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

Recruiting

• Conditions: Carcinoma, Non-Small-Cell Lung
• Interventions: Drug: Alectinib

• Registration Number: NCT06862869
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-20
• Study First Submitted QC: 2025-03-03
• Study First Posted: 2025-03-06
• Study Start: 2025-03-26
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-07
• Last Update Posted: 2025-05-08
• Primary Completion: 2029-03-30
• Study Completion: 2029-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 800

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 1	Alectinib	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Duration of alectinib therapy	From start of treatment to the date of treatment discontinuation (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
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)
Incidence and severity of adverse events (AEs)	Baseline to withdrawal from study or 28 days after the last dose of alectinib, whichever occurs first

Trial Locations

Locations (1)

Shanghai Pulmonary Hospital; 🇨🇳 Shanghai, China