Actively Recruiting
Adebrelimab Plus Chemo and Recaticimab in Perioperative Treatment of Resectable NSCLC
Led by Beijing Chest Hospital, Capital Medical University · Updated on 2024-12-16
35
Participants Needed
1
Research Sites
132 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Current studies confirmed that the immune perioperative treatment with combination chemotherapy curative effect and safety of resectable NSCLC, but its short-term curative effect and long-term survival benefit remains to be further improved to explore the new way of immune combination therapy. Experimental study showed that the inhibition of PCSK9 could significantly increase in tumor cells of the immune response in mice, inhibit the PCSK9 enhanced anti-tumor immune response of mice can be further coordinate with immune checkpoint therapy, forming a lasting anti-tumor immune effect. There are no reports on the peri-operative treatment of immune combined with chemotherapy and PCSK-9 inhibitors in patients with resectable NSCLC. Based on the above, the aim of this study is to explore the efficacy and safety of Adebrelimab combined with recaticimab and chemotherapy in the perioperative treatment of patients with resectable NSCLC.
CONDITIONS
Official Title
Adebrelimab Plus Chemo and Recaticimab in Perioperative Treatment of Resectable NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years, male or female
- ECOG performance status 0 or 1
- Histologically or cytologically confirmed operable stage II to III NSCLC (including stages II, IIIA, and T3N2M0 IIIB) as per UICC and AJCC 8th edition TNM system
- Non-massive metastases with lymph nodes 2 cm and expected complete resectable N2
- Measurable lesions according to RECIST 1.1 criteria (tumor lesion 210 mm or lymph node 215 mm on CT scan)
- No prior anti-tumor treatments such as radiotherapy, chemotherapy, surgery, or targeted therapy
- Sufficient lung function for R0 curative surgery
- Normal major organ function with blood counts and biochemistry meeting specified limits within 14 days prior to enrollment
You will not qualify if you...
- Known EGFR or ALK mutations
- T4 tumors invading critical structures such as heart, great vessels, trachea, nerves, esophagus, vertebral body, or upper sulcus lung cancer
- Use of immunosuppressive drugs within 4 weeks before first study dose, except certain corticosteroids
- Use of immune-regulating herbal medicines or drugs within 4 weeks before first study dose
- Other malignant tumors within 5 years before enrollment
- Live attenuated vaccine within 4 weeks before first dose or planned during study
- Participation in other clinical trials with invasive treatments within 4 weeks before first dose
- Severe infection or unexplained fever within 4 weeks before first dose
- History or suspicion of pneumonia, interstitial lung disease, or lung diseases affecting lung function testing
- Active autoimmune disease history (except controlled childhood asthma remission or vitiligo)
- Immune deficiencies such as HIV infection or active hepatitis B or C
- Significant heart disease or poor heart function
- Liver enzyme abnormalities or major bleeding/thrombotic events
- History of organ or stem cell transplantation
- Allergy or intolerance to study drugs or their ingredients
- Any condition that may harm the participant or prevent study completion as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Chest Hospital
Beijing, Beijing Municipality, China, 101125
Actively Recruiting
Research Team
J
Jinghui Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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