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

NCT06232265 | Recruiting

• 1 other identifier: NFEC-2023-412
• Study Type: observational
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-small Cell Lung Cancer

Keywords

immunotherapy; LIRA score; biomarker

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

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

  3 years

Secondary Outcomes (4)

• Progression-free Survival (PFS)

  3 years

• Overall Survival (OS)

  3 years

• Duration of response (DoR)

  3 years

• Disease Control Rate (DCR)

  3 years

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients voluntarily participated in the study, signed the informed consent, and had good compliance;
• 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;
• Patients are willing to receive immunotherapy monotherapy or immunotherapy combined with chemotherapy;
• 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;
• The Eastern Organization for Oncology (ECOG) physical fitness score is 0 or 1;
• The patient has at least one measurable or unmeasurable but evaluable lesion.

You may not qualify if:

• According to clinical routine, patients do not meet the criteria for receiving standard anti-tumor treatment;
• Patients with known EGFR mutations, ALK rearrangements or ROS1 rearrangements are not eligible to participate in this study;
• According to the researcher's judgment, the patient is not suitable to participate in this study.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Wangjun Liao, MD, PhD

  Nanfang Hospital, Southern Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wangjun Liao, MD, PhD

CONTACT

86-20-62787731; nfyyliaowj@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: January 30, 2024
• Study Start: September 22, 2023
• Primary Completion: August 1, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: January 30, 2024

Record last verified: 2024-01

Locations

CN (1)