Zibo Municipal Hospital
Zibo, Shandong, 250000, China
Location status: Recruiting
NCT Number: NCT07085182
In clinical practice, some patients cannot tolerate concurrent chemoradiotherapy. The purpose of this study is to observe the efficacy and safety of Tislelizumab combined with platinum-based doublet chemotherapy followed by hypofractionated radiotherapy and Tislelizumab in patients with stage IIIB/C-IV non-squamous non-small cell lung cancer. This study aims to provide more treatment options for patients with locally advanced non-small cell lung cancer.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Phase 2
Zibo, Shandong, 250000, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
SBRT:3-10Gy/F, once daily, 5 times a week; Tislelizumab(200mg,iv,q3w):Tislelizumab was added after five sessions of SBRT radiotherapy.
Time frame: Up to approximately 30 months
PFS is defined as the time from the first dose until the first documentation of progression or death from any cause, whichever occurs first, as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame: Up to approximately 30 months
ORR is defined as the percentage of participants with complete response (CR) or partial response (PR), as assessed by the investigator using RECIST v1.1.
Time frame: Up to ~60 months
OS is defined as the time from first dose until the date of death due to any cause
Time frame: Up to ~24 months
DCR is defined as the percentage of participants with complete response (CR) or partial response (PR) or stable disease (SD), as assessed by the investigator using RECIST v1.1.
Time frame: Through study completion, an average of 2 year
The incidence and severity of AEs will be determined according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0).
Contact information is provided by the study sponsor or research team.
Zibo Municipal Hospital
Other
Tislelizumab Combined With sCRT in Stage IIIB/C-IV Non-Squamous 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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