NCT05837052 A Phase II Trial to Evaluate the Efficiency and Safety of Serplulimab Plus Chemotherapy as Conversion Therapy in NSCLC
| NCT ID | NCT05837052 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Zhejiang University |
| Condition | Unresectable Lung Non-Small Cell Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 49 participants |
| Start Date | 2023-05-15 |
| Primary Completion | 2025-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 49 participants in total. It began in 2023-05-15 with a primary completion date of 2025-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a phase II, single-arm study to evaluate the efficacy and safety of Serplulimab plus chemotherapy as conversion treatment in patients with stage IIIB-IVA oligometastatic non-small cell lung cancer.
Eligibility Criteria
Inclusion Criteria: 1. Patients should voluntarily join this study and sign the informed consent form 2. NSCLC patients diagnosed by cytology or histology and not previously receiving anti-tumor treatments (including systemic treatments, local treatments .etc) 3. Patients with IIIB - IVA oligometastatic NSCLC : (a) IIIB - IIIC stage (T1-4N2-3): patients are not suitable or refuse to receive upfront surgical resection or radiotherapy; (b) oligometastatic stage IV (T1-3N0-2): radical resection/radiotherapy is feasible for metastatic lesions (the number of metastases being up to 3, and the maximum diameter of metastases being up to 2cm) 4. After evaluation by MDT, upfront surgical resection is not the preferred treatment, but after induction systemic treatments, radical resection of the primary tumor is feasible, and radical resection/radiotherapy is feasible for extrathoracic metastases (if any) 5. Age from 18 to 75 years old, both male and female 6. ECOG score 0-1 7. According to the RECIST v1.1 , patients should have at least one measurable lesion 8. For suspicious mediastinal lymph nodes (including pathological enlargement or PET-CT indicating malignancy, etc.), further sampling is required for pathological diagnosis by EUBS, thoracoscopy, or mediastinoscopy 9. According clinical evaluation, the lung function of patients (such as FVC, FEV1, TLC, FRC, DLco, etc.) should be sufficient for pneumonectomy 10. The function of important organs should meet the following requirements: absolute count of neutrophils ≥ 1.5 × 109/L； Platelets ≥ 100 × 109/L； Hemoglobin ≥ 90g/L; Serum albumin ≥ 35g/L; Thyroid hormone (TSH) ≤ 1 × ULN； Serum bilirubin ≤ 1.5 × ULN； ALT and AST ≤ 3 × ULN； International standardized ratio (INR) ≤ 1.5 or prothrombin time (PT) ≤ 1.5 × ULN； Serum creatinine ≤ 1.5 × ULN 11. Female patients at childbearing age are required to use contraceptive measures; for male patients whose partners are women at childbearing age, effective methods of contraception should be used during the trial period Exclusion Criteria: Patients who meet any of the following conditions will not be enrolled in this study: 1. NSCLC patients have sensitive EGFR mutation, EML4-ALK fusion or other forms of ALK gene changes 2. Patients have previously received immune checkpoint inhibitors such as PD-1/ PD-L1/CTLA4 antibody 3. Patients with other primary malignancies within the past 3 years (excluding cured skin basal cell carcinoma and cervical carcinoma in situ) 4. Patients with active hepatitis B/C 5. Patients with any active autoimmune diseases or a history of autoimmune diseases 6. Patients who are using immunosuppressive agents or require systemic hormone therapy 7. Patients with hypertension but without good control even through antihypertensive medication treatment ; patients with clinical symptoms or diseases related to unsatisfying cardiac function 8. Patients with abnormal coagulation function (INR\>2.0, PT\>16s) 9. Arterial/venous thrombotic events occurred before screening within 6 months 10. Patients with active infection 11. Patients with congenital or acquired immune dysfunction (such as HIV infection) 12. According to the judgment of the researchers, patients have other factors that may affect the results of the research or cause the research to be terminated
Contact & Investigator
Weijia Fang, MD
PRINCIPAL INVESTIGATOR
First Affiliated Hospital of Zhejiang University
Frequently Asked Questions
Who can join the NCT05837052 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Unresectable Lung Non-Small Cell Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05837052 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05837052 currently recruiting?
Yes, NCT05837052 is actively recruiting participants. Contact the research team at zhaop@zju.edu.cn for enrollment information.
Where is the NCT05837052 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT05837052 clinical trial?
NCT05837052 is sponsored by Zhejiang University. The principal investigator is Weijia Fang, MD at First Affiliated Hospital of Zhejiang University. The trial plans to enroll 49 participants.