A Study of Real-world Treatment Patterns and Outcomes in Chinese Advanced NSCLC Patients Who Previously Received at Least 2 Line Treatments

Active, not recruiting

• Conditions: Non-small Cell Lung Cancer (NSCLC)
• Interventions: Other: No drug

• Registration Number: NCT06617390
• Lead Sponsor: Daiichi Sankyo

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-15
• Study First Submitted: 2024-09-25
• Study First Submitted QC: 2024-09-25
• Study First Posted: 2024-09-27
• Primary Completion: 2025-01-26
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-15
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
AGA Cohort	No drug	NSCLC participants with AGA that received second-line or above therapies treatment.
Non-AGA Cohort	No drug	NSCLC participants with non-AGA that received second-line or above therapies treatment.

Primary Outcome Measures

Name	Time	Method
Percentage of real-world treatment regimens for second- or third-line therapy in patients with advanced NSCLC	40 months

Trial Locations

Locations (6)

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, China

The First Affiliated Hospital of Fujian Medical University; 🇨🇳 Fuzhou, China

Beijing Cancer Hospital; 🇨🇳 Beijing, China

Affiliated Cancer Hospital of Shandong First Medical University; 🇨🇳 Jinan, China

Liaoning Cancer Hospital & Institute; 🇨🇳 Shenyang, China

The First Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, China