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

NCT06617390 | Completed

• 1 other identifier: DS1062-0001-NIS-MA
• Study Type: observational
• Target: 1,041
• Locations: 1 country
• Sites: 6

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.

Conditions

Non-small Cell Lung Cancer (NSCLC)

Keywords

NSCLC; Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Percentage of real-world treatment regimens for second- or third-line therapy in patients with advanced NSCLC

  40 months

Study Arms (2)

AGA Cohort

NSCLC participants with AGA that received second-line or above therapies treatment.

Other: No drug

Non-AGA Cohort

NSCLC participants with non-AGA that received second-line or above therapies treatment.

Other: No drug

Interventions

No drug OTHER

This is a non-interventional study and no study drug will be provided.

AGA Cohort; Non-AGA Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Participants aged ≥18 years when diagnosed with advanced NSCLC.
• Histologically or cytologically confirmed stage IV NSCLC.
• 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.
• 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.

You may not qualify if:

• This study excludes participants who met any of the following criteria.
• Having records of participation or past participation in clinical trial for lung cancer within the data collection period of the study.
• 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.
• 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.

Sponsors & Collaborators

• Daiichi Sankyo: lead

Study Sites (6)

Beijing Cancer Hospital

Beijing, China

Location

The First Affiliated Hospital of Fujian Medical University

Fuzhou, China

Location

Sun Yat-sen University Cancer Center

Guangzhou, China

Location

Affiliated Cancer Hospital of Shandong First Medical University

Jinan, China

Location

Liaoning Cancer Hospital & Institute

Shenyang, China

Location

The First Affiliated Hospital of Soochow University

Suzhou, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2024
• First Posted: September 27, 2024
• Study Start: August 15, 2024
• Primary Completion: January 26, 2025
• Study Completion: July 30, 2025
• Last Updated: August 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (6)