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NCT05872763 | Recruiting | Carcinoma, Non-Small-Cell Lung

A Study of Participants in China With Non-Small-Cell Lung Cancer That is Unable to be Treated With Surgery
Sponsor:

Hoffmann-La Roche

Brief Summary:

This is a multicenter, observational cohort study in China with both primary prospective data collection and retrospective collection of prior treatment information from medical records, which enrolls and follows patients who are newly diagnosed with unresectable stage IIIB/IIIC/IV Non-Small-Cell Lung Cancer (NSCLC) in the selected sites. This study aims to describe the clinical practice and long-term survival benefits of patients newly diagnosed with unresectable stage IIIB/IIIC/IV NSCLC. The study also seeks to explore the condition of biomarker tests utilization, and to assess potential economic impact on patients in the real world. The safety related events will also be summarized in this study.

Condition or disease

Carcinoma, Non-Small-Cell Lung

Study Type : Observational
Estimated Enrollment : 1200 participants
Official Title : An Observational Cohort Study of Patients With Newly Diagnosed Unresectable Stage IIIB, IIIC, or IV Non-Small-Cell Lung Cancer (NSCLC) in China
Actual Study Start Date : August 11, 2023
Estimated Primary Completion Date : June 30, 2025
Estimated Study Completion Date : June 30, 2025

Information not available for Arms and Intervention/treatment

Ages Eligible for Study:
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • Cohort 1
    • Participants who have diagnosed with unresectable stage IIIB/IIIC/IV NSCLC
    • Participants who have been diagnosed six months before the start of the study were required to have two complete tumor assessments within at least 6 months intervals after the diagnosis
    • Participants who were newly diagnosed within six months before the start of the study were required to have complete baseline information (see section 6.4.1)
    • Participants who have received standard first-line treatment defined by guideline CSCO (https://www.csco.org.cn/cn/index.aspx) and NCCN (https://www.nccn.org/)
    • Cohort 2
      • Participants who are newly diagnosed with unresectable Stage IIIB/IIIC/IV NSCLC after the start of the study
      • Participants who are able to be followed up by the participating site
      • Participants planned to receive first line anti-cancer treatment targeting unresectable stage IIIB/IIIC/IV NSCLC in the study site after study initiation
      Exclusion Criteria
      • Participants who have received prior systematic treatment for unresectable Stage IIIB/IIIC/IV NSCLC
      • Participants who have participated in any anti-cancer, regimen-specified clinical study of first-line treatment for unresectable Stage IIIB/IIIC/IV NSCLC
A Study of Participants in China With Non-Small-Cell Lung Cancer That is Unable to be Treated With Surgery

Location Details

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A Study of Participants in China With Non-Small-Cell Lung Cancer That is Unable to be Treated With Surgery

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Recruiting

China,

Cancer Hospital Chinese Academy of Medical Sciences.

Beijing, China, 100021

Recruiting

China,

Sichuan Provincial Cancer Hospital

Chengdu, China, 610041

Recruiting

China,

Harbin Medical University Cancer Hospital

Harbin, China, 150081

Recruiting

China,

Shandong Cancer Hospital

women, China, 250117

Recruiting

China,

Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)

Nanjing City, China, 210029

Recruiting

China,

Guangxi Cancer Hospital of Guangxi Medical University

Nanning City, China, 530021

Recruiting

China,

First Affiliated Hospital of Medical College of Xi'an Jiaotong University

Xi'an, China, 710061

Recruiting

China,

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, China, 450052