Non-small Cell Lung CancerNCT06586801
The Patient-Reported Outcomes in ALK Positive Advanced NSCLC in China
An observational study of Non-small Cell Lung Cancer, run by Shanghai East Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Patient-reported outcome
- How many people
- 800 participants
- Where
- No sites listed yet
- Study dates
- 20 Sep 2024to 30 Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Multicenter Prospective Cohort Study of the Patient-Reported Outcomes in ALK Positive Advanced Non-Small Cell Lung Cancer (NSCLC) in China
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.
Read the 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
- Being tested
- Patient-reported outcome
- Keywords
- ALK+ NSCLC
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient-reported outcomeOther
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)
| Study group | Role | What they receive |
|---|---|---|
| Cohort I | 400 ALK-positive locally advanced or metastatic NSCLC patients who are treated with Alectinib Receives: Other: Patient-reported outcome | |
| Cohort II | 200 ALK-positive locally advanced or metastatic NSCLC patients who are treated with Lorlatinib Receives: 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 Receives: Other: Patient-reported outcome |
What is being measured
The primary outcome is the main question the study is designed to answer.
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) .
Measured: 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).
Measured: 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.
Measured: 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)
Measured: 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
Incidence and severity of adverse events, based on the NCI CTCAE v5.0.
Measured: 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
ALK-TKIs treatment changes (dose modifications and/or discontinuation of treatment) and the rationale for treatment changes.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start20 Sep 2024 (estimated)
- Primary completion10 May 2025 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai East Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Zhejiang Cancer Hospital, Henan Cancer Hospital
- Responsible party
- Sponsor
- Investigators
- Caicun Zhou, Principal investigator, Shanghai East Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06586801
- Sponsor's protocol ID
- ML44840
- Status last verified
- Sep 2024
- First submitted
- 24 Aug 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Prospective Cohort Study of the Patient-Reported Outcomes in ALK Positive Advanced Non-Small Cell Lung Cancer (NSCLC) in China
- ClinicalTrials.gov ID
- NCT06586801
- Acronym / sponsor ID
- ML44840
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- ALK+ NSCLC
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Shanghai East HospitalUniversity, hospital or other
- Collaborators
- Zhejiang Cancer Hospital, Henan Cancer Hospital
- Study start
- 20 Sep 2024 (estimated)
- Primary completion
- 10 May 2025 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort I | – | Other: Patient-reported outcome400 ALK-positive locally advanced or metastatic NSCLC patients who are treated with Alectinib |
| Cohort II | – | Other: Patient-reported outcome200 ALK-positive locally advanced or metastatic NSCLC patients who are treated with Lorlatinib |
| Cohort III | – | Other: Patient-reported outcome200 ALK-positive locally advanced or metastatic NSCLC patients who are treated with other ALK-TKIs except for Alectinib and Lorlatinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient-reported outcomePatient-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) | Other | Cohort I, Cohort II, Cohort III |
Primary outcome
EORTC QLQ-LC13
Time frame: 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.
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) .
EORTC QLQ-C30
Time frame: 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.
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).
NCI PRO-CTCAE
Time frame: 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.
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.
EORTC Item List (IL46)
Time frame: 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.
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)
2 secondary outcomes
To evaluate the safety of ALK-TKIs as first-line treatment in advanced ALK+ NSCLC
Time frame: 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
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
Related trials for Non-small Cell Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caicun Zhou principal investigator
Shanghai East Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Non-small Cell Lung Cancer, run by Shanghai East Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fei Zhou (13801751704, story185@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EORTC QLQ-LC13 (time frame: 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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024; AzTrials last refreshed its copy on 7 Nov 2026.