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

NCT05872763 | Active Not Recruiting

• 1 other identifier: ML44633
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 12

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.

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (6)

• Tumor Molecular Characteristics, measured by the presence of defined biomarkers

  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 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

• Anti-cancer Treatment Duration

  Up to 2 years

• Number of Cycles of Anti-cancer Treatment

  Up to 2 years

Study Arms (2)

Retrospective cohort (Cohort 1)

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)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will be conducted at multiple sites that will be selected from a pool of hospitals in China from 7 geographic regions (Northwest, Northeast, North, Southwest, South, Central, East) across China. And a target number of 7-10 sites across these regions were planned to be involved to ensure a relatively even number of patients to be enrolled from each region.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (12)

Cancer Hospital Chinese Academy of Medical Sciences.

Beijing, 100021, China

Location

Beijing Chest Hospital

Beijing, 101149, China

Location

Sichuan Provincial Cancer Hospital

Chengdu, 610041, China

Location

Harbin Medical University Cancer Hospital

Harbin, 150081, China

Location

Shandong Cancer Hospital

Jinan, 250117, China

Location

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

Nanjing, 210029, China

Location

Guangxi Cancer Hospital of Guangxi Medical University

Nanning, 530021, China

Location

The Fourth Hospital of Hebei Medical University

Shijiazhuang, 050000, China

Location

Shanxi Province Cancer Hospital

Taiyuan, 030013, China

Location

Hubei Cancer Hospital

Wuhan, 430079, China

Location

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

Xi'an, 710061, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, 450052, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2023
• First Posted: May 24, 2023
• Study Start: August 11, 2023
• Primary Completion (Estimated): November 6, 2026
• Study Completion (Estimated): November 6, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (12)