Actively Recruiting
Chemotherapy Plus Immunotherapy Combined With SBRT as Neoadjuvant Therapy for Patients With Resectable NSCLC
Led by First People's Hospital of Hangzhou · Updated on 2024-12-05
40
Participants Needed
1
Research Sites
261 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
In this study, patients with EGFR/ALK wild-type, resectable locally advanced NSCLC are expected to receive 1 cycle of chemoimmunotherapy as neoadjuvant therapy, followed by SBRT to the primary lung lesion, and chemoimmunotherapy for 2 cycles. Surgical treatment will be given within 4-6 weeks after the last cycle of chemoimmunotherapy, then immunotherapy maintenance for 1 year.
CONDITIONS
Official Title
Chemotherapy Plus Immunotherapy Combined With SBRT as Neoadjuvant Therapy for Patients With Resectable NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or pathologically confirmed, newly diagnosed non-small cell lung cancer patients
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
- Clinical stage II to IIIA NSCLC according to the 8th-9th edition AJCC; stage IIIB includes T3-4N2, T4 tumors over 7 cm
- EGFR and ALK mutation negative by biopsy or puncture samples
- Tumor surgically or potentially resectable as determined by a multidisciplinary team
- No prior systemic antitumor therapy or chest radiotherapy
- Presence of evaluable lesions in the lung or mediastinum
- Adequate organ function within 1 week before enrollment including bone marrow, liver, kidney, and serum albumin levels
- Male or female of childbearing potential agrees to use contraception during the trial
- Signed informed consent
You will not qualify if you...
- Severe dysfunction of heart, lungs, or other organs making surgery unsuitable
- Severe autoimmune diseases such as active inflammatory bowel disease, rheumatoid arthritis, scleroderma, systemic lupus erythematosus, or autoimmune vasculitis
- Other malignancies within the past 5 years except non-melanoma skin cancer or cervical cancer
- Active infection, heart failure, heart attack, unstable angina, or unstable arrhythmia within the last 6 months
- Congenital or acquired immunodeficiency including HIV or history of organ or stem cell transplantation
- Prior treatment with immunological agents, chemotherapy, other clinical trial drugs, or long-term corticosteroid therapy
- Allergy or contraindication to PD-1 inhibitors
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Department of Thoracic Oncology, Hangzhou Cancer Hospital
Hangzhou, Zhejiang, China, 310002
Actively Recruiting
Research Team
Y
Yi Tang
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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