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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

108 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-22

Study Completion Date

2026-08-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Non-small Cell Lung Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No