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

NCT06496009 | Not Yet Recruiting

• 1 other identifier: 2024LY0532
• Study Type: observational
• Target: 845
• Locations: 0 countries
• Sites: N/A

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.

Conditions

NSCLC

Keywords

NSCLC; PD-L1 negative; immunotherapy

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 12 month

Secondary Outcomes (3)

• Progression-Free Survival

  up to 24 months

• Overall Survival

  up to 36 months

• Objective Response Rate

  up to 9 month

Study Arms (1)

immunotherapy group

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

Drug: PD-1 Inhibitors

Interventions

PD-1 Inhibitors DRUG

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

Also known as: immunotherapy gourp

immunotherapy group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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).

You may not qualify if:

• The patient refused to join this study and declined follow-up.

Sponsors & Collaborators

• Shanghai Pulmonary Hospital, Shanghai, China: lead

MeSH Terms

Interventions

Immune Checkpoint Inhibitors

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses

Study Officials

• Chunxia Su, PHD

  Shanghai Pulmonary Hospital, Shanghai, China

  STUDY CHAIR

Central Study Contacts

Li Wang, MD

CONTACT

18170211997; leewang8023@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Clinical Research Center, Shanghai Pulmonary Hospital

Study Record Dates

• First Submitted: July 3, 2024
• First Posted: July 11, 2024
• Study Start: July 8, 2024
• Primary Completion: April 28, 2026
• Study Completion (Estimated): April 28, 2027
• Last Updated: July 11, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: up to 36 month
• Access Criteria: Send an email requesting research