Exploring sugar chains in lung cancer immunotherapy response

Sugar Chain Heterogeneity in Immunotherapy Response and Efficacy Prediction of Lung Cancer

This study is testing if changes in sugar chains in the blood can help predict how well people with non-small cell lung cancer respond to immunotherapy treatments.

Quick facts

• Study type: Observational
• Enrollment: 250 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shanghai Chest Hospital (other)
• Drugs / interventions: immunotherapy
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06730503 on ClinicalTrials.gov

What this trial studies

This research investigates the role of glycoprotein sugar chain heterogeneity in predicting the response to immunotherapy in patients with non-small cell lung cancer (NSCLC). It focuses on understanding both primary resistance, where patients do not respond to treatment, and acquired resistance, where patients initially respond but later relapse. The study involves collecting blood samples from patients undergoing immune checkpoint inhibitor treatment to analyze the changes in glycosylation patterns associated with these resistance mechanisms. By identifying disease-specific biomarkers, the research aims to improve treatment strategies for NSCLC patients.

Who should consider this trial

Good fit: Ideal candidates include patients with advanced non-small cell lung cancer who are receiving immune checkpoint inhibitor treatment and can provide blood samples.

Not a fit: Patients with early-stage lung cancer or those not receiving immunotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to better prediction of immunotherapy responses in lung cancer patients, potentially improving treatment outcomes.

How similar studies have performed: While the exploration of glycoprotein markers in cancer treatment is a growing field, this specific approach to understanding immunotherapy resistance in NSCLC is relatively novel.

Eligibility criteria

Inclusion Criteria:

* Be able to provide informed consent, and understand and agree to follow the research requirements;
* Advanced non-small cell lung cancer;
* Patients receiving immune checkpoint inhibitor treatment represented by anti-PD-1/PD-L1 monoclonal antibody;
* The patient must be able to provide 10mL peripheral whole blood samples before- and after- ICIs;
* ECOG physical fitness status ≤1;
* The patient must have at least one measurable lesion (assessed according to RECIST v1.1);
* Life expectancy ≥ 12 weeks;
* The patient must have adequate organ function, and must be reached absolute neutrophil count (ANC) ≥1.5x10\^9/L, platelets ≥100x10\^9/L, hemoglobin ≥90g/L, international normalized ratio (INR) or prothrombin time ≤ 1.5x ULN , activated partial thromboplastin time (aPTT)≤1.5x ULN, serum total bilirubin≤1.5x ULN (Patients with Gilbert syndrome can be enrolled if total bilirubin\<3x ULN), Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤2.5x ULN(Patient with liver metastases, this standard is AST and ALT≤5x ULN) within 7 days before treatment;

Exclusion Criteria:

* Patients with other tumors. Except for basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin or cervical cancer in situ, subjects who have received potential radical treatment and have not relapsed within 5 years before the start of treatment can be included in the study;
* Have received any approved systemic anti-tumor immunotherapy before starting the research treatment;
* A history of interstitial lung disease, non-infectious pneumonia or uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung disease, etc.;
* Severe chronic or active infections that require systemic antibacterial, antifungal or antiviral therapy, including tuberculosis infection;
* Known human immunodeficiency virus infection; previous allogeneic stem cell transplantation or organ transplantation;
* The investigator judged that the patient's compliance during the study period was insufficient.

Where this trial is running

Shanghai, Shanghai Municipality

• Xiaomin Niu — Shanghai, Shanghai Municipality, China (RECRUITING)

Conditions: Non Small Cell Lung Cancer, immunotherapy, Immune checkpoint inhibitors, PD-L1, resistance, sugar chain heterogeneity, glycoprotein