A Real World Study of Mobocertinib in Adults With Lung Cancer in China (MEANING) (MEANING-20)

Takeda

Status: Withdrawn

Conditions: Non-small Cell Lung Cancer (NSCLC)

Treatments: Other: No Intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT05863819

TAK-788-4005

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Participants with histologically/cytologically confirmed diagnosis of EGFR ex20ins positive locally advanced or metastatic NSCLC by local hospitals.
2. 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.
3. The decision to treat a participant with mobocertinib had to be made independently by physician before enrollment into the study.

Exclusion criteria

1. Participants who are participating in other NSCLC interventional clinical study during the treatment of mobocertinib in this study will be excluded;
2. Other situations that the investigators consider not suitable for participation in this study.

Trial design

0 participants in 1 patient group

Mobocertinib

Description:

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.

Treatment:

Other: No Intervention