Status:
NOT_YET_RECRUITING
The Patient-Reported Outcomes in ALK Positive Advanced NSCLC in China
Lead Sponsor:
Shanghai East Hospital
Collaborating Sponsors:
Zhejiang Cancer Hospital
Henan Cancer Hospital
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Brief Summary
This is a multicenter, prospective, longitudinal observational study designed to evaluate the patient-reported outcomes and safety profiles of patients with ALK positive advanced Non-Small Cell Lung C...
Detailed Description
A total of 800 patients with ALK+ NSCLC will be enrolled in this study. The actual number of sites can be increased or decreased as appropriate. In order to approach the real world medication situatio...
Eligibility Criteria
Inclusion
- Have signed the informed consent form (ICF) as per local regulations
- Female or male aged 18 years or older
- Ability to comply with the study protocol, in the judgment of the investigator
- Life expectancy ≥ 12 weeks
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0, 1, or 2
- Have a confirmed diagnosis of locally advanced or metastatic NSCLC on or after the date of local approval for ALK-TKIs as first-line monotherapy regimen for ALK-positive advanced NSCLC and planned to receive treatment as per routine for at least one cycle (28 days) while on study
- ALK positive as determined by Ventana immunohistochemistry (IHC), fluorescent in situ hybridization (FISH), reverse transcription polymerase chain reaction(RT-PCR) and next generation sequencing (NGS), documented prior to receiving treatment with an ALK inhibitor
- Planned to receive, treatment for ALK-positive advanced NSCLC with ALK-TKIs
- Able to be followed up at the participating site
- Patients with advanced NSCLC who have asymptomatic central nervous system (CNS) metastases are eligible for inclusion
Exclusion
- Patients receiving ALK-TKIs as investigational study drugs in a clinical trial for the treatment of advanced NSCLC
- Patients participating in clinical trials within 28 days prior to initiation of study treatment
- Pregnant, lactating, or breastfeeding women
Key Trial Info
Start Date :
September 20 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2026
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT06586801
Start Date
September 20 2024
End Date
September 30 2026
Last Update
September 19 2024
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