Clinical trial NCT05721950: A Study to Learn About Brigatinib Treatment Information Available in Chinese Participants With Non-Small-cell Lung Cancer (NSCLC)
Official title: A Real-World Study to Evaluate the Effectiveness and Safety of Brigatinib in First Line in Patients With ALK Positive Locally Advanced or Metastatic NSCLC in China: An Ambispective, Non-interventional, Observational, Multi-center Study.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Non-small Cell Lung Cancer (NSCLC)
Keywords: Drug Therapy
Real-world Data
Anaplastic Lymphoma Kinase Tyrosine Kinase Inhibitors
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2023-02-10
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Participants diagnosed with ALK positive locally advanced or metastatic NSCLC who received/will receive brigatinib in first line treatment since September 1, 2022 in China.

Brief summary: The main aim of this study is to learn about the time between the start and stop of treatment with brigatinib in Chinese participants with non-small-cell lung cancer (NSCLC) and who have been positively diagnosed with having the anaplastic lymphoma kinase (ALK) gene. Other study aims are to learn about the progression of NSCLC and participants' response to treatment with brigatinib.

Detailed description: This is a non-interventional, ambispective (retrospective + prospective) study of Chinese participants with ALK-positive locally advanced or metastatic NSCLC receiving brigatinib as their first line of treatment from September 1, 2022.This study will evaluate the time-to-treatment discontinuation and other efficacy outcomes of brigatinib in participants with NSCLC in real-world settings.

This study will enroll approximately 200 participants in the following cohort:

• Brigatinib 90 mg/180mg

This study is an ambispective study that will have prospective data collection if participants enrolled after the study initiation or it will have retrospective data collection if the participants have already started receiving brigatinib as first line treatment before study initiation.

This multi-center trial will be conducted in China. Participants will be followed up for safety from signing informed consent until 36 months after the last dose of treatment or until death of the last participant. The overall time for data collection is approximately 8 years.

Eligibility criteria: Inclusion Criteria

1. Age ≥ 18 years.
2. Participant with histologically/cytologically confirmed locally advanced or metastatic NSCLC.
3. Participants with ALK gene rearrangement confirmed by local hospital medical records.
4. Participants who received brigatinib since September 1, 2022 as first line treatment confirmed by medical records.
5. Participants who have at least one medical record after the start of brigatinib treatment.

Exclusion Criteria

1. Participants participated in NSCLC-related interventional clinical trials after locally advanced or metastatic NSCLC diagnosis and during brigatinib treatment.
2. Previously received any other TKIs, including ALK-targeted TKIs.
3. Previously received more than 1 regimen of systemic anticancer therapy for locally advanced or metastatic disease.
4. Participants have been diagnosed as malignancies (excluding completely resected basal cell carcinoma, bladder carcinoma in situ, cervical carcinoma in situ) in addition to NSCLC within the past 5 years.

Primary outcomes:
measure: Real-World Time-to-Treatment Discontinuation (rwTDD)
timeFrame: Up to 8 years
Secondary outcomes:
measure: Real-World Progression-Free Survival (rwPFS)
timeFrame: Up to 8 years
measure: Real-World Progression-Free Survival at Years 1, 2 and 3
timeFrame: Up to 8 years
measure: Real-World Overall Survival (rwOS) at Years 1, 2 and 3
timeFrame: Up to 8 years
measure: Real-World Objective Response Rate (rwORR)
timeFrame: Up to 8 years
measure: Real-World Duration of Response (rwDOR)
timeFrame: Up to 8 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Oncology, Shanghai pulmonary hospital
state: Shanghai
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: