Clinical trial · Observational
An Observational Study on Predicting the Efficacy of Immunotherapy for NSCLC Based on LIRAscore
An Observational Study on Predicting the Efficacy of Immunotherapy for Non-small-cell Lung Cancer Based on LIRAscore
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Objective Response Rate (ORR)
- timeFrame
- 3 years
- description
- Defined as the proportion of patients who achieved complete response (CR) or partial response (PR)
Secondary outcomes (4)
- measure
- Progression-free Survival (PFS)
- timeFrame
- 3 years
- description
- Defined as the time from first recieving treatment to the first occurrence of disease progression or death from any cause determined by IRC based on the Solid Tumor Efficacy Evaluation Criteria (RECIST) 1.1, whichever occurs first
- measure
- Overall Survival (OS)
- timeFrame
- 3 years
- description
- Defined as the time from first treatment to death for any reason.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available