An Observational Study on Predicting the Efficacy of Immunotherapy for NSCLC Based on LIRAscore

Recruiting

• Conditions: Non-small Cell Lung Cancer

• Registration Number: NCT06232265
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief Summary

This is a multi-center, observational clinical study to explore the role of LIRAscore in predicting immunotherapy monotherapy and combination with chemotherapy efficacy and prognosis in locally advanced or metastatic non-small-cell lung cancer. The study plans to enroll 108 patients. The primary endpoint of this study was ORR, and secondary endpoints were PFS, OS, DoR, DCR, and safety.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-22
• Status Verified: 2024-01
• Study First Submitted: 2024-01-22
• Study First Submitted QC: 2024-01-22
• Last Update Submitted: 2024-01-22
• Study First Posted: 2024-01-30
• Last Update Posted: 2024-01-30
• Primary Completion: 2025-08-01
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

1. Patients voluntarily participated in the study, signed the informed consent, and had good compliance;
2. Histologically and/or cytologically confirmed previously untreated, locally advanced or metastatic non-small-cell lung cancer (stage IIIB/IIIC or stage IV) without driver gene mutation;
3. Patients are willing to receive immunotherapy monotherapy or immunotherapy combined with chemotherapy;
4. The patient agrees to provide the remaining tissue samples after clinical routine diagnosis during the baseline period for LIRA score and PD-L1 immunohistochemical testing;
5. The Eastern Organization for Oncology (ECOG) physical fitness score is 0 or 1;
6. The patient has at least one measurable or unmeasurable but evaluable lesion.

Exclusion Criteria

1. According to clinical routine, patients do not meet the criteria for receiving standard anti-tumor treatment;
2. Patients with known EGFR mutations, ALK rearrangements or ROS1 rearrangements are not eligible to participate in this study;
3. According to the researcher's judgment, the patient is not suitable to participate in this study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)	3 years	Defined as the proportion of patients who achieved complete response (CR) or partial response (PR)

Secondary Outcome Measures

Name	Time	Method
Duration of response (DoR)	3 years	Defined as the time from the first recorded objective remission to the disease progression determined by IRC according to RECIST version 1.1, or the time of death from any cause, whichever occurs first.
Disease Control Rate (DCR)	3 years	Defined as the proportion of patients whose best overall efficacy (BOR) determined by IRC according to RECIST 1.1 is complete remission, partial remission, or disease stability
Progression-free Survival (PFS)	3 years	Defined as the time from first recieving treatment to the first occurrence of disease progression or death from any cause determined by IRC based on the Solid Tumor Efficacy Evaluation Criteria (RECIST) 1.1, whichever occurs first
Overall Survival (OS)	3 years	Defined as the time from first treatment to death for any reason.

Trial Locations

Locations (1)

Nanfang Hospital, Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China