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Recruiting NCT06862869

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

— Observational Carcinoma, Non-Small-Cell Lung

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Alectinib.
Who it may be relevant to
Registry conditions: Carcinoma, Non-Small-Cell Lung. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Drug Alectinib
    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.

Primary outcome measures

  • Real-world disease-free survival (rwDFS) [Time frame: 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 (6)
  • Duration of alectinib therapy [Time frame: From start of treatment to the date of treatment discontinuation (up to approximately 2.5 years)]
  • Participant demographics by disease stage and city tier [Time frame: 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 [Time frame: Up to approximately 2.5 years]
  • Participant clinical characteristics as determined by surgery history by disease stage and city tier [Time frame: Up to approximately 2.5 years]
  • Emotional and physical functioning as determined by the 36-item short form survey (SF-36) v2 questionnaires [Time frame: At enrollment, then every approximately 3 months thereafter (up to approximately 2.5 years)]
  • Incidence and severity of adverse events (AEs) [Time frame: Baseline to withdrawal from study or 28 days after the last dose of alectinib, whichever occurs first]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 44 centers
  • Affiliated Hospital of Guangdong Medical University — Zhanjiang
  • Affiliated Cancer Hospital and Institute of Guangzhou Medical University — Guangzhou
  • Huai He Hospital of Henan University — Kaifeng
  • Henan Provincial Chest Hospital — Zhengzhou
  • The First Affiliated Hospital of Xinjiang Medical University — Ürümqi
  • Peking University First Hospital — Beijing
  • Xuanwu Hospital, Capital Medical University — Beijing
  • Hunan Cancer Hospital — Changsha
  • … and 36 more centers

Identifiers

NCT: NCT06862869 · ML45766

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗