Small cell lung cancer
Conditions
Interventions
experimental group:Durvalumab in combination with platinum-based chemotherapy followed by chest radiotherapy
Sponsors
Jiangsu Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged 18-65 years and no gender limit. 2. Obtain written informed consent from the patient or his legal representative before carrying out any research program related procedures (including screening evaluation). 3. Histological or cytological syndrome of small cell lung cancer, imaging evaluation staging is extensive. 4. Provide archived tumor tissue blocks of existing samples (or at least 10 newly cut unstained sections). 5. Patients are suitable for platinum-based chemotherapy as the first-line treatment of ED-SCLC. Chemotherapy must include either cisplatin or carboplatin, combined with etoposide. 6. Life expectancy >= 12 weeks. 7. At the time of selection, the World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) physical status score was 0 or 1. 8. Weight > 45 kg. 9. According to the requirements of RECIST 1.1 guidelines, at least one measurable lesion after chemotherapy should be accurately measured by computed tomography (CT) or magnetic resonance imaging (MRI) at baseline, and the lesion is suitable for repeated and accurate measurement. 10. Have sufficient organ and bone marrow functions, defined as follows: (1) Hemoglobin >=9.0 g/dL. (2) Absolute neutrophil count >= 1.5 x 10^9/L (granulocyte colony stimulating factor is not allowed during screening). (3) Platelet count >=100 x 10^9/L. (4) Serum bilirubin 60mL/min, and patients receiving carboplatin treatment >45mL/min: Male: Creatinine CL (mL/min) = weight (kg) x (140-age) 72 x serum creatinine (mg/dL) Female: Creatinine CL (mL/min) = weight (kg) x (140-age) x 0.85 72 x serum creatinine (mg/dL). 11. The female patient has evidence of postmenopausal status, or the urine or serum pregnancy test result of the premenopausal female patient is negative. Women who stop menopause for 12 months without other medical reasons are considered menopausal. The specific requirements for age are as follows: (1) For female patients =50 years of age, if the menopause is 12 months or more after stopping all exogenous hormone treatments, or if they have undergone surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy), it can be regarded as a postmenopausal woman.
Exclusion criteria
Exclusion criteria: 1. Have received radiotherapy and chemotherapy in the past. 2. Enrolled in another clinical study at the same time. 3. There is a medical contraindication to etoposide-platinum (carboplatin or cisplatin)-based chemotherapy. 4. It has medical contraindications to chest radiotherapy. 5. Major surgery (defined by the investigator) within 28 days before the first dose. Note: For the purpose of palliative care, local surgery on isolated lesions is acceptable. 6. History of allogeneic organ transplantation. 7. Paraneoplastic syndromes (PNS) of autoimmune nature requiring systemic treatment (systemic steroids or immunosuppressive agents) or clinical symptoms suggesting exacerbation of PNS. 8. Active or previously recorded autoimmune diseases or inflammatory diseases (including inflammatory bowel disease (such as colitis or Crohn's disease), diverticulitis (except diverticulosis), systemic lupus erythematosus, Sarcoidosis syndrome, Wegener syndrome (granulomatous vasculitis, Graves disease, rheumatoid arthritis, hypophysitis, uveitis, etc.). For this standard, the following exceptions: (1) Patients with vitiligo or alopecia; (2) Patients with hypothyroidism (for example, after Hashimoto syndrome) and stable disease after receiving hormone replacement therapy; (3) Any chronic skin disease that does not require systemic treatment; (4) Patients without active disease in the past 3 years can be included in the study after discussing with the research physician; (5) Patients with celiac disease who can be controlled by diet alone. 9. Uncontrolled concurrent diseases, including but not limited to: persistent or active infection, interstitial lung disease, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina, arrhythmia, severe chronic gastrointestinal disease with diarrhea, or may limit compliance with research requirements, psychiatric/social problem conditions that cause a significant increase in the risk of AEs or affect the Patients ability to provide written informed consent. 10. History of another primary malignant tumor, except for the following conditions: (1) Treated for the purpose of curing, malignant tumors with no known active disease >=5 years before the first administration and with low potential recurrence risk; (2) Adequately treated non-melanoma skin cancer or malignant freckle-like moles without evidence of disease; (3) Carcinoma in situ with adequate treatment and no evidence of disease. 11. History of leptomeningeal carcinoma. 12. History of active primary immunodeficiency. 13. Active infections, including tuberculosis, hepatitis B, hepatitis C or human immunodeficiency virus. Patients who have previously had HBV infection or have been cured (defined as the presence of hepatitis B core IgG antibodies and the absence of HBsAg) are eligible. Patients who are positive for HCV antibodies are only eligible if they are negative for HCV RNA polymerase chain reaction. 14. Within 14 days before the first administration of Durvalumab, are or have been using immunosuppressive drugs. For this standard, the following exceptions: (1) Intranasal, inhaled, topical steroid therapy or local injection of steroid drugs (such as intra-articular injection); (2) Systemic corticosteroid therapy that does not exceed 10 mg/day prednisone or its equivalent physiological dose; (3) Use steroid drugs for the prevention of allergic reactions (such as medication before CT scan). It can accept steroid pre-treat
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival;Safety; | — |
Countries
China
Contacts
Public ContactZhu Xiangzhi
Jiangsu Cancer Hospital
Outcome results
None listed