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

Nanfang Hospital, Southern Medical University

Status: Enrolling

Conditions: Non-small Cell Lung Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT06232265

NFEC-2023-412

Details and patient eligibility

About

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.

Enrollment: 108 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.