Shandong Cancer Hospital and Institute
Jinan, Shandong, 250117, China
Location status: Recruiting
Location contact
Guoxin Cai, MD
CONTACT
Xue Meng, MD, PhD
CONTACT
NCT Number: NCT06241807
This study aims to evaluate the efficacy and safety of neoadjuvant camrelizumab combined with chemotherapy in resectable stage IIIA and IIIB (T3-4N2) non-small cell lung cancer (NSCLC) patients. Inclusion criteria are: age 18-75, pathologically confirmed resectable stage IIIA-IIIB (T3-4N2) NSCLC, absence of EGFR, ALK, and ROS1 gene mutations, and Eastern Cooperative Oncology Group (ECOG) status 0-1. All patients receive three cycles of camrelizumab combined with platinum-based doublet chemotherapy, followed by curative surgery within 4-6 weeks after completion of chemotherapy. Patients undergo 18F-fluorodeoxyglucose (FDG) PET/CT scans in 1 week before treatment and 1 week before surgery, and peripheral blood samples are collected for biomarker analysis. The primary endpoints for follow-up are pathologic complete response (pCR) rate and major pathological response (MPR) rate, while secondary endpoints include safety and progression-free survival. Exploratory endpoints include molecular imaging research and biomarker analysis.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Phase 2
Jinan, Shandong, 250117, China
Location status: Recruiting
Guoxin Cai, MD
CONTACT
Xue Meng, MD, PhD
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients were assigned to receive 3 cycles of camrelizumab (200 mg) plus chemotherapy (nab-paclitaxel, 130 mg/m2 or pemetrexed (for adenocarcinoma), 500mg/m2 plus platinum [cisplatin, 75 mg/m2; carboplatin, area under the curve, 5])
Time frame: From date of surgery to 14 days later
No more than 10% of tumor cells were found in neoadjuvant surgical specimens
Time frame: From date of surgery to 14 days later
No histological evidence of malignancy was found in the primary tumor and metastatic lymph nodes
Time frame: 24 weeks
Number and percentage of cases of all adverse events
Time frame: 24 months
The period of time from the initiation of treatment to the observation of disease progression or occurrence of death for any reason
Time frame: 20 weeks
Plasma ctDNA testing, serum metabolomics testing, 18F-FDG uptake value, circulating immunological biomarkers, and observation of tumor immune microenvironment
Contact information is provided by the study sponsor or research team.
Guoxin Cai, MD
CONTACT
Xue Meng, MD, PhD
CONTACT
Shandong Cancer Hospital and Institute
Other
A Phase II Trial of Neoadjuvant Camrelizumab Combined With Chemotherapy for Resectable Stage IIIA-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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