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

Non-small Cell Lung Cancer Clinical Trial

Official title:

An Observational Study on Predicting the Efficacy of Immunotherapy for Non-small-cell Lung Cancer Based on LIRAscore

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06232265
• Other study ID #: NFEC-2023-412
• Status: Recruiting
• Start date: September 22, 2023
• Est. completion date: August 1, 2026

Study information

• Verified date: January 2024
• Source: Nanfang Hospital, Southern Medical University
• Contact: Wangjun Liao, MD, PhD
• Phone: 86-20-62787731
• Email: nfyyliaowj[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: August 1, 2026
• Est. primary completion date: August 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Locations

Country	Name	City	State
China	Nanfang Hospital, Southern Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital, Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate (ORR)	Defined as the proportion of patients who achieved complete response (CR) or partial response (PR)	3 years
Secondary	Progression-free Survival (PFS)	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	3 years
Secondary	Overall Survival (OS)	Defined as the time from first treatment to death for any reason.	3 years
Secondary	Duration of response (DoR)	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.	3 years
Secondary	Disease Control Rate (DCR)	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	3 years