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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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 |
| 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 |
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Inclusion Criteria:
Cohort 1:
Cohort 2:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital Chinese Academy of Medical Sciences. | Beijing | 100021 | China | |||
| Beijing Chest Hospital |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| 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 |
| Beijing |
| 101149 |
| China |
| Sichuan Provincial Cancer Hospital | Chengdu | 610041 | China |
| Harbin Medical University Cancer Hospital | Harbin | 150081 | China |
| Shandong Cancer Hospital | Jinan | 250117 | China |
| Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University) | Nanjing | 210029 | China |
| Guangxi Cancer Hospital of Guangxi Medical University | Nanning | 530021 | China |
| The Fourth Hospital of Hebei Medical University | Shijiazhuang | 050000 | China |
| Shanxi Province Cancer Hospital | Taiyuan | 030013 | China |
| Hubei Cancer Hospital | Wuhan | 430079 | China |
| First Affiliated Hospital of Medical College of Xi'an Jiaotong University | Xi'an | 710061 | China |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | 450052 | China |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |