NSCLC
Conditions
Keywords
ALK-positive NSCLC
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.
Interventions
DRUGAlectinib
Participants will receive alectinib in accordance with local clinical practice and local labeling.
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Confirmed diagnosis of advanced NSCLC (stage IIIB, IIIC, IVA, or IVB) on or after the date of local approval for alectinib as first-line treatment and/or second-line treatment 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 confirmed by immunohistochemistry (IHC), fluorescent in situ hybridization (FISH), next generation sequencing (NGS), or other non-specified sequencing methods, documented prior to receiving treatment with an ALK inhibitor * Cohort 1: Currently receiving, or planned to receive, treatment for ALK-positive advanced NSCLC with alectinib as first-line treatment * Cohort 2: Planned to receive treatment for ALK-positive advanced NSCLC with alectinib as second-line treatment * Able to be followed-up by participating site * Participants with advanced NSCLC who have CNS metastases are eligible for inclusion
Exclusion criteria
* Participants not receiving alectinib for the treatment of ALK-positive advanced NSCLC according to standard of care and in line with local product information * Participants not receiving the Roche studied medicinal product * Participants who have received or are currently receiving alectinib as an investigational study drug in a clinical trial for the treatment of advanced NSCLC
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) |
| 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) |
| Choice of the Next Line of Treatment (LoT) Post-Alectinib | Up to approximately 1 year |
| Duration of Next LoT | Up to approximately 1 year |
| Reasons for Discontinuation of Next LoT | Up to approximately 1 year |
Secondary
| Measure | Time frame |
|---|---|
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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 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) |
| 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) |
Countries
Argentina, Australia, Austria, Belgium, Bulgaria, Chile, China, Colombia, Croatia, Cuba, Czechia, Finland, Israel, Italy, Lithuania, Panama, Peru, Portugal, Romania, Russia, Serbia, Turkey (Türkiye), United Arab Emirates, Uruguay, Vietnam
Contacts
STUDY_DIRECTORClinical Trials
Hoffmann-LaRoche
Outcome results
None listed