This trial aims to assess efficacy and safety of durvalumab combined with chemoradiotherapy for limited stage small cell lung cancer.
Voluntary participation and written signed informed consent;
Age 18-75 years old, gender is not limited;
Histologically or cytologically confirmed limited-stage small cell lung cancer (2009 AJCC/UICC/IASLC lung cancer TNM staging criteria, limited-stage SCLC is any T stage, any N stage, and M0), and patients with suspected brain or bone metastasis at the time of screening should undergo brain MRI or ECT before study enrollment;
There are immunohistochemical results;
Distant organ metastases (excluding supraclavicular lymph nodes) as determined by CT evaluation during screening and prior imaging;
have received prior radiotherapy to the chest;
have medical contraindications to etoposide - platinum (carboplatin or cisplatin) based chemotherapy;
having any active autoimmune disease or a history of autoimmune disease (e.g. interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary gland inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (which can be included if hormone replacement therapy is effective), etc.), and a history of immunosuppressive drug use within 28 days, with the exception of the use of hormones for the purpose of dealing with toxicity from radiotherapy;
Single group
Durvalumab
DrugDurvalumab is an immunoglobulin G (IgG) 1-κsubtype monoclonal antibody (mAb) that blocks the interaction of PD-L1 with PD-1 in T cells and CD80 (B7.1) in immune cells (ics). Durvalumab is developed by Astrazeneca /MedImmune for the treatment of cancer. Durvalumab is designed to reduce the cytotoxicity of antibody-dependent cells and complement dependent cytotoxicity. In vitro studies have demonstrated that Durvalumab can antagonize the inhibition of PD-L1 in human primary T cells, causing them to resume proliferation and release interferon gamma (IFNγ). To date, more than 1,800 patients have been treated with valiuzumab as a single agent or in combination with other cancer agents as part of ongoing studies. Durvalumab: 10mg/Kg, intravenously, starting at week 7 every 3 weeks for at least 1 year, or until progression, intolerance, or spontaneous withdrawal of the patient.
Chemotherapy drug of EP regimen
DrugEtoposide: 80-100mg/m², intravenous infusion, given at week 1, 4, 7, 10, 13, 16, a total of 6 cycles. Carboplatin: AUC=5-6, intravenous infusion, given at weeks 1, 4, 7, 10, 13, 16, a total of 6 weeks. Or cisplatin: 75-80mg/m2 intravenously, given at weeks 1, 4, 7, 10, 13, 16 for a total of 6 weeks.
radiotherapy
RadiationRadiotherapy: Total dose of 60Gy/30 times, each time 2.0Gy, 5 times a week from week 7 to week 12 of radiotherapy.
Assessment of objective remission rate (ORR) in limited stage small cell lung cancer treated with durvalumab combined with chemoradiotherapy
Objective tumor remission is assessed by the investigator using the Solid Tumor Remission Assessment Criteria (RECIST 1.1 criteria). Objective remission rate (ORR): defined as the proportion of subjects whose tumor volume shrinks to a pre-specified value and can be maintained for the minimum time frame required, incorporating cases in complete remission (CR) and partial remission (PR).
Assessment of the incidence of treatment-related adverse events Incidence of Treatment-Emergent Adverse Events.
Adverse events are observed during the course of the study and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE V5.0).
Assessment of overall survival (OS) in limited stage small cell lung cancer.
Objective tumor remission is assessed by the investigator using the Solid Tumor Remission Assessment Criteria (RECIST 1.1 criteria). OS is defined as the time from the start of enrollment to death from any cause.
Assessment of progression-free survival (PFS) in limited stage small cell lung cancer.
Objective tumor remission is assessed by the investigator using the Solid Tumor Remission Assessment Criteria (RECIST 1.1 criteria). PFS is defined as the time from the start of enrollment until tumor progression or death from any cause.
Assessment of disease control rate (DCR) in limited stage small cell lung cancer.
Objective tumor remission is assessed by the investigator using the Solid Tumor Remission Assessment Criteria (RECIST 1.1 criteria). Disease control rate (DCR): the proportion of patients whose tumors shrank or were stable and remained so for a certain period of time, including complete remission (CR), partial remission (PR) and stable disease (SD).
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