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

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

Recruiting
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Phase N/A

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Overview

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.

Eligibility

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.

Study details
    Non-small Cell Lung Cancer

NCT06232265

Nanfang Hospital, Southern Medical University

16 February 2024

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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