NCT06232265 An Observational Study on Predicting the Efficacy of Immunotherapy for NSCLC Based on LIRAscore
| NCT ID | NCT06232265 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nanfang Hospital, Southern Medical University |
| Condition | Non-small Cell Lung Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 108 participants |
| Start Date | 2023-09-22 |
| Primary Completion | 2025-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 108 participants in total. It began in 2023-09-22 with a primary completion date of 2025-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 participate in this study; 3. According to the researcher's judgment, the patient is not suitable to participate in this study.
Contact & Investigator
Wangjun Liao, MD, PhD
PRINCIPAL INVESTIGATOR
Nanfang Hospital, Southern Medical University
Frequently Asked Questions
Who can join the NCT06232265 clinical trial?
This trial is open to participants of all sexes, studying Non-small Cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06232265 currently recruiting?
Yes, NCT06232265 is actively recruiting participants. Contact the research team at nfyyliaowj@163.com for enrollment information.
Where is the NCT06232265 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT06232265 clinical trial?
NCT06232265 is sponsored by Nanfang Hospital, Southern Medical University. The principal investigator is Wangjun Liao, MD, PhD at Nanfang Hospital, Southern Medical University. The trial plans to enroll 108 participants.
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