Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06586801
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-24
Brief Title:
The Patient-Reported Outcomes in ALK Positive Advanced NSCLC in China
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Multicenter Prospective Cohort Study of the Patient-Reported Outcomes in ALK Positive Advanced Non-Small Cell Lung Cancer NSCLC in China
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 questionnairePatients 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
Changes 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 andor 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 scores
Secondary analysis Incidence and severity of adverse events based on the NCI CTCAE v50 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 94 SAS Institute Inc Cary North Carolina
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 questionnairePatients 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
Changes 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 andor 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 scores
Secondary analysis Incidence and severity of adverse events based on the NCI CTCAE v50 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 94 SAS Institute Inc Cary North Carolina
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None