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

Roche

Status: Active, not recruiting

Conditions: Carcinoma, Non-Small-Cell Lung

Study type: Observational

Funder types: Industry

Identifiers

NCT05872763

ML44633

Details and patient eligibility

About

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.

Enrollment: 1,200 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

1,200 participants in 2 patient groups

Retrospective cohort (Cohort 1)

Description:

All cases of unresectable stage IIIB/IIIC/IV NSCLC newly diagnosed between January 2020 and the date of the study initiation will be collected. All these participants will be followed up until death or lost-to-follow-up or until 12 months after the last participant is enrolled in cohort 2 in the study.

Prospective cohort (Cohort 2)

Description:

The prospective enrollment of new cases of unresectable stage IIIB/IIIC/IV NSCLC will end up to 1 year after the first patient is enrolled (FPI) in Cohort 2.