Clinical trial NCT06862869: Real World Clinical Outcomes of Resected ALK-Positive Early Stage NSCLC Patients Treated With Alectinib as Adjuvant Therapy
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Carcinoma, Non-Small-Cell Lung
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2025-03-06
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants in China with resected stage II-IIIB ALK-positive NSCLC treated with adjuvant Alectinib according to standard of care.

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.


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

Primary outcomes:
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:
measure: Duration of alectinib therapy
timeFrame: From start of treatment to the date of treatment discontinuation (up to approximately 2.5 years)
measure: Participant demographics by disease stage and city tier
timeFrame: Up to approximately 2.5 years
measure: Participant clinical characteristics as determined by Eastern Cooperative Oncology Group performance status (ECOG PS) by disease stage and city tier
timeFrame: Up to approximately 2.5 years
measure: Participant clinical characteristics as determined by surgery history by disease stage and city tier
timeFrame: Up to approximately 2.5 years
measure: Emotional and physical functioning as determined by the 36-item short form survey (SF-36) v2 questionnaires
timeFrame: At enrollment, then every approximately 3 months thereafter (up to approximately 2.5 years)
measure: Incidence and severity of adverse events (AEs)
timeFrame: Baseline to withdrawal from study or 28 days after the last dose of alectinib, whichever occurs first
Other outcomes:
Locations:
city: Lanzhou
country: China
facility: Lanzhou University Second Hospital
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
city: Wuxi
country: China
facility: Wuxi People's Hospital
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: