Non-small Cell Lung CancerNCT06232265
An Observational Study on Predicting the Efficacy of Immunotherapy for NSCLC Based on LIRAscore
An observational study of Non-small Cell Lung Cancer, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Non-small Cell Lung Cancer
- How many people
- 108 participants
- Where
- 1 siteChina
- Study dates
- 22 Sep 2023to 1 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515
Wangjun Liao, MD, PhD, 86-20-62787731, nfyyliaowj@163.com
Wangjun Liao, MD, PhD
About this study
Official title: An Observational Study on Predicting the Efficacy of Immunotherapy for Non-small-cell Lung Cancer 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.
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- immunotherapy, LIRA score, biomarker
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Defined as the proportion of patients who achieved complete response (CR) or partial response (PR)
Measured: 3 years
Secondary outcomes (4)
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
Measured: 3 years
Overall Survival (OS)
Defined as the time from first treatment to death for any reason.
Measured: 3 years
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.
Measured: 3 years
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
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start22 Sep 2023
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wangjun Liao, MD, PhD, Principal investigator, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06232265
- Sponsor's protocol ID
- NFEC-2023-412
- Status last verified
- Jan 2024
- First submitted
- 22 Jan 2024
- Last updated
- 30 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study on Predicting the Efficacy of Immunotherapy for Non-small-cell Lung Cancer Based on LIRAscore
- ClinicalTrials.gov ID
- NCT06232265
- Acronym / sponsor ID
- NFEC-2023-412
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- immunotherapy, LIRA score, biomarker
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 22 Sep 2023 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 30 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Objective Response Rate (ORR)
Time frame: 3 years
Defined as the proportion of patients who achieved complete response (CR) or partial response (PR)
4 secondary outcomes
Progression-free Survival (PFS)
Time frame: 3 years
Overall Survival (OS)
Time frame: 3 years
Duration of response (DoR)
Time frame: 3 years
Disease Control Rate (DCR)
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wangjun Liao, MD, PhD principal investigator
Nanfang Hospital, Southern Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-small Cell Lung Cancer, run by Nanfang Hospital, Southern Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wangjun Liao, MD, PhD (86-20-62787731, nfyyliaowj@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024.