NSCLC
Conditions
Keywords
NSCLC, PD-L1 negative, immunotherapy
Brief summary
This study aims to include patients with advanced or metastatic non-small cell lung cancer who are PD-L1 negative and receiving first-line immunotherapy in routine clinical practice.
Detailed description
This study aims to include patients with advanced or metastatic non-small cell lung cancer who are PD-L1 negative and receiving first-line immunotherapy in routine clinical practice. Clinical treatment of patients will not be intervened unless disease progression, intolerable toxicity, initiation of new anti-tumor therapy, withdrawal of informed consent, loss to follow-up, death, or other circumstances deemed appropriate by the investigator to discontinue treatment, whichever occurs first. The primary objective of the study is for investigators to assess the one-year progression-free survival (PFS) rate of immunotherapy as first-line treatment in PD-L1 negative advanced or metastatic NSCLC, evaluated according to RECIST 1.1 criteria.
Interventions
DRUGPD-1 Inhibitors
advanced or metastatic non-small cell lung cancer who are PD-L1 negative and receiving first-line immunotherapy in routine clinical practice
Sponsors
Shanghai Pulmonary Hospital, Shanghai, China
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Written informed consent must be obtained before implementing any trial-related procedures; * Aged 18-80 years; * Wild-type EGFR/ALK; * Patients with locally advanced (stage IIIb/IIIc), metastatic, or recurrent (stage IV) NSCLC confirmed by histology or cytology, who are not eligible for curative surgery and cannot undergo definitive radiotherapy/chemotherapy, according to the 8th edition of the TNM staging classification by the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer; * PD-L1 negative； * Patients receiving first-line immunotherapy (such as PD-1/PD-L1 inhibitors).
Exclusion criteria
* The patient refused to join this study and declined follow-up.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1-year Progression-Free Survival (PFS) rate | up to 12 month | The 1-year Progression-Free Survival (PFS) rate is a clinical metric used to measure the percentage of patients who are still alive and have not experienced disease progression one year after the start of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival | up to 24 months | PFS is the length of time during and after treatment that a patient lives with the disease but it does not get worse. It is a standard measure used in clinical trials to evaluate the effectiveness of a treatment. |
| Overall Survival | up to 36 months | OS refers to the length of time from either the date of diagnosis or the start of treatment that patients diagnosed with a disease are still alive |
| Objective Response Rate | up to 9 month | Objective Response Rate (ORR) refers to the proportion of patients whose cancer shrinks (partial response) or disappears (complete response) after treatment. |
Contacts
Primary ContactLi Wang, MD
Outcome results
None listed