Durvalumab Plus Chemotherapy in ES-SCLC (Oriental)

For inclusion in the study, patients should fulfill the following criteria:

• Male or female ≥18 years at the time of Screening.
• Written informed consent obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations.
• Histologically or cytologically documented extensive stage SCLC (stage IV [T any, N any, M1 a/b], or with T3-4 due to multiple lung nodules that are too extensive or have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan, according to American Joint Committee on Cancer Stage 8th edition).
• Brain metastases; must be asymptomatic or treated and stable off steroids and anti-convulsants for at least 1 month prior to study treatment. Patients with suspected brain metastases at screening should have a CT/MRI of the brain prior to study entry.
• Patients must be considered suitable to receive a platinum-based chemotherapy regimen as 1st line treatment for the ES-SCLC. Chemotherapy must contain either cisplatin or carboplatin in combination with etoposide.
• Life expectancy ≥12 weeks at Day 1.
• World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2 at enrollment.
• Note: Patients with PS2 will be limited to a maximum of 20% of the total study population; once this limit is met, additional enrolled patients must have PS 0-1.
• Body weight >30 kg.
• At least 1 lesion, not previously irradiated, that can be accurately measured at baseline as ≥10 mm in the longest diameter (except lymph nodes which must have a short axis ≥15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) and that is suitable for accurate repeated measurements as per RECIST 1.1 guidelines.
• Baseline CT/MRI results of the chest and abdomen (including liver and adrenal glands) within 28 days prior to the treatment initiation.
• No prior exposure to immune-mediated therapy including, but not limited to, other anti-CTLA-4, anti-PD-1, anti-PD-L1, and anti-programmed cell death ligand 2 (anti-PD-L2) antibodies, excluding therapeutic anticancer vaccines.
• Adequate organ and marrow function as defined below (test can be repeated once if necessary):
• Hemoglobin ≥9.0 g/dL.
• Absolute neutrophil count ≥1.5 × 10^9/L (use of granulocyte colony-stimulating factor is not permitted at within 7 days before testingscreening).
• Platelet count ≥100 × 10^9/L.
• Serum bilirubin ≤1.5 × the upper limit of normal (ULN).
• In patients without hepatic metastasis: ALT and AST ≤2.5 × ULN.
• In patients with hepatic metastases, ALT and AST ≤5 × ULN.
• Measured or calculated creatinine clearance: >60mL/min for patients planned to be treated with cisplatin and >40mL/min for patients planned to be treated with carboplatin
• Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause.

The following age-specific requirements apply:

• Women 1 year ago, had chemotherapy-induced menopause with last menses >1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).

Patients should not enter the study if any of the following exclusion criteria are fulfilled:

• Previous IP assignment in the present study.
• Medical contraindication to etoposide-platinum (carboplatin or cisplatin)-based chemotherapy.
• Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.
• Received prior systemic therapy for ES-SCLC. Patients who have received prior chemoradiotherapy for limited-stage SCLC must have been treated with curative intent and experienced a treatment-free interval of at least 6 months since last chemotherapy, radiotherapy, or chemoradiotherapy cycle fr