Extensive stage small cell lung cancer
Conditions
Interventions
Experimental group:Low-dose radiotherapy (LDRT) combined with duvalizumab (MEDI4736), etoposide and cisplatin/carboplatin
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. At the time of screening, the age of male or female subjects aged >=18 years old; 2. Obtain written informed consent and any locally required authorization from patients or their legal representatives prior to conducting any research protocol-related procedures, including screening assessments; 3. Histologically or cytologically confirmed extensive-stage disease (American Joint Committee on Cancer (8th edition) stage IV SCLC [any T, any N, and M1a/b/c]), or due to extensive pulmonary nodules or T3-4 disease in which the tumor/nodule is too large to be included in a tolerable radiotherapy plan; 4. Patients must be considered eligible to receive platinum-based chemotherapy regimens as first-line treatment for extensive-stage small cell lung cancer. Chemotherapy must include one of cisplatin or carboplatin, in combination with etoposide; 5. Patients must be considered suitable for thoracic radiotherapy as first-line treatment for extensive-stage small cell lung cancer; 6. Life expectancy on day 1 of study treatment >= 12 weeks; 7. The World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) physical status score was 0 or 1 at the time of enrollment; 8. Weight > 30 kg; 9. According to the requirements of RECIST1.1 guidelines, at least 1 lesion (without prior radiotherapy), the longest diameter of which is >=10mm (except for lymph nodes) is accurately measured by computed tomography (CT) or magnetic resonance imaging (MRI) at baseline. Its short axis must be >=15 mm); and the lesion is suitable for repeated and accurate measurement; 10. No previous exposure to immune-mediated therapy, including but not limited to other anti-PD-1, anti-PD-L1 and anti-programmed death ligand 2 (anti-PD-L2) antibodies, except for therapeutic anti-tumor vaccines; 11. Have sufficient organ and bone marrow function, which needs to be measured 28 days before receiving treatment, defined as follows: (1) Hemoglobin >=9 g/dL; (2) Absolute neutrophil count >=1.5 x 10^9/L (granulocyte colony-stimulating factor is not allowed during screening); (3) Platelet count >=75 x10^9/L; (4) Serum bilirubin 60mL/min, patients receiving carboplatin treatment > 45mL/min; 13. Evidence of postmenopausal status in female patients or negative urine or serum pregnancy test results in premenopausal female patients. Women are considered menopausal when they stop for 12 months without other medical reasons.
Exclusion criteria
Exclusion criteria: 1. Participate in the design and conduct of the study (for investigators and/or members of the research center); 2. Previously received the distribution of the investigational drug (IP) in this study; 3. Concurrently enrolled in another clinical study, unless it is an observational (non-interventional) clinical study or a follow-up phase of an interventional study; 4. Medical contraindications to etoposide-platinum (carboplatin or cisplatin)-based chemotherapy; 5. History of thoracic radiotherapy before systemic therapy or planning to undergo intensive thoracic radiotherapy. Radiation therapy outside the chest (eg, bone metastases) for palliative care is permitted, but must be completed prior to the first dose of study drug; 6. Concurrent use of any chemotherapy, biological or hormone therapy for cancer treatment. The use of hormone therapy for non-cancer-related conditions (eg, hormone replacement therapy) is acceptable; 7. Major surgery (as defined by the investigator) within 28 days prior to the first dose of IP. Note: Local surgery for isolated lesions for palliative care is acceptable; 8. History of allogeneic organ transplantation; 9. Paraneoplastic syndrome (PNS) of autoimmune nature requiring systemic treatment (systemic steroids or immunosuppressive agents) or clinical symptoms suggesting aggravation of PNS; 10. Active or previously documented autoimmune disease or inflammatory disease (including inflammatory bowel disease [eg, colitis or Crohn's disease], diverticulitis [other than diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, Wegener syndrome [granulomatous vasculitis, Graves' disease, rheumatoid arthritis, hypophysitis and uveitis, etc.]); 11. Uncontrolled concurrent diseases, including but not limited to: persistent or active infection, interstitial lung disease, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina, arrhythmia, associated Severe chronic gastrointestinal disease with diarrhea, or a psychiatric/social condition that may limit compliance with study requirements, cause a significantly increased risk of AEs, or interfere with the subject's ability to provide written informed consent; 12. History of primary malignant tumor; 13. History of leptomeningeal carcinoma; 14. History of active primary immunodeficiency; 15. Active infection, including tuberculosis (clinical assessment, including clinical history, physical examination, imaging findings, and tuberculosis testing consistent with local clinical practice), hepatitis B (known to be positive for HBV surface antigen [HbsAg]), hepatitis C, or human immunization Defective virus (positive for HIV 1/2 antibodies). Patients with previous HBV infection or who had been cured (defined as the presence of hepatitis B core IgG antibodies and the absence of HBsAg) were eligible. Patients who are positive for hepatitis C virus (HCV) antibodies are only eligible if they are negative for HCV RNA polymerase chain reaction; 16. Immunosuppressive drugs were used at the time of the first administration of durvalumab and olaparib or within 14 days before the first administration; 17. Administer live attenuated vaccine within 30 days before the first dose of IP. Note: After enrollment, patients cannot receive live vaccines during IP treatment and within 30 days after the last dose of IP; 18. Pregnant or lactating female patients, or male or female patients with reproductive potential who are unwilling to take effecti
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Median progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Median overall survival;Objective response rate;6-month progression-free survival;adverse event;blood pressure; | — |
Countries
China
Contacts
Public ContactLu You
West China Hospital of Sichuan University
Outcome results
None listed