A Phase II Trial to Evaluate the Efficiency and Safety of Serplulimab Plus Chemotherapy as Conversion Therapy in NSCLC
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorZhejiang University
About this trial
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
This trial does not accept healthy volunteersQualifiers
Patients should voluntarily join this study and sign the informed consent form
NSCLC patients diagnosed by cytology or histology and not previously receiving anti-tumor treatments (including systemic treatments, local treatments .etc)
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)
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)
Disqualifiers
NSCLC patients have sensitive EGFR mutation, EML4-ALK fusion or other forms of ALK gene changes
Patients have previously received immune checkpoint inhibitors such as PD-1/ PD-L1/CTLA4 antibody
Patients with other primary malignancies within the past 3 years (excluding cured skin basal cell carcinoma and cervical carcinoma in situ)
Patients with active hepatitis B/C
Trial design
Design model
Single group
Treatments tested in this trial
serplulimab plus chemotherapy as conversion treatment
Procedure/SurgeryPatients with unresectable NSCLC will receive serplulimab plus chemotherapy as conversion treatment, and then curative pneumonectomy will be provided for patients who are suitable for primary tumor resection. Locoregional ablative treatments will be performed for metastatic lesions.
Treatment groups
49 Participants
are divided into 1 treatment groupGroup A: Serplulimab plus chemotherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
the rate of NSCLC converting to resectable tumors
the proportion of unresectable NSCLC patients who are converted to being suitable for radical pneumonectomy after 3-4 cycles serplulimab plus chemotherapy
Time frame
up to 16 weeks2
the 1-year progression-free survival (PFS) rate
the proportion of patients who are progression-free after pneumonectomy
Time frame
up to one yearSecondary outcomes
1
the rate of R0 resection
the proportion of R0 resection in patients who receive pneumonectomy
Time frame
immediately after the surgery2
Progression-free survival (PFS)
The duration from the date of initial treatment to the date of disease progression or death due to any cause
Time frame
up to five years3
Overall survival (OS)
The duration from the date of initial treatment to the date of death due to any cause
Time frame
up to five years4
the rate of major pathological response (MPR)
the proportion of patients who achieve MRP among those receiving pneumonectomy
Time frame
up to 16 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov