Clinical trial · Observational
Real World Clinical Outcomes of Resected ALK-Positive Early Stage NSCLC Patients Treated With Alectinib as Adjuvant Therapy
Real World Clinical Outcomes of Resected ALK-Positive Early Stage NSCLC Patients Treated With Alectinib as Adjuvant Therapy in China: A Multicenter, Prospective Cohort Study
NCT06862869CI-TRIAL-00120940recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 9, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260909-000002
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Alectinib | Drug | Alectinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- 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.
- interventionNames
- Drug: Alectinib
Primary outcomes (1)
- measure
- Real-world disease-free survival (rwDFS)
- timeFrame
- 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 outcomes (6)
- measure
- Duration of alectinib therapy
- timeFrame
- From start of treatment to the date of treatment discontinuation (up to approximately 2.5 years)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.