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

Last updated: July 4, 2025
Sponsor: Hoffmann-La Roche
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT05872763
ML44633
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 wererequired to have two complete tumor assessments within at least 6 months intervalsafter the diagnosis

  • Participants who were newly diagnosed within six months before the start of thestudy were required to have complete baseline information (see section 6.4.1)

  • Participants who have received standard first-line treatment defined by guidelineCSCO (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 NSCLCafter 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 targetingunresectable stage IIIB/IIIC/IV NSCLC in the study site after study initiation

Exclusion

Exclusion Criteria:

  • Participants who have received prior systematic treatment for unresectable StageIIIB/IIIC/IV NSCLC

  • Participants who have participated in any anti-cancer, regimen-specified clinicalstudy of first-line treatment for unresectable Stage IIIB/IIIC/IV NSCLC

Study Design

Total Participants: 1200
Study Start date:
August 11, 2023
Estimated Completion Date:
February 21, 2026

Connect with a study center

  • Beijing Chest Hospital

    Beijing, 101149
    China

    Site Not Available

  • Beijing Chest Hospital; Oncology Department

    Beijing, 101149
    China

    Active - Recruiting

  • Cancer Hospital Chinese Academy of Medical Sciences.

    Beijing, 100021
    China

    Site Not Available

  • Sichuan Provincial Cancer Hospital

    Chengdu, 610041
    China

    Site Not Available

  • Harbin Medical University Cancer Hospital

    Harbin, 150081
    China

    Site Not Available

  • Shandong Cancer Hospital

    Jinan, 250117
    China

    Site Not Available

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

    Nanjing City, 210029
    China

    Site Not Available

  • Guangxi Cancer Hospital of Guangxi Medical University

    Nanning, 530021
    China

    Site Not Available

  • Guangxi Cancer Hospital of Guangxi Medical University

    Nanning City, 530021
    China

    Site Not Available

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, 050000
    China

    Site Not Available

  • Shanxi Province Cancer Hospital

    Taiyuan City, 030013
    China

    Site Not Available

  • Hubei Cancer Hospital

    Wuhan, 430079
    China

    Site Not Available

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

    Xi'an, 710061
    China

    Site Not Available

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, 450052
    China

    Site Not Available

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