An Observational Study to Evaluate the Real-World Clinical Management and Outcomes of ALK-Positive Advanced NSCLC Participants Treated With Alectinib
- Registration Number
- NCT04764188
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This study aims to characterize the clinical management and outcomes of participants diagnosed with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) who are being treated with alectinib in real-world clinical practice.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 800
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cohort 1 Alectinib Participants starting alectinib treatment after (Arm A) or before (Arm B) study enrollment as first-line treatment will be followed up for up to 4 years. Cohort 2 Alectinib Participants receiving alectinib as second-line treatment after study enrollment will be followed up for up to 2 years.
- Primary Outcome Measures
Name Time Method Investigator-Confirmed Progression-Free Survival (PFS) According to the Local Standard of Care or per Response Evaluation in Solid Tumors (RECIST) - Cohort 1 From the first administration of alectinib to the date of first documentation of disease progression, or death due to any cause, whichever occurs first (up to 4 years) Reasons for Discontinuation of Next LoT Up to approximately 1 year Investigator-Confirmed PFS According to the Local Standard of Care or per RECIST - Cohort 2 From the first administration of alectinib to the date of first documentation of disease progression, or death due to any cause, whichever occurs first (up to 2 years) Duration of Next LoT Up to approximately 1 year Choice of the Next Line of Treatment (LoT) Post-Alectinib Up to approximately 1 year
- Secondary Outcome Measures
Name Time Method Time to Loss of Clinical Benefit (TTLCB) From the first administration of alectinib to loss of clinical benefit as assessed by the treating physician (up to 4 years for Cohort 1 and 2 years for Cohort 2) Duration of Objective Response (DOR) From first documentation of CR or PR (whichever occurs first) after the first administration of alectinib until death or progressive disease (PD) (up to 4 years for Cohort 1 and 2 years for Cohort 2) Time to Response From the first administration of alectinib to first CR or PR (up to 4 years for Cohort 1 and 2 years for Cohort 2) Overall Survival (OS) From the first administration of alectinib to death from any cause (up to 4 years for Cohort 1 and 2 years for Cohort 2) Objective Response Rate (ORR), Defined as a Complete Response (CR) or Partial Response (PR) From the first administration of alectinib to first CR or PR (up to 4 years for Cohort 1 and Cohort 2) Duration of Disease Control Time from the first administration of alectinib to the first documentation of CR, PR, or stable disease (whichever occurs first), until death or PD (up to 4 years for Cohort 1 and 2 years for Cohort 2) Time to Central Nervous System (CNS) Progression (Cohort 1 Arm A) Time interval from the first administration of alectinib to the date of confirmed CNS metastases in participants with no CNS metastases at baseline (up to 4 years) Disease Control Rate (DCR) At least 12 weeks after the first administration of alectinib (up to 4 years for Cohort 1 and 2 years for Cohort 2) Time to Initiation of Next Line of Treatment (LoT) From the first administration of alectinib to the date of initiation of next LoT or death due to any cause, whichever occurs first (up to 4 years for Cohort 1 and 2 years for Cohort 2) Quality of Life Status Using the EORTC QLQ-LC13 Scores (Cohort 1 Arm A and Cohort 2) At enrollment and every 3 months thereafter (up to 4 years for Cohort 1 and 2 years for Cohort 2) Quality of Life Status Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Scores At enrollment and every 3 months thereafter (up to 4 years for Cohort 1 and 2 years for Cohort 2)
Trial Locations
- Locations (116)
Clinica Adventista Belgrano
🇦🇷Ciudad Autonoma Buenos Aires, Argentina
Lifehouse
🇦🇺Camperdown, New South Wales, Australia
Liverpool Hospital
🇦🇺Liverpool, New South Wales, Australia
GenesisCare North Shore
🇦🇺St Leonards, New South Wales, Australia
Royal North Shore Hospital
🇦🇺St. Leonards, New South Wales, Australia
Flinders Medical Centre
🇦🇺Bedford Park, South Australia, Australia
Peter MacCallum Cancer Center
🇦🇺East Melbourne, Victoria, Australia
Klinikum Klagenfurt am Wörtersee
🇦🇹Klagenfurt am Worthersee, Austria
Klinik Penzing
🇦🇹Wien, Austria
Krankenhaus Nord - Klinik Floridsdorf
🇦🇹Wien, Austria
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