Non-small Cell Lung Cancer
Conditions
Keywords
immunotherapy, LIRA score, biomarker
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.
Interventions
None listed
Sponsors
Nanfang Hospital, Southern Medical University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | 3 years | Defined as the proportion of patients who achieved complete response (CR) or partial response (PR) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival (PFS) | 3 years | 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 |
| Overall Survival (OS) | 3 years | Defined as the time from first treatment to death for any reason. |
| Duration of response (DoR) | 3 years | Defined as the time from the first recorded objective remission to the disease progression determined by IRC according to RECIST version 1.1, or the time of death from any cause, whichever occurs first. |
| Disease Control Rate (DCR) | 3 years | Defined as the proportion of patients whose best overall efficacy (BOR) determined by IRC according to RECIST 1.1 is complete remission, partial remission, or disease stability |
Countries
China
Contacts
Primary ContactWangjun Liao, MD, PhD
Outcome results
None listed