Non-small Cell Lung Cancer (NSCLC)MEANING-20NCT05863819
A Real World Study of Mobocertinib in Adults With Lung Cancer in China (MEANING)
An observational study of Non-small Cell Lung Cancer (NSCLC), run by Takeda at 1 site in China.
Trial summary
The main aim of this study is to learn about the time from start of mobocertinib to end of treatment with mobocertinib for any reason in Chinese adults with lung cancer who carry a certain gene mutation (epidermial growth factor receptor - EGFR exon 20 insertion mutation) during normal clinical practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer (NSCLC)
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 30 Mar 2024to 1 Feb 2027
- 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: Participants with EGFR ex20ins positive locally advanced or metastatic NSCLC who have received mobocertinib in China's routine clinical practice setting.
Who may be able to join
- Participants with histologically/cytologically confirmed diagnosis of EGFR ex20ins positive locally advanced or metastatic NSCLC by local hospitals.
- Participants who received mobocertinib as treatment therapy in routine clinical practice; the decision to treat with mobocertinib had to be made independently by physician before enrollment into the study.
- The decision to treat a participant with mobocertinib had to be made independently by physician before enrollment into the study.
Who cannot join
- Participants who are participating in other NSCLC interventional clinical study during the treatment of mobocertinib in this study will be excluded;
- Other situations that the investigators consider not suitable for participation in this study.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiaotong University, P. R. China
Shanghai, 200032
About this study
Official title: Effectiveness and Safety of Mobocertinib in Patients With EGFR Exon 20 Insertion NSCLC in Routine Clinical Practice in China: A Prospective, Single-arm, Multicenter, Observational Study
The main aim of this study is to learn about the time from start of mobocertinib to end of treatment with mobocertinib for any reason in Chinese adults with lung cancer who carry a certain gene mutation (epidermial growth factor receptor - EGFR exon 20 insertion mutation) during normal clinical practice.
Participants will be treated with mobocertinib as per their normal routine. Data for this study will be collected from the available medical records of a participant.
Read the detailed description
This is a non-interventional, prospective, observational study of participants with EGFR ex20ins positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who received mobocertinib in China's routine clinical practice setting. The primary objective of this study is to assess the real-world time-to-treatment discontinuation (rwTTD) of mobocertinib in study participants.
The study will enroll approximately 120 participants. Participants will be enrolled in the following cohort:
- Mobocertinib
Participants will be treated with mobocertinib as per their normal routine treatment. Data for this study will be collected from the available medical records of a participant every 3 months until the end of treatment and follow up (up to 18 months).
This multi-center trial will be conducted in China. The overall duration of the study will be approximately 3 years.
- Conditions
- Non-small Cell Lung Cancer (NSCLC)
- Being tested
- No Intervention
- Keywords
- Drug Therapy
- 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.
No InterventionOther
As this is an observational study, no intervention will be administered in this study.
| Study group | Role | What they receive |
|---|---|---|
| Mobocertinib | Participants with EGFR ex20ins positive locally advanced or metastatic NSCLC who have received mobocertinib in China's routine clinical practice setting will be observed in this study. The observation period for each participant is planned to be 18 months, starting from the participant who received mobocertinib enrolled in this study and ending at the earliest occurrence of the completion of 18 months of follow-up, death, loss to follow-up, or withdrawal from the study. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Real-World Time-to-Treatment Discontinuation (rwTTD)
Real-world time-to-treatment discontinuation (rwTTD) is defined as the time from initiation of mobocertinib to discontinuation of treatment with mobocertinib for any reason, including disease progression, death, serious adverse events, or participant preference.
Measured: Up to 18 months
Secondary outcomes (14)
Real-World Overall Response Rate (rwORR)
rwORR is defined as the percentage of participants who are confirmed to achieved complete response (CR) or partial response (PR) after receiving mobocertinib in a real word setting. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. CR is defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm.
Measured: Up to 18 months
Real-World Duration of Response (rwDOR)
rwDOR is defined as the time from the measurement criteria are first met for CR/PR (whichever is first recorded) for participants who have achieved confirmed objective response rate (ORR) after receiving mobocertinib to progression or death in a real word setting.
Measured: Up to 18 months
Real-World Disease Control Rate (rwDCR)
rwDCR is defined as the percentage of participants who are confirmed to achieved CR or partial response PR or stable disease (SD) after receiving mobocertinib in a real word setting.PR: partial reduction in size of visible disease in some, or all, areas without any increase in visible disease. SD: no change in overall size of visible disease, or mixed response (some lesions increased, some lesions decreased).
Measured: Up to 18 months
Median Real-World Progression-Free Survival (rwPFS)
rwPFS is defined as the time from initiation of mobocertinib to disease progression or death from any cause, or the time of the last confirmed survival in real world setting.
Measured: Up to 18 months
Real-World PFS (rwPFS) Rate at 1-year, 1.5-year and 2-year
rwPFS rate at 1-year, 1.5-year and 2-years are defined as the probability of progression free survival over one year from initiation of mobocertinib and the probability of progression-free survival over 1.5 years from initiation of mobocertinib. If data is available, the probability of progression-free survival over 2 years from initiation of mobocertinib will also be calculated.
Measured: Up to 2 years
Real-World Overall Survival (rwOS) Rate at 1-year, 1.5-year and 2-year
rwOS rate at 1-year, 1.5-year, and 2-year are defined as the probability of overall survival over one year from initiation of mobocertinib and the probability of overall survival over 1.5 years from initiation of mobocertinib. If data is available, the probability of overall survival over 2 years from initiation of mobocertinib will also be calculated.
Measured: Up to 2 years
Time to Deterioration (TTD) Based on Physical Functioning per European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) (v3.0) Scale
TTD is defined as the time from baseline to the occurrence of first clinical meaningful deterioration compared to baseline score of EORTC QLQ-C30. TTD will be assessed using QLQ-30 physical function scale using the Kaplan-Meier Method.
Measured: Up to 18 months
TTD Based on Cough per EORTC Quality of Life Questionnaire Lung Cancer module (QLQ-LC13) Scale
TTD is defined as the time from baseline to the occurrence of first clinical meaningful deterioration compared to baseline score of EORTC QLQ-LC13. TTD will be assessed using QLQ-LC13 cough scale using the Kaplan-Meier Method.
Measured: Up to 18 months
TTD Based on Dyspnea per EORTC QLQ-LC13 Scale
TTD is defined as the time from baseline to the occurrence of first clinical meaningful deterioration compared to baseline score of EORTC QLQ-LC13. TTD will be assessed using QLQ-LC13 dyspnea scale using the Kaplan-Meier Method.
Measured: Up to 18 months
TTD Based on Chest Pain Scores per EORTC QLQ-LC13 Scale
TTD is defined as the time from baseline to the occurrence of first clinical meaningful deterioration compared to baseline score of EORTC QLQ-LC13. TTD will be assessed using QLQ-LC13 chest pain scores using the Kaplan-Meier Method.
Measured: Up to 18 months
Number of Participants Categorized with Demographic Characteristics at Baseline
Demographic characteristics will include age, gender, smoking history, smoking status and family history for malignancies.
Measured: At Baseline (Day 1)
Number of Participants Categorized with Clinicopathological Characteristics at Baseline
Clinicopathological characteristics will include Eastern Cooperative Oncology Group Performance Status (ECOG PS); medical history including clinically significant disease, surgeries, cancer history; current status of lung cancer; comorbidity; Histology: adenocarcinoma, squamous cell carcinoma, mixed, or others; EGFR mutation testing; and co-mutation status.
Measured: At Baseline (Day 1)
Number of Participants Categorized with Co-Mutation Characteristics at Baseline
Co-Mutation characteristics will include gene mutation testing methods and results in participants.
Measured: At Baseline (Day 1) at the timing of mobocertinib initiation date
Number of Participants with Adverse Events (AEs) Related to Mobocertinib
AEs refer to any reasons leading to the dose modification, interruption or discontinuation of mobocertinib in Chinese participants with EGFR ex20ins positive locally advanced or metastatic NSCLC in real world setting. Data will be collected from the participant's medical records.
Measured: Up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start30 Mar 2024 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Why it stopped: Business reason, unrelated to product safety
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 Cancer (NSCLC)Studies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05863819
- Sponsor's protocol ID
- TAK-788-4005
- Acronym
- MEANING-20
- Status last verified
- Oct 2023
- First submitted
- 9 May 2023
- Last updated
- 18 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Mobocertinib in Patients With EGFR Exon 20 Insertion NSCLC in Routine Clinical Practice in China: A Prospective, Single-arm, Multicenter, Observational Study
- ClinicalTrials.gov ID
- NCT05863819
- Acronym / sponsor ID
- MEANING-20 / TAK-788-4005
- Conditions
- Non-small Cell Lung Cancer (NSCLC)
- Keywords
- Drug Therapy
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Business reason, unrelated to product safety
- Enrolment
- 0 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 30 Mar 2024 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 18 May 2023 (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.
The main aim of this study is to learn about the time from start of mobocertinib to end of treatment with mobocertinib for any reason in Chinese adults with lung cancer who carry a certain gene mutation (epidermial growth factor receptor - EGFR exon 20 insertion mutation) during normal clinical practice.
Participants will be treated with mobocertinib as per their normal routine. Data for this study will be collected from the available medical records of a participant.
Detailed description
This is a non-interventional, prospective, observational study of participants with EGFR ex20ins positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who received mobocertinib in China's routine clinical practice setting. The primary objective of this study is to assess the real-world time-to-treatment discontinuation (rwTTD) of mobocertinib in study participants.
The study will enroll approximately 120 participants. Participants will be enrolled in the following cohort:
- Mobocertinib
Participants will be treated with mobocertinib as per their normal routine treatment. Data for this study will be collected from the available medical records of a participant every 3 months until the end of treatment and follow up (up to 18 months).
This multi-center trial will be conducted in China. The overall duration of the study will be approximately 3 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mobocertinib | – | Other: No InterventionParticipants with EGFR ex20ins positive locally advanced or metastatic NSCLC who have received mobocertinib in China's routine clinical practice setting will be observed in this study. The observation period for each participant is planned to be 18 months, starting from the participant who received mobocertinib enrolled in this study and ending at the earliest occurrence of the completion of 18 months of follow-up, death, loss to follow-up, or withdrawal from the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with EGFR ex20ins positive locally advanced or metastatic NSCLC who have received mobocertinib in China's routine clinical practice setting.
Key inclusion criteria (3 listed)
- Participants with histologically/cytologically confirmed diagnosis of EGFR ex20ins positive locally advanced or metastatic NSCLC by local hospitals.
- Participants who received mobocertinib as treatment therapy in routine clinical practice; the decision to treat with mobocertinib had to be made independently by physician before enrollment into the study.
- The decision to treat a participant with mobocertinib had to be made independently by physician before enrollment into the study.
Key exclusion criteria (2 listed)
- Participants who are participating in other NSCLC interventional clinical study during the treatment of mobocertinib in this study will be excluded;
- Other situations that the investigators consider not suitable for participation in this study.
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 |
|---|---|---|
| No InterventionAs this is an observational study, no intervention will be administered in this study. | Other | Mobocertinib |
Primary outcome
Real-World Time-to-Treatment Discontinuation (rwTTD)
Time frame: Up to 18 months
Real-world time-to-treatment discontinuation (rwTTD) is defined as the time from initiation of mobocertinib to discontinuation of treatment with mobocertinib for any reason, including disease progression, death, serious adverse events, or participant preference.
14 secondary outcomes
Real-World Overall Response Rate (rwORR)
Time frame: Up to 18 months
Real-World Duration of Response (rwDOR)
Time frame: Up to 18 months
Real-World Disease Control Rate (rwDCR)
Time frame: Up to 18 months
Median Real-World Progression-Free Survival (rwPFS)
Time frame: Up to 18 months
Real-World PFS (rwPFS) Rate at 1-year, 1.5-year and 2-year
Time frame: Up to 2 years
Real-World Overall Survival (rwOS) Rate at 1-year, 1.5-year and 2-year
Time frame: Up to 2 years
Time to Deterioration (TTD) Based on Physical Functioning per European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) (v3.0) Scale
Time frame: Up to 18 months
TTD Based on Cough per EORTC Quality of Life Questionnaire Lung Cancer module (QLQ-LC13) Scale
Time frame: Up to 18 months
TTD Based on Dyspnea per EORTC QLQ-LC13 Scale
Time frame: Up to 18 months
TTD Based on Chest Pain Scores per EORTC QLQ-LC13 Scale
Time frame: Up to 18 months
Number of Participants Categorized with Demographic Characteristics at Baseline
Time frame: At Baseline (Day 1)
Number of Participants Categorized with Clinicopathological Characteristics at Baseline
Time frame: At Baseline (Day 1)
Number of Participants Categorized with Co-Mutation Characteristics at Baseline
Time frame: At Baseline (Day 1) at the timing of mobocertinib initiation date
Number of Participants with Adverse Events (AEs) Related to Mobocertinib
Time frame: Up to 18 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
- To obtain more information on the study, click here/on this linkLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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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.
Study Director study director
Takeda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-small Cell Lung Cancer (NSCLC), run by Takeda at 1 site in China.
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 3 inclusion and 2 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: withdrawn, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Real-World Time-to-Treatment Discontinuation (rwTTD) (time frame: Up to 18 months). 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 18 Oct 2023.