Real World Clinical Outcomes of Resected ALK-Positive Early Stage NSCLC Patients Treated With Alectinib as Adjuvant Therapy

Roche

Status: Enrolling

Conditions: Carcinoma, Non-Small-Cell Lung

Treatments: Drug: Alectinib

Study type: Observational

Funder types: Industry

Identifiers

NCT06862869

ML45766

Details and patient eligibility

About

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.

Enrollment: 800 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

800 participants in 1 patient group

Cohort 1

Description:

Participants with resected stage II-IIIB ALK-positive NSCLC who have received Alectinib adjuvant therapy will be followed-up for approximately 2.5 years during routine visits at real-world clinical practice settings.

Treatment:

Drug: Alectinib