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

Carcinoma, Non-Small-Cell Lung Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05872763
• Other study ID #: ML44633
• Status: Recruiting
• Start date: August 11, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: June 2024
• Source: Hoffmann-La Roche
• Contact: Reference Study ID Number: ML44633 https://forpatients.roche.com
• Phone: 888-662-6728
• Email: global-roche-genentech-trials[@]gene.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms

Locations

Country	Name	City	State
China	Cancer Hospital Chinese Academy of Medical Sciences.	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 City
China	First Affiliated Hospital of Medical College of Xi'an Jiaotong University	Xi'an
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median Overall Survival (OS)	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.	Up to 2 years
Primary	Median weeks on first-line treatment	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.	Up to 2 years
Secondary	Tumor Molecular Characteristics, measured by the presence of defined biomarkers	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.	Up to 2 years
Secondary	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
Secondary	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
Secondary	Anti-cancer Treatment Duration		Up to 2 years
Secondary	Number of Cycles of Anti-cancer Treatment		Up to 2 years
Secondary	Number of Dose Modifications of Anti-Cancer Treatment		Up to 2 years