NCT05863819

A Real World Study of Mobocertinib in Adults With Lung Cancer in China (MEANING)

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

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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)

Interventions

Type	Name	Description
OTHER	No Intervention	As this is an observational study, no intervention will be administered in this study.

Timeline

• Start date: 2024-03-30
• Primary completion: 2026-12-01
• Completion: 2027-02-01
• First posted: 2023-05-18
• Last updated: 2023-10-18

Locations

1 site across 1 country: China