An observational study in NSCLC, sponsored by Hoffmann-La Roche. Active, not recruiting at 116 sites in 25 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-10.
Sponsored by Hoffmann-La Roche · Observational
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.
Eligible participants will be identified in real-world clinical settings.
Exclusion Criteria
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.
Drug: Alectinib
Participants receiving alectinib as second-line treatment after study enrollment will be followed up for up to 2 years.
Drug: Alectinib
Participants will receive alectinib in accordance with local clinical practice and local labeling.
Investigator-Confirmed Progression-Free Survival (PFS) According to the Local Standard of Care or per Response Evaluation in Solid Tumors (RECIST) - Cohort 1
Time frame: 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
Time frame: 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
Time frame: Up to approximately 1 year
Duration of Next LoT
Time frame: Up to approximately 1 year
Reasons for Discontinuation of Next LoT
Time frame: Up to approximately 1 year
Time to Loss of Clinical Benefit (TTLCB)
Time frame: 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)
Time frame: 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)
Time frame: From the first administration of alectinib to first CR or PR (up to 4 years for Cohort 1 and Cohort 2)
Time to Response
Time frame: 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)
Time frame: 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)
Time frame: 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 frame: 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 frame: 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)
Time frame: 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
Time frame: 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)
Time frame: At enrollment and every 3 months thereafter (up to 4 years for Cohort 1 and 2 years for Cohort 2)
Showing the first 100 of 116 sites across 25 countries.
Plan to share: Yes — For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Hoffmann-La Roche