Actively Recruiting
A Study Comparing Neoadjuvant Chemoimmunotherapy and Immuno-consolidationafter Compared With Immunoconsolidation After Radical Chemoradiotherapy for Stage III Potentially Resectable NSCLC
Led by Zeng Jian · Updated on 2024-05-22
92
Participants Needed
1
Research Sites
188 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate the efficacy and safety adebrelimab in Combination with chemotherapy after 3 cycles as neoadjuvant therapy and surgery or chemoradiotherapy based on MDT compared with adebrelimab after chemoradiotherapy in potentially operable stage III NSCLC.
CONDITIONS
Official Title
A Study Comparing Neoadjuvant Chemoimmunotherapy and Immuno-consolidationafter Compared With Immunoconsolidation After Radical Chemoradiotherapy for Stage III Potentially Resectable NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years old
- Histologically or cytologically confirmed non-small cell lung cancer without EGFR/ALK mutations if adenocarcinoma
- Stage IIIA-IIIB (T1-4N2M0) disease according to AJCC 8th Edition with specific lymph node features
- Tumors and lymph nodes evaluated as potentially resectable by multidisciplinary team
- Presence of measurable target lesions per RECIST 1.1 criteria
- ECOG performance status score of 0 or 1
- No previous history of other malignant tumors
- No prior anti-tumor therapy for NSCLC including surgery, radiotherapy, chemotherapy, targeted therapy, or immunotherapy
- Adequate cardiopulmonary function with FEV1 and DLCO ≥50%, LVEF ≥55%, and no significant heart disease
- Adequate organ function including specified bone marrow, coagulation, liver, and kidney parameters
- Fertile patients must agree to effective contraception during and up to 180 days after study drug administration
- Negative pregnancy test for women of reproductive potential within 7 days before first study drug administration
- Voluntary participation with informed consent signed
You will not qualify if you...
- Lesions deemed unresectable by surgery
- Active or history of autoimmune diseases requiring medical intervention, except certain stable conditions
- Congenital or acquired immune deficiency, including HIV infection or active hepatitis B or C
- Presence of uncontrollable pleural, pericardial effusion, or ascites
- Use of systemic corticosteroids (>10 mg/day prednisone or equivalent) or immunosuppressants within 14 days prior to treatment
- Treatment with anti-tumor vaccines or immunostimulatory drugs within 1 month before first dose
- Participation in another clinical study with recent dosing within 4 weeks or 5 half-lives
- Evidence of pulmonary fibrosis, interstitial lung disease, pneumoconiosis, drug-induced pneumonia, or severe lung impairment
- Major surgery, open biopsy, or significant trauma within 28 days prior to enrollment
- History of allogeneic organ or hematopoietic stem cell transplantation
- Pregnancy or breastfeeding, or unwillingness/inability to use contraception
- Known allergies or intolerances to study drugs
- Any other condition deemed inappropriate for study participation by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022
Actively Recruiting
Research Team
J
Jian Zeng, MD&PhD
CONTACT
T
Taobo Luo, MD&PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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