Clinical trial NCT05863819: A Real World Study of Mobocertinib in Adults With Lung Cancer in China (MEANING)
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
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Non-small Cell Lung Cancer (NSCLC)
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2023-05-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with EGFR ex20ins positive locally advanced or metastatic NSCLC who have received mobocertinib in China's routine clinical practice setting.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Real-World Time-to-Treatment Discontinuation (rwTTD)
timeFrame: Up to 18 months
Secondary outcomes:
measure: Real-World Overall Response Rate (rwORR)
timeFrame: Up to 18 months
measure: Real-World Duration of Response (rwDOR)
timeFrame: Up to 18 months
measure: Real-World Disease Control Rate (rwDCR)
timeFrame: Up to 18 months
measure: Median Real-World Progression-Free Survival (rwPFS)
timeFrame: Up to 18 months
measure: Real-World PFS (rwPFS) Rate at 1-year, 1.5-year and 2-year
timeFrame: Up to 2 years
measure: Real-World Overall Survival (rwOS) Rate at 1-year, 1.5-year and 2-year
timeFrame: Up to 2 years
measure: 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
timeFrame: Up to 18 months
measure: TTD Based on Cough per EORTC Quality of Life Questionnaire Lung Cancer module (QLQ-LC13) Scale
timeFrame: Up to 18 months
measure: TTD Based on Dyspnea per EORTC QLQ-LC13 Scale
timeFrame: Up to 18 months
measure: TTD Based on Chest Pain Scores per EORTC QLQ-LC13 Scale
timeFrame: Up to 18 months
measure: Number of Participants Categorized with Demographic Characteristics at Baseline
timeFrame: At Baseline (Day 1)
measure: Number of Participants Categorized with Clinicopathological Characteristics at Baseline
timeFrame: At Baseline (Day 1)
measure: Number of Participants Categorized with Co-Mutation Characteristics at Baseline
timeFrame: At Baseline (Day 1) at the timing of mobocertinib initiation date
measure: Number of Participants with Adverse Events (AEs) Related to Mobocertinib
timeFrame: Up to 18 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiaotong University, P. R. China
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: