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

NCT ID: NCT06496009

Last Updated: 2024-07-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 845 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-07-08
• Study Completion Date: 2027-04-28

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.

Conditions

NSCLC

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

immunotherapy group

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

PD-1 Inhibitors

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

immunotherapy gourp

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Pulmonary Hospital, Shanghai, China

OTHER

Sponsor Role: lead

Responsible Party

Chunxia Su

Director of Clinical Research Center, Shanghai Pulmonary Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chunxia Su, PHD

Role: STUDY_CHAIR

Shanghai Pulmonary Hospital, Shanghai, China

Central Contacts

Li Wang, MD

Role: CONTACT

leewang8023@126.com

18170211997

Other Identifiers

2024LY0532

Identifier Type: -

Identifier Source: org_study_id