Actively Recruiting
Neoadjuvant Intra-tumor Double Immunotherapy for Lung Cancer.
Led by Second Affiliated Hospital of Guangzhou Medical University · Updated on 2024-07-09
90
Participants Needed
1
Research Sites
599 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Neoadjuvant Intra-tumor Double Immunotherapy for Lung Cancer.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed previously untreated non-small cell lung cancer
- Stage IIIA patients must have no more than one mediastinal lymph node station involved
- All patients must have lymph node evaluation of contralateral stations 2 and/or 4 to exclude N3 disease
- Suitable candidate for surgery as determined by the treating physician
- Signed informed consent provided prior to study admission
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Adequate blood counts and organ function: ANC \u2265 1.5 x 10^9/L; Hemoglobin \u2265 8.0 g/dL; Platelets \u2265 100 x 10^9/L; Total bilirubin \u2264 1.5 x ULN (or < 3.0 mg/dL in Gilbert syndrome); Creatinine \u2264 1.5 x ULN or creatinine clearance \u2265 50 mL/min
You will not qualify if you...
- Prior systemic therapy or radiation therapy for current lung cancer
- Currently receiving any cancer therapy or investigational anti-cancer drugs
- Pregnant or breastfeeding female
- Unwilling or unable to follow protocol procedures
- Pre-existing sensorineural hearing impairment or recent diagnosis affecting cisplatin use
- History of severe hypersensitivity to taxotere or polysorbate 80
- Serious or uncontrolled medical disorders increasing risk or interfering with treatment
- Active, known or suspected autoimmune diseases, except some controlled conditions
- Need for systemic corticosteroids (> 10 mg prednisone daily) or immunosuppressive drugs within 14 days
- Prior treatment with anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies
- Positive hepatitis B or C infection
- Positive HIV or AIDS diagnosis
- History of severe hypersensitivity to monoclonal antibodies or study drug components
- Serious non-cancer illness or lab abnormalities making participation unsafe
- Psychological, familial, social, or geographic factors limiting compliance
- Allergy to contrast agents
- Use of agents affecting absorption or pharmacokinetics of study drugs
- Other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The Second Affiliated Hospital of Guangzhou Medical University
Guanzhou, Guangdong, China, 51260
Actively Recruiting
Research Team
Z
Zhenfeng Zhang, MD, PhD
CONTACT
B
Bingjia He, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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