The Clinical Characteristics and Efficacy of Immunotherapy in First-line PD-L1-negative Advanced NSCLC Patients

N/ANot Yet RecruitingNCT06496009

Shanghai Pulmonary Hospital, Shanghai, China845 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

845

Conditions

NSCLC

Interventions

PD-1 InhibitorsDRUG

advanced or metastatic non-small cell lung cancer who are PD-L1 negative and receiving first-line immunotherapy in routine clinical practice

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

1-year Progression-Free Survival (PFS) rate

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.

Time frame: up to 12 month

Secondary Outcomes

Progression-Free Survival

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.

Time frame: up to 24 months

Overall Survival

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

Time frame: up to 36 months

Objective Response Rate

Objective Response Rate (ORR) refers to the proportion of patients whose cancer shrinks (partial response) or disappears (complete response) after treatment.

Time frame: up to 9 month

Central Contacts

Li Wang, MD

CONTACT

18170211997 leewang8023@126.com

Data from ClinicalTrials.gov

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