Clinical trial NCT05872763: A Study of Participants in China With Non-Small-Cell Lung Cancer That is Unable to be Treated With Surgery
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: Non-Small Cell Lung Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2023-05-24
Enrollment: 1200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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.


Eligibility 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

Primary outcomes:
measure: Median Overall Survival (OS)
timeFrame: Up to 2 years
measure: Median weeks on first-line treatment
timeFrame: Up to 2 years
Secondary outcomes:
measure: Tumor Molecular Characteristics, measured by the presence of defined biomarkers
timeFrame: Up to 2 years
measure: Treatment Cost to the Participant, measured by accrued fees; pharmacy fee, treatment fee, examinations fee, insurance coverage, and other medical costs
timeFrame: Up to 2 years
measure: 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)
timeFrame: Up to 2 years
measure: Anti-cancer Treatment Duration
timeFrame: Up to 2 years
measure: Number of Cycles of Anti-cancer Treatment
timeFrame: Up to 2 years
measure: Number of Dose Modifications of Anti-Cancer Treatment
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences.
city: Beijing
country: China
facility: Beijing Chest Hospital
city: Chengdu
country: China
facility: Sichuan Provincial Cancer Hospital
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
city: Jinan
country: China
facility: Shandong Cancer Hospital
city: Nanjing City
country: China
facility: Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
city: Nanning
country: China
facility: Guangxi Cancer Hospital of Guangxi Medical University
city: Shijiazhuang
country: China
facility: The Fourth Hospital of Hebei Medical University
city: Taiyuan City
country: China
facility: Shanxi Province Cancer Hospital
city: Wuhan
country: China
facility: Hubei Cancer Hospital
city: Xi'an
country: China
facility: First Affiliated Hospital of Medical College of Xi'an Jiaotong University
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: