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Recruiting NCT06232265

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

Trial Parameters

Condition Non-small Cell Lung Cancer
Sponsor Nanfang Hospital, Southern Medical University
Study Type OBSERVATIONAL
Phase N/A
Enrollment 108
Sex ALL
Min Age N/A
Max Age N/A
Start Date 2023-09-22
Completion 2025-08-01

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.

Eligibility Criteria

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 partici

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