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

Launched by NANFANG HOSPITAL, SOUTHERN MEDICAL UNIVERSITY · Jan 22, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new method called LIRAscore to help predict how well immunotherapy will work for patients with a type of lung cancer known as non-small cell lung cancer (NSCLC). Specifically, the study will involve patients who have locally advanced or metastatic NSCLC, which means the cancer has spread beyond its original site. The goal is to understand if using LIRAscore can help doctors decide the best treatment options, whether it be immunotherapy alone or in combination with chemotherapy. The study aims to enroll 108 participants, and it will track various outcomes such as how well the treatment works and how long patients live after starting treatment.

To be eligible for this study, participants should be adults with confirmed NSCLC that hasn’t been treated before, and they should not have certain genetic changes known as driver gene mutations. Patients must also be willing to provide tissue samples for testing and be in good physical health, as indicated by a specific scoring system. Participants can expect to receive either immunotherapy alone or with chemotherapy and will be monitored closely throughout the study to evaluate their progress and any side effects. Overall, this trial is an important step in finding better ways to treat lung cancer and improve patient outcomes.

Gender

ALL

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 participate in this study;
• • 3. According to the researcher's judgment, the patient is not suitable to participate in this study.