The Study of Envafolimab Combined With Concurrent Chemoradiotherapy In LS-SCLC

Study Overview
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Brief Summary
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To evaluate the efficacy and safety of envafolimab combined with concurrent chemoradiotherapy in limited stage small cell lung cancer.

Detailed Description
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Envafolimab is the world's first subcutaneous injection of PD-L1 monoclonal antibody. Suitable for adult patients with advanced solid tumors with unresectable or metastatic microsatellite highly unstable (MSI-H) or mismatch repair gene defects (dMMR).

Official Title
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A Prospective, Two Cohort, Multicenter Phase II Clinical Study of Envafolimab Combined With Concurrent Chemoradiotherapy and Immune Maintenance Therapy For Limited Stage Small Cell Lung Cancer

Conditions
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Lung Neoplasms

Intervention / Treatment
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* Drug: Envafolimab combined with concurrent chemoradiotherapy (Hypofractionated radiotherapy)
* Drug: Envafolimab combined with concurrent chemoradiotherapy (Conventional Radiotherapy)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The result of histopathological or cytological diagnosis is small cell lung cancer. Diagnosed as limited stage by imaging examination (lesion limited to half chest and one radiotherapy field, without malignant pleural or pericardial effusion); And at least one measurable lesion that meets the RECIST 1.1 standard. Have not received systematic treatment in the past, and initially underwent 2 cycles of etoposide+cisplatin/carboplatin induction therapy. Age 18-75 years old, male or non pregnant female. The expected survival period is>3 months. ECOG score 0-1. Weight>30 kilograms. All patients underwent chest CT, head MRI, abdominal CT or MRI, and whole body bone scan before treatment to clarify. Hematological indicators: white blood cell (WBC) count ≥ 4 * 109/L, absolute neutrophil count (ANC) ≥ 1.5 * 109/L, hemoglobin (Hb) level>100 g/L, platelet (Plt) count>100 * 109/L, serum creatinine (Cr) level<1.5 times the upper limit of normal value, serum alanine transaminase (AST) and glutamic transaminase (ALT) levels<2.5 times the upper limit of normal value, and serum bilirubin level ≤ 1.5 times the upper limit of normal value. The patient has signed an informed notice and is willing and able to comply with the visit, treatment plan, laboratory examination, and other research procedures of the research plan. Exclusion Criteria: Patients with non-small cell lung cancer or mixed components of small cell lung cancer in histopathology. Patients with extensive stage small cell lung cancer (ES-SCLC). Merge malignant pleural effusion and pericardial effusion. Pregnant and lactating women. Merge patients with more severe underlying diseases. Patients who have previously been treated with inhibitors of immune regulatory points (CTLA-4, PD-1, PD-L1, etc.). Patients may require long-term use of immunosuppressive drugs or systemic or local use of corticosteroids with immunosuppressive doses for comorbidities. Patients with immunodeficiency disorders and a history of organ transplantation (including but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, nephritis, hyperthyroidism, hypothyroidism; vitiligo or childhood asthma. Patients who have completely relieved and do not require any intervention after adulthood can be included; asthma that requires medical intervention with bronchodilators cannot be included). Those whose laboratory test values during the screening period before enrollment do not meet relevant standards. Patients with significantly reduced heart, liver, lung, kidney, and bone marrow function. Serious and uncontrolled internal diseases and infections. Simultaneously using other investigational drugs or in other clinical trials. Refusal or inability to sign informed consent form for participation in the experiment. A history of allergies to etoposide, cisplatin, or any excipients. Researchers have determined that patients are not suitable to participate in the study and are unlikely to comply with the study procedures, limitations, and requirements.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypofractionated radiotherapy group<br>Envafolimab: 300mg SC d1,Q3W,2 cycles Cisplatin/carboplatin: Cisplatin: 75 mg/m2 IV d1,Q3W ,2 cycles or Carboplatin:AUC=5/6 IV d1,Q3W,2cycles Etoposide: 100mg/m2 IV d1,Q3W ,2 cycles Radiotherapy: Provide a prescription dose of 45Gy at a 95% PTV dose, with a single split dose of 3Gy, once a day, 5 times a week, for a total of 15 times. Envafolimab maintenance: 300mg,SC, d1. Q3W, up to 2 years or until PD or intolerable. | Drug: Envafolimab combined with concurrent chemoradiotherapy (Hypofractionated radiotherapy)<br>* Envafolimab: 300mg SC d1,Q3W,2 cycles Cisplatin/carboplatin: Cisplatin: 75 mg/m2 IV d1,Q3W ,2 cycles or Carboplatin:AUC=5/6 IV d1,Q3W,2cycles Etoposide: 100mg/m2 IV d1,Q3W ,2 cycles Radiotherapy: Provide a prescription dose of 45Gy at a 95% PTV dose, with a single split dose of 3Gy, once a day, 5 times a week, for a total of 15 times. Envafolimab maintenance: 300mg,SC, d1. Q3W, up to 2 years or until PD or intolerable.<br>* Other names: Hypofractionated Radiotherapy Group;|
| Experimental: Conventional Radiotherapy<br>Envafolimab: 300mg SC d1,Q3W,2 cycles Cisplatin/carboplatin:Cisplatin:75 mg/m2 IV d1,Q3W ,2 cycles or Carboplatin:AUC=5/6 IV d1,Q3W,2cycles Etoposide: 100mg/m2 IV d1,Q3W ,2 cycles Radiotherapy: Provide a prescription dose of 60Gy at a 95% PTV dose, with a single split dose of 2Gy, once per day, 5 times per week, for a total of 30 times Envafolimab maintenance: 300mg,SC, d1. Q3W, up to 2 years or until PD or intolerable. | Drug: Envafolimab combined with concurrent chemoradiotherapy (Conventional Radiotherapy)<br>* Envafolimab: 300mg SC d1,Q3W,2 cycles Cisplatin/carboplatin:Cisplatin:75 mg/m2 IV d1,Q3W ,2 cycles or Carboplatin:AUC=5/6 IV d1,Q3W,2cycles Etoposide: 100mg/m2 IV d1,Q3W ,2 cycles Radiotherapy: Provide a prescription dose of 60Gy at a 95% PTV dose, with a single split dose of 2Gy, once per day, 5 times per week, for a total of 30 times. Envafolimab maintenance: 300mg,SC, d1. Q3W, up to 2 years or until PD or intolerable.<br>* Other names: Conventional Radiotherapy Group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2-year PFS rate | 2-yaer progression-free survival rate | From date of randomization until the date of first documented progression or date of death from any cause up to 24 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR | Objective Response Rate | From date of randomization until the date of first documented progression or date of death from any cause up to 24 months. | 
| DCR | Disease control rate | From date of randomization until the date of intolerance the toxicity or PD up to 24 months. | 
| DOR | Duration of response | From date of randomization until the date of intolerance the toxicity or PD up to 24 months. | 
| OS | Overall survival | From date of randomization until the date of death(up to 24 months) | 
| Adverse event rate Adverse event rate Adverse event rate | Number of participants with adverse events as a measure of safety and tolerability | From date of randomization until the date of toxicity or PD (up to 24 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Envafolimab/SCLC/Chemoradiotherapy