Lung Cancer Clinical Trials

Find Lung Cancer Clinical Trials Near You

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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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)

• Age from 18 to 75 years old, both male and female

• ECOG score 0-1

• According to the RECIST v1.1 , patients should have at least one measurable lesion

• 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

• According clinical evaluation, the lung function of patients (such as FVC, FEV1, TLC, FRC, DLco, etc.) should be sufficient for pneumonectomy

⁃ 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

⁃ 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

Locations
Other Locations
China
Zhejiang University
RECRUITING
Hangzhou
Contact Information
Primary
Peng Zhao, MD
zhaop@zju.edu.cn
+86-18767186629
Backup
Jian Hu, MD
dr_hujian@zju.edu.cn
+86-18767186629
Time Frame
Start Date: 2023-05-15
Estimated Completion Date: 2026-12-30
Participants
Target number of participants: 49
Treatments
Experimental: Serplulimab plus chemotherapy
Patients with unresectable NSCLC will receive 3-4 cycles of serplulimab plus chemotherapy as the conversion treatment (serplulimab 300mg d1 q3w; carboplatin (AUC 5) on day 1, and pemetrexed (500 mg/m2 for adenocar- cinoma) or nab-paclitaxel (260 mg/m2 for squamous carcinoma) d1 q3w), 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. Maintenance treatment with PD-1 antibody q3w will continue up to 12 months or disease progression after surgery.
Sponsors
Leads: Zhejiang University

This content was sourced from clinicaltrials.gov

Similar Clinical Trials

We couldn't find any related articles check for more on the main search page.