To hear about similar clinical trials, please enter your email below
Trial Title:
A Study of Participants in China With Non-Small-Cell Lung Cancer That is Unable to be Treated With Surgery
NCT ID:
NCT05872763
Condition:
Carcinoma, Non-Small-Cell Lung
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Conditions: Keywords:
Non-Small Cell Lung Cancer
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Other
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Cancer Hospital Chinese Academy of Medical Sciences.
Address:
City:
Beijing
Zip:
100021
Country:
China
Status:
Recruiting
Facility:
Name:
Beijing Chest Hospital; Oncology Department
Address:
City:
Beijing
Zip:
101149
Country:
China
Status:
Recruiting
Facility:
Name:
Sichuan Provincial Cancer Hospital
Address:
City:
Chengdu
Zip:
610041
Country:
China
Status:
Recruiting
Facility:
Name:
Harbin Medical University Cancer Hospital
Address:
City:
Harbin
Zip:
150081
Country:
China
Status:
Recruiting
Facility:
Name:
Shandong Cancer Hospital
Address:
City:
Jinan
Zip:
250117
Country:
China
Status:
Recruiting
Facility:
Name:
Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
Address:
City:
Nanjing City
Zip:
210029
Country:
China
Status:
Recruiting
Facility:
Name:
Guangxi Cancer Hospital of Guangxi Medical University
Address:
City:
Nanning City
Zip:
530021
Country:
China
Status:
Recruiting
Facility:
Name:
First Affiliated Hospital of Medical College of Xi'an Jiaotong University
Address:
City:
Xi'an
Zip:
710061
Country:
China
Status:
Recruiting
Facility:
Name:
The First Affiliated Hospital of Zhengzhou University
Address:
City:
Zhengzhou
Zip:
450052
Country:
China
Status:
Recruiting
Start date:
August 11, 2023
Completion date:
June 30, 2025
Lead sponsor:
Agency:
Hoffmann-La Roche
Agency class:
Industry
Source:
Hoffmann-La Roche
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05872763
