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

NCT ID: NCT06586801

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 800 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-09-20
• Study Completion Date: 2026-09-30

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.

Detailed Description

A total of 800 patients with ALK+ NSCLC will be enrolled in this study. The actual number of sites can be increased or decreased as appropriate. In order to approach the real world medication situation, the number of patients treated with Alectinib will be 400 cases; the number of patients treated with Lorlatinib will be 200 cases; the number of patients treated with the other ALK-TKIs will be 200 cases in total.

Study Population The study population is intended to follow the real-world use of ALK-TKIs treatment; therefore, minimal inclusion and exclusion criteria will be used. The study population will comprise patients treated with ALK-TKIs for ALK-positive advanced NSCLC.

Patients in all 3 cohorts who meet any of the following criteria will be excluded from study entry:

• 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 Statistical Methods Primary Analysis The primary objective for this study is to describe the patient-reported outcomes in patients with ALK+ locally advanced or metastatic NSCLC who received ALK-TKIs as first-line treatment in the real world situation. Analyses were conducted using the full analysis set (FAS), which comprised all 3 cohorts of patients enrolled in the study population with at least baseline data in eCRFs. The PRO analysis set consists of all patients in the FAS who completed at least one baseline questionnaire and at least one post baseline questionnaire.Patients with no post-baseline information will be censored at the date of enrollment.

Proportion of patients reporting clinically meaningful deterioration (decrease from baseline of ≥ 10 points) in the subscales of EORTC QLQ-LC13 (fatigue, chest pain) and QLQ-C30 (cognitive, physical and role functioning) will be summarized.

Change(s) from baseline scores will be conducted for fatigue, chest pain as measured by the EORTC QLQ-LC13 and cognitive functioning, physical and role functioning by QLQ-C30 at each assessment time point.

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 Frequency of patients' response of the degree they are troubled with treatment symptoms, as assessed through use of the single-item EORTC Item List (IL46) Summary statistics (number of patients, mean, standard deviation, median, minimum, maximum, 95% CI) will be applied for baseline characteristics and absolute score(s).

Secondary analysis Incidence and severity of adverse events based on the NCI CTCAE v5.0 and the rate of ALK-TKIs treatment changes by different reasons will be summarized to evaluate the safety and tolerability of ALK-TKIs as first-line treatment in each three cohorts. All variables will be summarized by number of patients, mean, standard deviation, median, minimum, maximum.

Analyses were conducted using SAS statistical software, version 9.4 (SAS Institute Inc, Cary, North Carolina).

Conditions

Non-small Cell Lung Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Cohort I

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

Patient-reported outcome

Intervention Type: 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 II

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

Patient-reported outcome

Intervention Type: 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 III

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

Patient-reported outcome

Intervention Type: 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)

Interventions

Patient-reported outcome

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)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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
• Patients with advanced NSCLC who have asymptomatic central nervous system (CNS) metastases are eligible for inclusion

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang Cancer Hospital

OTHER

Sponsor Role: collaborator

Henan Cancer Hospital

OTHER_GOV

Sponsor Role: collaborator

Shanghai East Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Caicun Zhou

Role: PRINCIPAL_INVESTIGATOR

Shanghai East Hospital

Central Contacts

Fei Zhou

Role: CONTACT

story185@126.com

13801751704

Other Identifiers

ML44840

Identifier Type: -

Identifier Source: org_study_id