Study Stopped
Business reason, unrelated to product safety
A Real World Study of Mobocertinib in Adults With Lung Cancer in China (MEANING)
MEANING-20
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
1 other identifier
observational
N/A
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Mar 2024
Typical duration for all trials
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 9, 2023
CompletedFirst Posted
Study publicly available on registry
May 18, 2023
CompletedStudy Start
First participant enrolled
March 30, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2027
October 18, 2023
October 1, 2023
2.7 years
May 9, 2023
October 16, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Up to 18 months
Secondary Outcomes (14)
Real-World Overall Response Rate (rwORR)
Up to 18 months
Real-World Duration of Response (rwDOR)
Up to 18 months
Real-World Disease Control Rate (rwDCR)
Up to 18 months
Median Real-World Progression-Free Survival (rwPFS)
Up to 18 months
Real-World PFS (rwPFS) Rate at 1-year, 1.5-year and 2-year
Up to 2 years
- +9 more secondary outcomes
Study Arms (1)
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.
Interventions
As this is an observational study, no intervention will be administered in this study.
Eligibility Criteria
Participants with EGFR ex20ins positive locally advanced or metastatic NSCLC who have received mobocertinib in China's routine clinical practice setting.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (1)
Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiaotong University, P. R. China
Shanghai, 200032, China
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 9, 2023
First Posted
May 18, 2023
Study Start
March 30, 2024
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
February 1, 2027
Last Updated
October 18, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Access Criteria
- IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
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.