This trial aims to assess efficacy and safety of durvalumab combined with chemoradiotherapy for limited stage small cell lung cancer.
Small cell lung cancer is a highly malignant tumor that accounts for about 15% of all lung cancer types. The 5-year survival rate is less than 5%, and the overall survival of patients who do not receive any antitumor therapy is only 2-4 months. In the past 40 years, 4 to 6 cycles of platinum-based chemotherapy, that is, etoposide combined with cisplatin or carboplatin, has become the standard therapy for small cell lung cancer patients and has been recommended by major global tumor treatment guidelines. While initial response rates are as high as 70%, 80% of limited-stage patients and nearly all patients with extensive stages are found to experience relapse or disease progression. Current guidelines recommend that patients with limited stage small cell lung cancer adopt the EP regimen combined with thoracic radiotherapy as the preferred treatment for patients with limited stage small cell lung cancer. PD-L1 is part of a complex system of receptors and ligands involved in controlling T cell activation. PD-L1 acts at multiple sites in the body, releasing inhibitory signals to T cells via the PD-1 and CD80 receptors to help regulate the immune response. Durvalumab 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). This trial aims to assess efficacy and safety of durvalumab combined with chemoradiotherapy for limited stage small cell lung cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
58
Durvalumab 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.
Etoposide: 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.
Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
RECRUITINGAssessment 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).
Time frame: Treatment with durvalumab for at least 1 year, or until progression, intolerance, or spontaneous withdrawal of patients.
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).
Time frame: Treatment with durvalumab for at least 1 year, or until progression, intolerance, or spontaneous withdrawal of patients.
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.
Time frame: Treatment with durvalumab for at least 1 year, or until progression, intolerance, or spontaneous withdrawal of patients.
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.
Time frame: Treatment with durvalumab for at least 1 year, or until progression, intolerance, or spontaneous withdrawal of patients.
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Radiotherapy: Total dose of 60Gy/30 times, each time 2.0Gy, 5 times a week from week 7 to week 12 of radiotherapy.
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).
Time frame: Treatment with durvalumab for at least 1 year, or until progression, intolerance, or spontaneous withdrawal of patients.