Actively Recruiting
A Phase II Trial to Evaluate the Efficiency and Safety of Serplulimab Plus Chemotherapy as Conversion Treatment for Patients With Stage IIIB-IVA Oligometastatic Non-small Cell Lung Cancer
Led by Zhejiang University ยท Updated on 2023-07-17
49
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of Serplulimab combined with chemotherapy as a conversion treatment for patients with stage IIIB-IVA oligometastatic non-small cell lung cancer (NSCLC). This phase II, single-arm, open-label trial aims to determine how well this treatment can convert unresectable tumors into ones that can be surgically removed, and to assess progression-free survival and overall survival rates. The study also includes analysis to identify biomarkers that may predict treatment response. Participants with unresectable NSCLC will receive 3 to 4 cycles of Serplulimab plus chemotherapy every three weeks. The chemotherapy regimen includes carboplatin and either pemetrexed or nab-paclitaxel depending on cancer type. After this induction treatment, patients suitable for surgery will undergo curative pneumonectomy, while metastatic lesions may be treated with locoregional ablative therapies. Following surgery, maintenance treatment with PD-1 antibody will continue every three weeks for up to 12 months or until disease progression. During the study, participants will be closely monitored with evaluations including tumor response assessments up to 16 weeks and survival follow-up for up to five years. Researchers will measure outcomes such as the rate of tumors becoming resectable, progression-free survival at one year, major pathological response, pathological complete response, and overall survival. The study involves comprehensive clinical assessments and safety monitoring throughout the treatment and follow-up periods.
CONDITIONS
Brief Title
A Phase II Trial to Evaluate the Efficiency and Safety of Serplulimab Plus Chemotherapy as Conversion Therapy in NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must voluntarily agree to participate and sign informed consent
- Diagnosed with non-small cell lung cancer by cytology or histology without prior anti-tumor treatment
- Have stage IIIB to IVA oligometastatic NSCLC meeting specific criteria for tumor and metastases suitability
- Evaluated by a multidisciplinary team confirming upfront surgery is not preferred but feasible after induction treatment
- Age between 18 and 75 years, any gender
- ECOG performance status 0-1
- At least one measurable lesion according to RECIST v1.1
- Suspicious mediastinal lymph nodes require pathological confirmation
- Lung function sufficient for pneumonectomy
- Adequate organ function including blood counts and liver/kidney function within defined limits
- Women of childbearing potential must use contraception; men with partners of childbearing age must use effective contraception during the trial
You will not qualify if you...
- NSCLC patients with sensitive EGFR mutations, EML4-ALK fusion, or other ALK gene changes
- Prior treatment with immune checkpoint inhibitors such as PD-1/PD-L1/CTLA4 antibodies
- Other primary cancers within the past 3 years except certain skin or cervical cancers
- Active hepatitis B or C infection
- Active or history of autoimmune diseases
- Use of immunosuppressive agents or systemic hormone therapy
- Poorly controlled hypertension or cardiac symptoms
- Abnormal blood clotting parameters
- Recent arterial or venous thrombotic events within 6 months
- Active infections
- Congenital or acquired immune dysfunction including HIV
- Other medical factors that may affect study results or safety as judged by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 16 weeks for initial conversion treatment cycles; maintenance treatment continues up to 12 months or until disease progression after surgery
Participants receive 3 to 4 cycles of serplulimab plus chemotherapy as conversion treatment for their unresectable NSCLC. Afterwards, participants suitable for surgery undergo curative pneumonectomy, and locoregional ablative treatments are performed for metastatic lesions. Maintenance treatment with PD-1 antibody continues up to 12 months or until disease progression after surgery.
Treatment cycles every 3 weeks; maintenance visits every 3 weeks
Duration - Up to five years
Participants are monitored for progression-free survival and overall survival for up to five years following treatment.
Visits as scheduled for long-term monitoring
Trial Site Locations
Total: 1 location
1
Zhejiang University
Hangzhou, Zhejiang, China, 310058
Actively Recruiting
Research Team
P
Peng Zhao, MD
J
Jian Hu, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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