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Construction of a Prognostic and Prediction Model for Perioperative Immunotherapy in NSCLC: A Multi - Omics Perspective

ConditionsNSCLC Stage IIIA/BNSCLC Stage II
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorZiming Li

About this trial

This research focuses on exploring biomarkers for the application of PD - 1/PD - L1 immune checkpoint inhibitors in the perioperative immunotherapy of lung cancer. Multi - index tests are conducted on tissues prior to treatment, as well as blood samples at baseline and during the treatment course. The goal is to identify biomarkers capable of predicting the efficacy of neoadjuvant and adjuvant immunotherapies. Additionally, by integrating these multiple - index data into models, patients are to be stratified based on their potential benefits from perioperative immunotherapy, providing personalized guidance for clinical decision - making.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

NSCLC, clinical tumor stage II-IIIB

Without EGFR/ALK gene mutation

Patient 18 years or older.

Scheduled for neoadjuvant immunotherapy.

Disqualifiers

With other cancers (excluding NSCLC or skin cancer other than melanoma, or cancers treated curatively with follow up of more than 5 years without recurrence).

With history of chemotherapy or radiotherapy (including pre - operative and post - operative adjuvant chemotherapy and radiotherapy) or systemic anti - tumor treatment.

with autoimmune diseases unsuitable for PD - 1 monoclonal antibody treatment, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, Guillain - Barré syndrome, or multiple sclerosis.

Patients who are unlikely to comply with the protocol (e.g. uncooperative attitude), inability to return for subsequent visits) and/or otherwise considered by the Investigator to be unlikely to complete the study.

Trial population

Patients with non - small cell lung cancer who are negative for driver genes such as EGFR and ALK and receive neoadjuvant immunotherapy

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

120 Participants
are grouped into 1 trial group
Group A: PD-1/PD-L1 neoadjuvant therapy group

Trial outcomes

Primary outcomes

1

Pathological response after immune neoadjuvant therapy

The primary evaluation indicators are pathological complete response (pCR) and major pathological response (MPR). MPR refers to the residual tumor cells in the surgically resected specimens being ≤ 10%, while pCR requires the complete disappearance of tumor cells.

Time frame
From enrollment to surgery at 18 weeks

Secondary outcomes

1

2-year Progression-Free Survival(PFS1)

Mainly evaluate the PFS of patients from the time of enrollment until two years later.

Time frame
PFS of patients from the time of enrollment until two years
2

2-year Progression-Free Survival(PFS2)

Mainly evaluate the patient's PFS from the start of adjuvant immunotherapy to 2 years.

Time frame
PFS from the start of adjuvant immunotherapy to 2 years.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ziming Li

Lead sponsor

Shanghai Chest Hospital

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: