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

Active, not recruiting

• Conditions: Carcinoma, Non-Small-Cell Lung

• Registration Number: NCT05872763
• Lead 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-16
• Study First Submitted QC: 2023-05-16
• Study First Posted: 2023-05-24
• Study Start: 2023-08-11
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-05
• Last Update Posted: 2025-03-07
• Primary Completion: 2026-03-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Median Overall Survival (OS)	Up to 2 years	OS is defined as the time from the date of the first administration of anti-cancer treatment until the date of death from any cause.
Median weeks on first-line treatment	Up to 2 years	First-line treatment will be reported by class of treatment. Median, minimum, and maximum values will be used to summarize the number of weeks on the first line of treatment.

Secondary Outcome Measures

Name	Time	Method
Tumor Molecular Characteristics, measured by the presence of defined biomarkers	Up to 2 years	The defined biomarkers to be identified are EGFR mutations, ALK rearrangement, ROS1 rearrangement, BRAF mutation, neurotrophic tyrosine receptor kinase \[NTRK\] gene fusion, KRAS mutations, and MET mutations. RET rearrangement, ERBB2 (HER2) mutation, and PD-L1 expression.
Anti-cancer Treatment Duration	Up to 2 years
Number of Cycles of Anti-cancer Treatment	Up to 2 years
Number of participants with at least one adverse event, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI-CTCAE v5.0)	Up to 2 years
Treatment Cost to the Participant, measured by accrued fees; pharmacy fee, treatment fee, examinations fee, insurance coverage, and other medical costs	Up to 2 years
Number of Dose Modifications of Anti-Cancer Treatment	Up to 2 years

Trial Locations

Locations (10)

Cancer Hospital Chinese Academy of Medical Sciences.; 🇨🇳 Beijing, China

Beijing Chest Hospital; 🇨🇳 Beijing, China

Sichuan Provincial Cancer Hospital; 🇨🇳 Chengdu, China

Harbin Medical University Cancer Hospital; 🇨🇳 Harbin, China

Shandong Cancer Hospital; 🇨🇳 Jinan, China

Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University); 🇨🇳 Nanjing City, China

Guangxi Cancer Hospital of Guangxi Medical University; 🇨🇳 Nanning, China

Hubei Cancer Hospital; 🇨🇳 Wuhan, China

First Affiliated Hospital of Medical College of Xi'an Jiaotong University; 🇨🇳 Xi'an, China

The First Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, China