Neoadjuvant Intra-tumor Double Immunotherapy for Lung Cancer.

Sponsor
Second Affiliated Hospital of Guangzhou Medical University
Study ID
NCT06492421
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • ipilimumab, pembrolizumab, durvalumab, idarubicin, bevacizumab — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jul 1, 2024
Status verified
Jul 2024
Primary completion
Dec 30, 2028
Completion
Dec 30, 2035

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1: IT injection of double ICIs
    Neoadjuvant therapy: intra-tumor injection of double ICIs only.
  • Experimental: Group 2: IT injection of double ICIs and chemodrug
    Neoadjuvant therapy: intra-tumor injection of double ICIs and chemodrug.
  • Experimental: Group 3: IT injection of double ICIs and chemodrug plus bevacizumab
    Neoadjuvant therapy: intra-tumor injection of double ICIs and chemodrug plus bevacizumab.

Primary Outcome Measure

pCR rate for the study groups [ Time Frame: Six months ]

Central Contacts

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