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NCT Number: NCT06232265

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

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.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

Location status: Recruiting

Location contact

Wangjun Liao, MD, PhD

CONTACT

[email protected]

86-20-62787731

Wangjun Liao, MD, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Objective Response Rate (ORR)

    Time frame: 3 years

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

Secondary outcomes

  1. Progression-free Survival (PFS)

    Time frame: 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

  2. Overall Survival (OS)

    Time frame: 3 years

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

  3. Duration of response (DoR)

    Time frame: 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.

  4. Disease Control Rate (DCR)

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Wangjun Liao, MD, PhD

CONTACT

[email protected]

86-20-62787731

Sponsors and collaborators

Lead sponsor

Nanfang Hospital, Southern Medical University

Other

Registry information

Official study title

An Observational Study on Predicting the Efficacy of Immunotherapy for Non-small-cell Lung Cancer Based on LIRAscore

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Jan 30, 2024
Registry last updated
Jan 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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