Active — Not RecruitingNot Applicable

An Observational Study to Evaluate the Real-World Clinical Management and Outcomes of ALK-Positive Advanced NSCLC Participants Treated With Alectinib

Argentina, Australia, Austria800 participantsStarted 2021-05-10

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Investigator-Confirmed Progression-Free Survival (PFS) According to the Local Standard of Care or per Response Evaluation in Solid Tumors (RECIST) - Cohort 1

Timeframe: 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

Timeframe: 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

Timeframe: Up to approximately 1 year

Duration of Next LoT

Timeframe: Up to approximately 1 year

Reasons for Discontinuation of Next LoT

Timeframe: Up to approximately 1 year

Trial details

NCT IDNCT04764188

SponsorHoffmann-La Roche

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2027-05-10

View on ClinicalTrials.gov More NSCLC trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Investigator-Confirmed Progression-Free Survival (PFS) According to the Local Standard of Care or per Response Evaluation in Solid Tumors (RECIST) - Cohort 1

Timeframe: 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

Timeframe: 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

Timeframe: Up to approximately 1 year

Duration of Next LoT

Timeframe: Up to approximately 1 year

Reasons for Discontinuation of Next LoT

Timeframe: Up to approximately 1 year