Clinical trial NCT06617390: A Study of Real-world Treatment Patterns and Outcomes in Chinese Advanced NSCLC Patients Who Previously Received at Least 2 Line Treatments
Official title: Real-world Treatment Patterns and Outcomes in Chinese Advanced NSCLC Patients Who Previously Received at Least 2 Line Treatment: a Multi-center, Non-interventional and Retrospective Real-world Study (RECAP)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Non-small Cell Lung Cancer (NSCLC)
Keywords: NSCLC
Lung Cancer
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2024-09-27
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with advanced NSCLC who have received at least 2L treatment between September 1, 2019, and December 31, 2022.

Brief summary: This study will retrospectively collect data of patients with advanced non-small cell lung cancer who have received at least 2 line treatment to investigate treatment patterns, relevant outcomes, and biomarkers detection patterns in Chinese patients with Actionable Genomic Alterations (AGA) or non-AGA.


Eligibility criteria: Inclusion Criteria:

1. Participants aged ≥18 years when diagnosed with advanced NSCLC.
2. Histologically or cytologically confirmed stage IV NSCLC.
3. For non-AGA participants , second- or third-line systemic treatment occurred between September 1, 2019 and December 31, 2022, and participants received corresponding immunotherapy in the first or second line.
4. For AGA participants , second- or third-line systemic treatment occurred between September 1, 2019 and December 31, 2022. Among them, participants with documented positive result for EGFR, ALK, or ROS1 testing received corresponding targeted therapy in the first or second line.

Exclusion Criteria:

This study excludes participants who met any of the following criteria.

1. Having records of participation or past participation in clinical trial for lung cancer within the data collection period of the study.
2. Participants with a concomitant cancer at the time of diagnosis of NSCLC (except for non-metastatic non-melanoma skin cancers, in situ or benign neoplasms). Occurrence of cancer within 5 years after NSCLC diagnosis will be considered as secondary cancer.
3. Histology of the tumor is small cell lung cancer, neuroendocrine in origin, or a mixed histologic type with small cell and non-small cell lung cancers.
4. Participants with significantly missing medical record data or patients deemed inappropriate for inclusion by investigators.

Primary outcomes:
measure: Percentage of real-world treatment regimens for second- or third-line therapy in patients with advanced NSCLC
timeFrame: 40 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
city: Jinan
country: China
facility: Affiliated Cancer Hospital of Shandong First Medical University
city: Shenyang
country: China
facility: Liaoning Cancer Hospital & Institute
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
Study officials:
References: