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

NCT ID: NCT06617390

Last Updated: 2025-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1041 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-15

Study Completion Date

2025-07-30

Brief Summary

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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

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Conditions

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Non-small Cell Lung Cancer (NSCLC)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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AGA Cohort

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

No drug

Intervention Type OTHER

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

Non-AGA Cohort

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

No drug

Intervention Type OTHER

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

Interventions

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No drug

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Daiichi Sankyo

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Beijing Cancer Hospital

Beijing, , China

Site Status

The First Affiliated Hospital of Fujian Medical University

Fuzhou, , China

Site Status

Sun Yat-sen University Cancer Center

Guangzhou, , China

Site Status

Affiliated Cancer Hospital of Shandong First Medical University

Jinan, , China

Site Status

Liaoning Cancer Hospital & Institute

Shenyang, , China

Site Status

The First Affiliated Hospital of Soochow University

Suzhou, , China

Site Status

Countries

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China

Other Identifiers

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DS1062-0001-NIS-MA

Identifier Type: -

Identifier Source: org_study_id

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