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

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

NCT ID: NCT05904015

Condition: Lung Neoplasms

Conditions: Official terms:
Lung Neoplasms

Conditions: Keywords:
Envafolimab/SCLC/Chemoradiotherapy

Study type: Interventional

Study phase: Phase 2

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Envafolimab combined with concurrent chemoradiotherapy (Hypofractionated radiotherapy)
Description: 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.
Arm group label: Hypofractionated radiotherapy group

Other name: Hypofractionated Radiotherapy Group

Intervention type: Drug
Intervention name: Envafolimab combined with concurrent chemoradiotherapy (Conventional Radiotherapy)
Description: 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.
Arm group label: Conventional Radiotherapy

Other name: Conventional Radiotherapy Group

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

Detailed description: 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).

Criteria for eligibility:
Criteria:
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.

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Start date: August 1, 2023

Completion date: June 30, 2027

Lead sponsor:
Agency: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Agency class: Other

Source: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05904015