RecruitingPhase 2NCT06492421

Neoadjuvant Intra-tumor Double Immunotherapy for Lung Cancer.

Phase II Study of Neoadjuvant CT-Guided Intra-tumor Double Checkpoint Blockades for Untreated Stage I-IIIA Non-Small Cell Lung Cancers Amenable for Surgical Resection

Sponsor

Second Affiliated Hospital of Guangzhou Medical University

Enrollment

90 participants

Start Date

Jul 1, 2024

Study Type

INTERVENTIONAL

Conditions

Surgery Lung Cancer Non-small Cell Lung Cancer

Summary

This phase II trial studies how well intra-tumor injection of double checkpoint inhibitors work when given alone and in combination with chemotherapy or/and bevacizumab in treating patients with previously untreated stage I-IIIA non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as ipilimumab, pembrolizumab or durvalumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Drugs used in interventional radiological chemotherapy, such as idabubicin, can directly kill the cancer cell and release tumor antigens to activate DC function in situ. Giving intra-tumor injection of checkpoints inhibitors with or without chemotherapy and/or bevecizumab may work better than in vein infusion of the drugs in treating patients with non-small cell lung cancer.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether injecting two immunotherapy drugs directly into lung tumors before surgery improves outcomes in people with non-small cell lung cancer (NSCLC) that can potentially be removed surgically. The approach aims to activate the immune system locally before the tumor is removed. **You may be eligible if...** - You have confirmed non-small cell lung cancer that has not been previously treated - Your cancer is potentially operable (up to stage IIIA, with limited lymph node involvement) - You are a suitable surgical candidate in your doctor's opinion - Your lung function and organ health are adequate **You may NOT be eligible if...** - Your cancer has spread too extensively to nearby lymph nodes (N3 disease) - You have had prior treatment for this lung cancer - You have active autoimmune disease - You are pregnant or breastfeeding 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

DRUGipilimumab, pembrolizumab, durvalumab, idarubicin, bevacizumab

This study has 3 subgroups: Arm 1. Ipilimumab +pembrolizumab or Ipilimumab +durvalumab is administrated with a total dose of 1-2mg/kg via intra-tumor fine needle injection in 10 min, every 3 weeks, total 3-4 times. Arm 2. Ipilimumab +pembrolizumab or Ipilimumab +durvalumab combined with idarubicin is administrated via intra-tumor fine needle injection in 15 min, every 3 weeks, total 3-4 times. Arm 3. Ipilimumab +pembrolizumab or Ipilimumab +durvalumab combined with idarubicin plus bevacizumab is administrated via intra-tumor fine needle injection in 20 min, every 3 weeks, total 3-4 times.

Locations(1)

The Second Affiliated Hospital of Guangzhou Medical University

Guanzhou, Guangdong, China

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NCT06492421

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