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RecruitingNCT06232265Updated Jan 30, 2024

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

An observational study in Non-small Cell Lung Cancer, sponsored by Nanfang Hospital, Southern Medical University. Recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2024-01-30.

Sponsored by Nanfang Hospital, Southern Medical University · Observational

From the registry’s dates

  • Primary completion was expected by Aug 2025, 1 year 2 months ago, but the record still lists the study as recruiting.
  • Started Sep 2023; still recruiting 3 years later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
108
Sex
All
01

Study 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.

02

Conditions studied

  • Non-small Cell Lung Cancer

Keywords

  • immunotherapy
  • LIRA score
  • biomarker
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 108 is below the median of 189 across 1,514 observational studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Nanfang Hospital, Southern Medical University is the lead sponsor of 480 studies on the registry; 212 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

The subjects of this study were patients with previously untreated, locally advanced or metastatic non-small-cell lung cancer (stage IIIB/IIIC or stage IV) without driver gene mutation.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
108 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Objective Response Rate (ORR)

    Defined as the proportion of patients who achieved complete response (CR) or partial response (PR)

    Time frame: 3 years

Secondary outcomes

  1. Progression-free Survival (PFS)

    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

    Time frame: 3 years

  2. Overall Survival (OS)

    Defined as the time from first treatment to death for any reason.

    Time frame: 3 years

  3. Duration of response (DoR)

    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.

    Time frame: 3 years

  4. Disease Control Rate (DCR)

    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

    Time frame: 3 years

07

Study locations

1 of 1 sites recruiting
  • Nanfang Hospital, Southern Medical University
    Guangzhou, Guangdong 510515, China
    • Wangjun Liao, MD, PhD · Contact · nfyyliaowj@163.com · 86-20-62787731
    • Wangjun Liao, MD, PhD · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 30, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06232265
Lead sponsor
Nanfang Hospital, Southern Medical University
Responsible party
Sponsor
First posted
Jan 30, 2024
Start date
Sep 22, 2023
Primary completion
Aug 1, 2025 (estimated)
Completion
Aug 1, 2026 (estimated)
Last update
Jan 30, 2024

Study contacts

Wangjun Liao, MD, PhD
Contact
nfyyliaowj@163.com
86-20-62787731
Wangjun Liao, MD, PhD
principal investigator · Nanfang Hospital, Southern Medical University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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