The Patient-Reported Outcomes in ALK Positive Advanced NSCLC in China

NCT06586801 | Not Yet Recruiting

• 1 other identifier: ML44840
• Study Type: observational
• Target: 800
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a multicenter, prospective, longitudinal observational study designed to evaluate the patient-reported outcomes and safety profiles of patients with ALK positive advanced Non-Small Cell Lung Cancer (NSCLC) who received ALK-TKIs as first-line treatment. Approximately 800 patients with ALK-positive locally advanced or metastatic NSCLC will be enrolled in this study. This study has 3 parallel cohorts which are listed below. Patient-reported outcome data will be collected using the following instruments: EORTC QLQ-C30, EORTC QLQ-LC13, selected items from the PRO-CTCAE, EORTC-IL46.

Conditions

Non-small Cell Lung Cancer

Keywords

ALK+ NSCLC

Outcome Measures

Primary Outcomes (4)

• EORTC QLQ-LC13

  Proportion of patients reporting clinically meaningful deterioration (decrease from baseline of ≥10 points) in the subscales of EORTC QLQ-LC13 (fatigue, chest pain) ;Change from baseline score (by 2 cycles) in the subscales of EORTC QLQ-LC13 (fatigue, chest pain) .

  The data collection period for an individual patient was approximately 12 months, which could be truncated by treatment switching, patient withdrawal from the study, or death.

• EORTC QLQ-C30

  Proportion of patients reporting clinically meaningful deterioration (decrease from baseline of ≥ 10 points) in the subscales of QLQ-C30 (cognitive, physical and role functioning);Change from baseline score (by 2 cycles) in the subscales of QLQ-C30 (cognitive, physical and role functioning).

  The data collection period for an individual patient was approximately 12 months, which could be truncated by treatment switching, patient withdrawal from the study, or death.

• NCI PRO-CTCAE

  Presence, frequency of occurrence, severity, and/or degree of interference with daily function of symptomatic treatment toxicities (swelling, rash, blurred vision, anxious, sad) as assessed through use of the NCI PRO-CTCAE.

  The data collection period for an individual patient was approximately 12 months, which could be truncated by treatment switching, patient withdrawal from the study, or death.

• EORTC Item List (IL46)

  Frequency of patients\' response of the degree they are troubled with treatment symptoms, as assessed through use of the Protocol ML44840, Version 2.0 single-item EORTC Item List (IL46)

  The data collection period for an individual patient was approximately 12 months, which could be truncated by treatment switching, patient withdrawal from the study, or death.

Secondary Outcomes (2)

• To evaluate the safety of ALK-TKIs as first-line treatment in advanced ALK+ NSCLC

  The data collection period for an individual patient was approximately 12 months, which could be truncated by treatment switching, patient withdrawal from the study, or death.

• To evaluate the tolerability of ALK-TKIs as first-line treatment in advanced ALK+ NSCLC

  The data collection period for an individual patient was approximately 12 months, which could be truncated by treatment switching, patient withdrawal from the study, or death.

Study Arms (3)

Cohort I

400 ALK-positive locally advanced or metastatic NSCLC patients who are treated with Alectinib

Other: Patient-reported outcome

Cohort II

200 ALK-positive locally advanced or metastatic NSCLC patients who are treated with Lorlatinib

Other: Patient-reported outcome

Cohort III

200 ALK-positive locally advanced or metastatic NSCLC patients who are treated with other ALK-TKIs except for Alectinib and Lorlatinib

Other: Patient-reported outcome

Interventions

Patient-reported outcome OTHER

Patient-reported outcome data will be collected using the following instruments:EORTC QLQ-C30, EORTC QLQ-LC13, selected items from the PRO-CTCAE, EORTC-IL46. The first collection of the information in questionnaires (EORTC QLQ-C30, EORTC QLQ-LC13, PRO-CTCAE \[select items\]), which defined as baseline- PROs, will be completed at Cycle 1, Day 1±7days prior to administration of study drug; then the rest times of collection will be completed at every two treatment cycle prior to administration of study drug (i.e., on Cycle 3, Day 1±7days; Cycle 5, Day 1±7days; Cycle 7, Day 1±7days; Cycle 9, Day 1±7days; Cycle 11, Day 1±7days; Cycle 13, Day 1±7days) . EORTC-IL46 will be completed at Cycle 3, Day 1±7days (baseline) prior to administration of study drug; then at every other study treatment cycle prior to administration of study drug (i.e., on Cycle 5, Day 1±7days; Cycle 7, Day 1±7days; Cycle 9, Day 1±7days; Cycle 11, Day 1±7days; Cycle 13, Day 1±7days)

Cohort I; Cohort II; Cohort III

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population comprises patients with ALK-positive advanced NSCLC who are treated with ALK-TKIs according to standard of care and in line with local product information.

You may qualify if:

• Have signed the informed consent form (ICF) as per local regulations
• Female or male aged 18 years or older
• Ability to comply with the study protocol, in the judgment of the investigator
• Life expectancy ≥ 12 weeks
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0, 1, or 2
• Have a confirmed diagnosis of locally advanced or metastatic NSCLC on or after the date of local approval for ALK-TKIs as first-line monotherapy regimen 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 determined by Ventana immunohistochemistry (IHC), fluorescent in situ hybridization (FISH), reverse transcription polymerase chain reaction(RT-PCR) and next generation sequencing (NGS), documented prior to receiving treatment with an ALK inhibitor
• Planned to receive, treatment for ALK-positive advanced NSCLC with ALK-TKIs
• Able to be followed up at the participating site

You may not qualify if:

• Patients receiving ALK-TKIs as investigational study drugs in a clinical trial for the treatment of advanced NSCLC
• Patients participating in clinical trials within 28 days prior to initiation of study treatment
• Pregnant, lactating, or breastfeeding women

Sponsors & Collaborators

• Shanghai East Hospital: lead
• Zhejiang Cancer Hospital: collaborator
• Henan Cancer Hospital: collaborator

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Patient Reported Outcome Measures

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Health Care Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Services Research; Health Planning; Health Care Economics and Organizations; Patient Outcome Assessment; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health

Study Officials

• Caicun Zhou

  Shanghai East Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fei Zhou

CONTACT

13801751704; story185@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2024
• First Posted: September 19, 2024
• Study Start: September 20, 2024
• Primary Completion: May 10, 2025
• Study Completion (Estimated): September 30, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share