Department of Thoracic Oncology, Hangzhou Cancer Hospital
Hangzhou, Zhejiang, 310002, China
Location status: Recruiting
NCT Number: NCT06718309
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 2
Hangzhou, Zhejiang, 310002, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients with squamous cell carcinoma can choose paclitaxel + cisplatin/carboplatin and patients with nonsquamous cell carcinoma can choose pemetrexed + cisplatin/carboplatin. The chemotherapy treatment lasts 3 cycles.
Investigators choose PD-1 or PD-L1 according to drug indication and the immunotherapy lasts 3 cycles preoperatively and 1 year after surgery.
Radical resection of lung cancer with lymph node dissection
SBRT for primary lung lesion 8Gy*3F after first cycle of chemoimmunotherapy
Time frame: Assessed up to 24 weeks
Pathological complete response for surgical patients
Time frame: Assessed up to 24 weeks
No more than 10% residual viable tumour in the resected tumour (up to 24 weeks)
Time frame: Assessed up to 100 months
Interval between the start of neoadjuvant treatment and any progression of disease precluding surgical resection, progression of disease in the absence of surgery, progression or recurrence after surgery, or death from any cause, whichever occurred first
Time frame: Assessed up to 24 weeks
The proportion of patients who had complete surgical resection [R0]
Time frame: assessed up to 100 months
The incidence of adverse events ≥ grade 3 during perioperative period
Contact information is provided by the study sponsor or research team.
First People's Hospital of Hangzhou
Other
A Prospective Cohort Study of Chemotherapy Plus Immunotherapy Combined With Stereotactic Body Radiotherapy as Neoadjuvant Therapy for Patients With Resectable Non-small Cell Lung Cancer
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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