Actively Recruiting
Low Dose Radiotherapy Combined With Sintilimab and Chemotherapy as Neoadjuvant Therapy for Stage II-III NSCLC
Led by Anhui Provincial Cancer Hospital · Updated on 2025-02-10
86
Participants Needed
1
Research Sites
131 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate efficacy and safety of low dose radiotherapy combined with sintilimab and platinum based chemotherapy as neoadjuvant therapy for stage II-III Non-Small Cell Lung Cancer
CONDITIONS
Official Title
Low Dose Radiotherapy Combined With Sintilimab and Chemotherapy as Neoadjuvant Therapy for Stage II-III NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and able to comply with study procedures
- Age 18 years or older
- Diagnosed with primary non-small cell lung cancer (adenocarcinoma or squamous cell carcinoma)
- Clinical stage IIB (tumor >4cm), IIIA, or IIIB (resectable N2 only) according to AJCC 8th edition
- Non-squamous NSCLC patients must test negative for EGFR sensitive mutations and ALK rearrangements; squamous NSCLC patients must not have these mutations if known
- Suitable for radical surgical resection
- Lung function adequate for planned lung surgery (FEV1 ≥ 50% predicted, MVV ≥ 50% predicted) with no surgical contraindications
- Able to provide tissue samples for PD-L1 testing during screening
- At least one measurable lesion per RECIST V1.1
- ECOG performance status 0 or 1
- No prior systemic anti-tumor therapy or local radiotherapy for NSCLC
- Adequate organ and bone marrow function with laboratory values meeting specified limits within 7 days before enrollment
- Negative pregnancy test for women of childbearing potential within 7 days before first study drug
- Use of highly effective contraception during study and for 180 days after treatment if at risk of conception
You will not qualify if you...
- Presence of small cell carcinoma, large cell neuroendocrine tumor, or sarcomatoid tumor components
- Tumor invasion into diaphragm, mediastinum, heart, pericardium, major blood vessels, trachea, recurrent laryngeal nerve, esophagus, vertebral body, or protuberance
- Tumor of the superior sulcus of the lung
- Tumor nodules in the opposite lung lobe without biopsy confirmation if suspected
- Confirmed or suspected brain metastases
- Current participation in other interventional clinical trials or recent use of investigational drugs/devices
- Prior use of immune checkpoint inhibitors or adoptive cell immunotherapy
- Recent use of certain Chinese herbal medicines or immunomodulatory drugs
- Major surgery within 4 weeks before randomization
- Unhealed surgical wounds, ulcers, or fractures
- Recent attenuated live vaccine use or planned during study
- Long-term systemic corticosteroid or immunosuppressive therapy
- History of non-infectious pneumonia requiring steroids or current interstitial lung disease
- Active autoimmune diseases requiring systemic treatment within 2 years
- Primary immunodeficiency
- History or presence of myocarditis
- Unresolved toxicity from prior treatments
- Grade 2 or higher peripheral neuropathy
- Bleeding or clotting disorders or recent thromboembolism
- Uncontrolled hypertension or hyperglycemia
- Unstable systemic diseases including infections, heart failure, serious arrhythmias, liver, kidney or metabolic disorders
- History of solid organ or blood system transplantation
- Known HIV infection or active syphilis
- Active tuberculosis or requiring treatment
- Active hepatitis B or C infection not meeting specified criteria
- Other cancers within 5 years except certain treated cancers
- Known allergy to study chemotherapy drugs
- Pregnant, breastfeeding, or planning pregnancy during study
- Mental illness, drug abuse, or history of alcohol abuse affecting compliance
- Any medical condition or history that may interfere with study participation or outcomes as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Anhui Provincial Cancer Hospital
Hefei, Anhui, China, 230001
Actively Recruiting
Research Team
S
Shuanghu Yuan, MD., PhD.
CONTACT
L
Li Li, MD., PhD.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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