Serplulimab Combined With Chemotherapy in Patients With Resectable Non-small-cell Lung Cancer
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Lung cancer group 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. Preoperative neoadjuvant therapy for 2-4 cycles, one cycle every 21 days. Surgical resection of lung cancer will be arranged about 4-8 weeks after the last cycle of neoadjuvant therapy. |
Drug: Serplulimab and neoadjuvant therapy
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.
Other Names:
Procedure: surgical resection of lung cancer
radical resection of lung cancer
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Pathological Complete Response (PCR) [1 month after surgery]
No residual invasive tumor cells were found in the pathological examination of resected specimens.
Secondary Outcome Measures
- Major Pathological Response (MPR) [1 month after surgery]
In the pathological examination of resected specimens, the proportion of residual tumor cells was less than 10%.
- Objective Response Rate (ORR) [before surgery]
The proportion of subjects with imaging PR or CR assessed according to RECIST 1.1 criteria
- 2-year and 5-year overall survival [2-year and 5-year after surgery]
The proportion of all study cases in which no death from any cause occurred within 2 years and 5 years after surgery
- Incidence of Treatment-related Adverse Events [1 month after surgery]
Incidence of Treatment-related Adverse Events as Assessed by CTCAE v5.0
- R0 resection rate [1 month after surgery]
The pathological results will showed that the incision margin was negative and no residual cancer cells were found under the microscope
Eligibility Criteria
Criteria
Inclusion Criteria:
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signed informed consent;
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patients age 18 to 75 years old
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primary resectable, histologically confirmed non small cell lung cancer;
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non small cell lung cancer the clinical stage was IIA-IIIB (no N3 patient) (according to AJCC TNM stage, 8th edition).
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ECOG PS 0-1.
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the diseases could be resectable assessed by thoracic oncologist
Exclusion Criteria:
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with significant cardiovascular disease;
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current treatment with anti-viral therapy or HBV;
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Female patients who are pregnant or lactating;
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history of malignancy within 5 years prior to screening;
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active or history of autoimmune disease or immune deficiency;
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signs of distant metastases.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 2nd Affiliated Hospital, School of Medicine, Zhejiang University | Hangzhou | China | 310009 |
Sponsors and Collaborators
- Second Affiliated Hospital, School of Medicine, Zhejiang University
Investigators
- Study Chair: Weilin Wang, 2nd Affiliated Hospital, School of Medicine, Zhejiang University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2023-0485