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NCT Number: NCT04764188

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

NSCLC

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinica Adventista Belgrano, Ciudad Autonoma Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alectinib

Drug

Participants will receive alectinib in accordance with local clinical practice and local labeling.

Primary outcomes

  1. 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)

  2. 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)

  3. Choice of the Next Line of Treatment (LoT) Post-Alectinib

    Time frame: Up to approximately 1 year

  4. Duration of Next LoT

    Time frame: Up to approximately 1 year

  5. Reasons for Discontinuation of Next LoT

    Time frame: Up to approximately 1 year

Secondary outcomes

  1. 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)

  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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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)

  10. 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)

  11. 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)

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Multicenter Non-Interventional Cohort Study to Evaluate the Real-World Clinical Management and Outcomes of Patients Diagnosed With ALK-Positive Advanced NSCLC Treated With Alectinib (ReAlec)

Acronym: ReAlec

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Feb 21, 2021
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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