Glycoprotein in Immunotherapy Response and Efficacy Prediction of Lung Cancer

NCT06730503 | Recruiting

• 1 other identifier: THORACIC006
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Non Small Cell Lung Cancer

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Objective response rate (ORR)

  The investigator (and the chief radiologist) used the RECIST 1.1 evaluation criteria to evaluate the efficacy indicators. CT or MRI imaging data of the chest and abdomen collected regularly during the screening/baseline period and the study period were used for tumor evaluation. Only when there may be primary or metastatic disease in the pelvis, pelvic imaging is recommended. Any other disease-affected areas (for example, the pelvis and brain) should undergo additional imaging studies based on the individual patient's signs and symptoms. If an unplanned evaluation is performed and it is shown that the patient has not progressed, follow-up evaluation should be performed at the next scheduled visit as much as possible. Scanning/tumor evaluation continued throughout the study period until RECIST 1.1 appeared

  Up to 5 years

• Progression-free survival (PFS)

  Calculate the time from the immunotherapy to the tumor progression/all-cause death/the end of the follow-up period.

  Up to 5 years

Secondary Outcomes (1)

• Overall survival (OS)

  Up to 5 years

Study Arms (1)

Anti-PD-1/PD-L1 monoclonal antibody

Drug: Immune checkpoint inhibitor

Interventions

Immune checkpoint inhibitor DRUG

Observe a situation before and after immunotherapy

Anti-PD-1/PD-L1 monoclonal antibody

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Chinese patients with advanced NSCLC patients receiving immunotherapy

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Chest Hospital: lead

Study Sites (1)

Xiaomin Niu

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

The blood specimens are stored in the refrigerator at -20°C or -80°C as specified in the clinical trial protocol. Test specimens and backup specimens should be kept in separate refrigerators to prevent malfunction of one of the refrigerators. Centrifugation time, specimen collection and specimen storage time should be carried out in strict accordance with the requirements of the clinical trial protocol.

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Immune Checkpoint Inhibitors

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: December 12, 2024
• Study Start: October 1, 2023
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): October 31, 2028
• Last Updated: December 12, 2024

Record last verified: 2024-12

Locations

CN (1)