NCT06730503 Glycoprotein in Immunotherapy Response and Efficacy Prediction of Lung Cancer
| NCT ID | NCT06730503 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shanghai Chest Hospital |
| Condition | Non Small Cell Lung Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 250 participants |
| Start Date | 2023-10-01 |
| Primary Completion | 2027-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 250 participants in total. It began in 2023-10-01 with a primary completion date of 2027-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Immunotherapy has improved the prognosis of non-small cell lung cancer (NSCLC) patients, but about 80% of patients do not respond at all (primary resistance), and some patients initially respond to immunotherapy, later relapse and develop disease progression (acquired resistance). So the objective of this research is to explore the sugar chain heterogeneity of primary and acquired resistance to immunotherapy in patients with NSCLC.
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.
Frequently Asked Questions
Who can join the NCT06730503 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Non Small Cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06730503 currently recruiting?
Yes, NCT06730503 is actively recruiting participants. Visit ClinicalTrials.gov or contact Shanghai Chest Hospital to inquire about joining.
Where is the NCT06730503 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06730503 clinical trial?
NCT06730503 is sponsored by Shanghai Chest Hospital. The trial plans to enroll 250 participants.
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