World Clinical Outcomes of Resected ALK-Positive Early Stage NSCLC Patients Treated With Alectinib as Adjuvant Therapy
Conditions: Carcinoma, Non-Small-Cell Lung
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 800
Sponsor: Hoffmann-La Roche
Location: Affiliated Hospital of Guangdong Medical University Zhanjiang Guangdong
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT06862869). StuddyBuddy aggregates publicly available trial information.