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Trial Title:
Serplulimab Combined With Chemotherapy in Patients With Resectable Non-small-cell Lung Cancer
NCT ID:
NCT05882513
Condition:
NSCLC
Neoadjuvant Therapy
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Conditions: Keywords:
serplulimab
Non small cell lung cancer
Neoadjuvant Therapy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Serplulimab and neoadjuvant therapy
Description:
Squamous cell carcinoma: Serplulimab: 4.5mg/kg, i.v, day1; albumin paclitaxel 260mg/m2,
day1; carboplatin AUC=5, i.v, day1.
Non-squamous cell carcinoma: Serplulimab: 4.5mg/kg, i.v, day1 ; pemetrexed 500mg/m2, day1
; carboplatin AUC=5, i.v, day1.
Arm group label:
Lung cancer group
Other name:
Serplulimab
Intervention type:
Procedure
Intervention name:
surgical resection of lung cancer
Description:
radical resection of lung cancer
Arm group label:
Lung cancer group
Other name:
Surgery
Intervention type:
Other
Intervention name:
Tumour will be Collected from participant. Fate of sample is Destruction after use
Description:
Tumour sample will be collected after surgery
Arm group label:
Lung cancer group
Summary:
China with high incidence of non-small cell lung cancer. In the past few decades,
surgery, radiotherapy, chemotherapy and other treatments were continuously improved,
however, the mortality of lung cancer patients was not significantly decreased. For
patients with locally advanced lung cancer, direct surgery is not effective. It is
difficult to achieve radical resection by surgery merely, and even if many patients
receive surgery, they may eventually have tumor recurrence and poor survival rate.
Therefore, it is necessary to explore effective perioperative neoadjuvant treatment to
reduce the risk of postoperative recurrence and improve the postoperative survival rate
of patients. According to the reports, PD-1/ PD-L1 immunocheckpoint inhibitor may become
a new method for the treatment of lung cancer. Preliminary clinical results showed that
immunotherapy combined with chemoradiotherapy provided a synergies antitumor effect.
Multiple clinical results showed that serplulimab provided higher overall response rate
for advanced lung cancer. However, in patients with locally advanced lung cancer, the
efficacy of serplulimab combined with chemotherapy for sequential radical surgery is
still unclear. The purpose of this study is to observe and evaluate the efficacy and
safety of serplulimab combined with chemotherapy in the neoadjuvant therapy of resectable
non-small cell lung cancer.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. signed informed consent;
2. patients age 18 to 75 years old
3. primary resectable, histologically confirmed non small cell lung cancer;
4. non small cell lung cancer the clinical stage was IIA-IIIB (no N3 patient)
(according to AJCC TNM stage, 8th edition).
5. ECOG PS 0-1.
6. the diseases could be resectable assessed by thoracic oncologist
Exclusion Criteria:
1. with significant cardiovascular disease;
2. current treatment with anti-viral therapy or HBV;
3. Female patients who are pregnant or lactating;
4. history of malignancy within 5 years prior to screening;
5. active or history of autoimmune disease or immune deficiency;
6. signs of distant metastases.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Address:
City:
Hangzhou
Zip:
310009
Country:
China
Status:
Recruiting
Contact:
Last name:
Ming Wu, M.D
Phone:
+8613757118715
Email:
iwuming22@zju.edu.cn
Start date:
May 16, 2023
Completion date:
May 31, 2030
Lead sponsor:
Agency:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Agency class:
Other
Source:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05882513
