Advanced Lung Cancer
Conditions
Brief summary
This is a descriptive observational study in which data are collected in an epidemiological manner. This study is not intended to alter or interfere with the current medical practice of the enrolled patients. Data will be collected in a forward-looking manner. This is a descriptive observational study in which data are collected in an epidemiological manner. This study is not intended to alter or interfere with the current medical practice of the enrolled patients. Data from patients on prior treatment will be collected retrospectively, and data from patients who will be treated later and included in the study will be collected in a prospective manner. The criteria for retrospective collection were consistent with those for prospective collection. Eligible patients will be enrolled after NGS analysis of tumor tissue and informed consent has been obtained. Information required for the study will be collected (every 3 months).
Interventions
No drug intervention or tissue sampling will be included in this study.
Sponsors
Hunan Province Tumor Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients must be ≥18 years of age. 2. Provision of fully informed consent prior to any study specific procedures. 3. Histologically or cytologically confirmed, unresectable stage IIIB/IIIC or stage IV NSCLC. 4. Genetic variants of tumor tissue detected by NGS.
Exclusion criteria
None.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free-Survival | Assessed up to around 4.5 years | From the time the first patient included in the observational analysis received treatment until disease progression, death due to various causes or censored at the date of last contact |
| Overall Survival | Assessed up to around 4.5 years | From the time the first patient included in the observational analysis received treatment until death due to various causes or censored at the date of last contact |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical relevance between genomic profiling and progression-free-survival | Assessed up to around 4.5 years | Kaplan-Meier analysis for progression-free survival, utilizing data from various genetic testing methods including NGS and FISH, to evaluate the impact of different genetic alterations. |
| Clinical relevance between genomic profiling and overall survival | Assessed up to around 4.5 years | Kaplan-Meier analysis for overall survival, utilizing data from various genetic testing methods including NGS and FISH, to evaluate the impact of different genetic alterations. |
| ORR | Assessed up to around 4.5 years | Proportion of patients whose tumor volume shrinks to a pre-specified value (usually 30%) and who are able to maintain the minimum timeframe requirements. |
Countries
China
Contacts
Primary ContactYongchang Zhang, MD
Backup ContactNong Yang
Outcome results
None listed