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

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ClinicalTrials.gov Identifier: NCT04764188
Recruitment Status : Recruiting
First Posted : February 21, 2021
Last Update Posted : March 7, 2022
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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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.

Condition or disease Intervention/treatment
NSCLC Drug: Alectinib

Study Design
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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official 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)
Actual Study Start Date : May 10, 2021
Estimated Primary Completion Date : April 9, 2027
Estimated Study Completion Date : April 9, 2027

Resource links provided by the National Library of Medicine

Drug Information available for: Alectinib

Groups and Cohorts
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Group/Cohort Intervention/treatment
Cohort 1
Participants starting alectinib treatment before (Arm A) or after (Arm B) study enrollment as first-line treatment will be followed up for up to 4 years.
 Drug: Alectinib
Participants will receive alectinib in accordance with local clinical practice and local labeling.
Cohort 2
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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Eligible participants will be identified in real-world clinical settings.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04764188


Contacts
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Contact: Reference Study ID Number: MO42122 https://forpatients.roche.com/ 888-662-6728 global-roche-genentech-trials@gene.com

Locations
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Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-LaRoche
More Information
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT04764188    
Other Study ID Numbers: MO42122
First Posted: February 21, 2021    Key Record Dates
Last Update Posted: March 7, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
Keywords provided by Hoffmann-La Roche:
ALK-positive NSCLC
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
 Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases