A Randomized Controlled, Multicenter Phase II Study to Evaluate the Efficacy and Safety of Combination Therapy With Serplulimab and RT in Patients With ES-SCLC Who Have Not Progressed After Treat With Serplulimab Combined Chemotherapy

Zhejiang Cancer Hospital1 site in 1 country100 target enrollmentOctober 18, 2023

ConditionsExtensive Stage Lung Small Cell Cancer

InterventionsSerplulimab Chest Radiation

DrugsSerplulimab

Overview

Phase: Phase 2
Intervention: Serplulimab
Conditions: Extensive Stage Lung Small Cell Cancer
Sponsor: Zhejiang Cancer Hospital
Enrollment: 100
Locations: 1
Primary Endpoint: 1-year Progression-free survival rate
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Detailed Description

This phase II trial compares the effect of adding radiation therapy to the usual maintenance therapy with Serplulimab versus Serplulimab alone in patients who have already received Serplulimab plus chemotherapy for the treatment of extensive stage small cell lung cancer . Immunotherapy with monoclonal antibodies, such as Serplulimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving radiation therapy in addition to Serplulimab may extend the time without extensive small cell lung cancer growing or spreading compared to Serplulimab alone.

Registry

clinicaltrials.gov

Start Date

October 18, 2023

End Date

December 31, 2025

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Zhejiang Cancer Hospital

Responsible Party

Principal Investigator

Fan Yun, MD

Head of Chest Oncology Department

Zhejiang Cancer Hospital

Eligibility Criteria

Inclusion Criteria

•Voluntary participation in clinical studies; fully understand, be informed about the study and have signed the informed consent form (ICF).
•Male or female aged ≥ 18 and ≤ 75 years, at the time of signing the ICF.
•Willingness to follow and ability to complete all trial procedures.
•Histologically or cytologically diagnosed with ES-SCLC (according to the Veterans Administration Lung Study Group staging system).
•No prior systemic therapy for ES-SCLC；at the end of the combination chemotherapy with serplulimab, the efficacy evaluation is CR, PR, or SD.
•At least one measurable lesion as assessed according to RECIST 1.1 , lesions that have received radiation therapy in the past are only considered measurable if they show clear progression.
•An ECOG PS score of 0 or
•An expected survival ≥ 3 months.
•Normal major organ functions
•For participants receiving therapeutic anticoagulation: stable anticoagulant regimen

Exclusion Criteria

•Complete response or tumor progression occurred during the combination of serplulimab and chemotherapy treatment.
•Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.Patients with CNS lesions treated and Asymptomatic are eligible to participate in this study if they meet all of the following criteria: Measurable lesions exist outside of CNS that meet the definition of RECISTv1.1; The patient has no history of Intracranial hemorrhage or intracerebral hemorrhage; The patient did not receive stereotactic radiotherapy within 7 days before the start of the study treatment, whole brain radiotherapy within 14 days before the start of the study treatment, or Neurosurgery resection within 28 days before the start of the study treatment; Patients do not need to continue to receive Corticosteroid treatment for CNS diseases. Allowing stable doses of anticonvulsant drugs for treatment; Transfer is limited to the cerebellum or supratentorial area (i.e. not transferred to the midbrain, pons, medulla oblongata, or spinal cord); There is no evidence to suggest progress between the completion of CNS local treatment and the initiation of study treatment; New Asymptomatic patients with central nervous system metastasis found during screening are eligible to participate in this study after receiving radiotherapy and/or surgery
•History of leptomeningeal disease.
•The total number of liver metastases was ≥3 or a single liver metastases was greater than 3cm
•Uncontrolled tumor-related pain
•Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.
•Uncontrolled or symptomatic hypercalcemia (\> 1.5 mmol/L ionized calcium or calcium \> 12 mg/dL or corrected serum calcium \> ULN).
•Known active or suspected autoimmune diseases. Subjects in a stable state with no need for systemic immunosuppressant therapy are allowed to enroll.
•Have a history of Idiopathic pulmonary fibrosis, organized pneumonia (such as Bronchiolitis obliterans), drug-induced pneumonia or idiopathic pneumonia, or chest computed tomography (CT) at screening shows evidence of active pneumonia.
•Active or latent pulmonary tuberculosis.

Arms & Interventions

Serplulimab+Radiation Therapy

Patients receive Serplulimab IV over 30 minutes +/- 10 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo radiation therapy QD on days 1-5 during weeks 1-3 only. Patients undergo PET/CT scan, CT, and MRI throughout the trial. Patients also undergo blood and tissue collection throughout the trial.

Intervention: Serplulimab

Serplulimab+Radiation Therapy

Intervention: Chest Radiation

Serplulimab

Patients receive Serplulimab IV over 30 minutes +/- 10 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo PET/CT scan, CT, and MRI throughout the trial. Patients also undergo blood and tissue collection throughout the trial.

Intervention: Serplulimab