West China Hospital of Sichuan University
Chengdu, China, 610041
Location status: Recruiting
NCT Number: NCT06877299
This phase II study aims to evaluate the efficacy and safety of low-dose radiation + SBRT + Tislelizumab plus platinum-based chemotherapy as neoadjuvant therapy for stage II-III non-small cell lung cancer.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Phase 2
Chengdu, China, 610041
Location status: Recruiting
All eligible patients will receive LDRT combined with partial SBRT, followed by PD-1 inhibitors plus platinum-based chemotherapy, initiated within 7 days after completing radiation. PD-1 inhibitors and chemotherapy will be administered at the recommended doses according to the instruction manual every 3 weeks, with 3 cycles planned as neoadjuvant therapy. Surgery will be performed within 4 to 6 weeks (+7 days) after completing the final cycle of immunochemotherapy.
Main objective and endpoint: the rate of pathological complete response (pCR) in the resected primary tumor and lymph nodes.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Low-Dose Radiation(LDRT) + Stereotactic body radiotherapy (SBRT)
Other names: Drug: Tislelizumab, Drug: Chemotherapy
Time frame: From date of enrollment until one month after resection
pCR is defined as the absence of residual invasive cancer on hematoxylin and eosin stained slides of the resected lung specimen and lymph nodes following completion of neoadjuvant therapy
Time frame: From date of enrollment until one month after resection
mPR is defined as ≤10% viable tumor cells in the resected primary tumor and all resected lymph nodes.
Time frame: From date of enrollment until one month after resection
Time frame: up to 2 years
EFS is defined as the time from enrollment to radiographic disease progression, local progression precluding surgery, inability to resect the tumor, local or distant recurrence, or death due to any cause.
Contact information is provided by the study sponsor or research team.
Jianxin Xue, MD. Phd
CONTACT
You Lu, MD. PhD
CONTACT
Sichuan University
Other
Low-Dose Radiation + Stereotactic Body Radiotherapy Followed by Tislelizumab Plus Platinum-based Chemotherapy As Neoadjuvant Therapy in Patients With Resectable StageⅡA-ⅢB Non-small Cell Lung Cancer
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
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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