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

An Observational Cohort Study of Patients With Newly Diagnosed Unresectable Stage IIIB, IIIC, or IV Non-Small-Cell Lung Cancer (NSCLC) in China

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.

Study Overview

• Status: Recruiting
• Conditions: Carcinoma, Non-Small-Cell Lung

• Study Type: Observational
• Enrollment (Estimated): 1200

Contacts and Locations

• Study Contact: Name: Reference Study ID Number: ML44633 https://forpatients.roche.com/; Phone Number: 888-662-6728; Email: global-roche-genentech-trials@gene.com

Study Locations

• China
  • Beijing, China, 100021
    • Recruiting
    • Cancer Hospital Chinese Academy of Medical Sciences.
  • Chengdu, China, 610041
    • Recruiting
    • Sichuan Provincial Cancer Hospital
  • Harbin, China, 150081
    • Recruiting
    • Harbin Medical University Cancer Hospital
  • Jinan, China, 250117
    • Recruiting
    • Shandong Cancer Hospital
  • Nanjing City, China, 210029
    • Recruiting
    • Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
  • Nanning City, China, 530021
    • Recruiting
    • Guangxi Cancer Hospital of Guangxi Medical University
  • Xi'an, China, 710061
    • Recruiting
    • First Affiliated Hospital of Medical College of Xi'an Jiaotong University
  • Zhengzhou, China, 450052
    • Recruiting
    • the First Affiliated Hospital of Zhengzhou University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Number of Dose Modifications of Anti-Cancer Treatment		Up to 2 years

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): August 11, 2023
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: May 16, 2023
• First Submitted That Met QC Criteria: May 16, 2023
• First Posted (Actual): May 24, 2023

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Non-Small Cell Lung Cancer
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: ML44633

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).

For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/innovation/process/clinical-trials/data-sharing/).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No