RecruitingPhase 3NCT07016126

D-BACE in Combination With Chemotherapy and Carelizumab for Resectable II-IIIA or Potentially Resectable T3-4N2 Stage IIIB NSCLC

Sponsor

Guangdong Provincial People's Hospital

Enrollment

70 participants

Start Date

Dec 22, 2024

Study Type

INTERVENTIONAL

Conditions

NSCLC (Non-small Cell Lung Cancer)

Summary

This study is a single-arm prospective single-center phase II study. Subjects are untreated resectable II-IIIIA or potentially resectable T3-4N2 stage IIIB NSCLC. 70 subjects will be enrolled in this prospective observation aimed at evaluating the clinical efficacy and safety of D-BACE in combination with neoadjuvant chemotherapy and carelizumab in patients with resectable II-IIIIA or potentially resectable T3-4N2 stage IIIB NSCLC. The treatment group regimen will be 3 cycles of D-BACE (DCB-loaded microspheres loaded with epirubicin 50 mg) in combination with chemotherapy and carelizumab (the specific regimen of chemotherapy will be determined by the investigator, and platinum-containing two-agent chemotherapy will generally be used). Adverse events will be monitored throughout the trial and graded for severity according to NCI CTCAE version 5.0. Tissue and blood specimens will be dynamically collected during the course of treatment for translational research.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of a targeted antibody-drug (D-BACE), chemotherapy, and an immunotherapy drug (carelizumab) given before surgery in patients with non-small cell lung cancer (NSCLC) that is either operable or potentially operable at an advanced local stage. **You may be eligible if...** - You are between 18 and 75 years old with confirmed NSCLC at stage II–IIIA or certain stage IIIB tumors - You have not received any prior treatment for this cancer - You are in good general health (ECOG 0 or 1) - Your organ function (blood counts, liver, kidneys) is adequate - Your doctors assess that your lungs can tolerate surgery after treatment **You may NOT be eligible if...** - You have received prior treatment for this lung cancer - You are pregnant or breastfeeding - You have significant organ dysfunction - Your tumor tissue cannot be provided for testing Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTD-BACE in combination with chemotherapy and karelizumab

3 cycles of D-BACE (DCB-loaded microspheres loaded with epirubicin 50 mg) in combination with chemotherapy and karelizumab (the specific regimen of chemotherapy is determined by the investigator, and platinum-containing two-agent chemotherapy is generally used).