Observing how LIRAscore predicts immunotherapy success in lung cancer
An Observational Study on Predicting the Efficacy of Immunotherapy for Non-small-cell Lung Cancer Based on LIRAscore
This study is testing if the LIRAscore can help predict how well immunotherapy works for people with advanced lung cancer who haven't had treatment before.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 108 (estimated) |
| Sex | All |
| Sponsor | Nanfang Hospital, Southern Medical University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06232265 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the effectiveness of the LIRAscore in predicting the outcomes of immunotherapy, both alone and in combination with chemotherapy, for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). The study will enroll 108 patients who have not received prior treatment and will assess various endpoints including overall response rate (ORR), progression-free survival (PFS), overall survival (OS), duration of response (DoR), disease control rate (DCR), and safety. Participants will provide tissue samples for LIRA score and PD-L1 testing to facilitate this analysis.
Who should consider this trial
Good fit: Ideal candidates include patients with untreated, locally advanced or metastatic NSCLC who do not have specific driver gene mutations and are willing to undergo immunotherapy.
Not a fit: Patients with known EGFR mutations, ALK rearrangements, or ROS1 rearrangements may not benefit from this study as they are excluded from participation.
Why it matters
Potential benefit: If successful, this study could help identify which patients are most likely to benefit from immunotherapy, leading to more personalized and effective treatment strategies.
How similar studies have performed: While the use of biomarkers like LIRAscore in predicting treatment efficacy is a growing area of interest, this specific approach is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Guangzhou, Guangdong
- Nanfang Hospital, Southern Medical University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Wangjun Liao, MD, PhD — Nanfang Hospital, Southern Medical University
- Study coordinator: Wangjun Liao, MD, PhD
- Email: nfyyliaowj@163.com
- Phone: 86-20-62787731
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.