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

Not yet recruiting

• Conditions: NSCLC
• Interventions: Drug: PD-1 Inhibitors

• Registration Number: NCT06496009
• Lead Sponsor: Shanghai Pulmonary Hospital, Shanghai, China

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.

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-03
• Study First Submitted QC: 2024-07-03
• Last Update Submitted: 2024-07-03
• Study Start: 2024-07-08
• Study First Posted: 2024-07-11
• Last Update Posted: 2024-07-11
• Primary Completion: 2026-04-28
• Study Completion: 2027-04-28

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 845

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
immunotherapy group	PD-1 Inhibitors	advanced or metastatic non-small cell lung cancer who are PD-L1 negative and receiving first-line immunotherapy in routine clinical practice

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.