Durvalumab Plus Chemotherapy in ES-SCLC (Oriental)

  • End date
    Dec 30, 2022
  • participants needed
  • sponsor
Updated on 22 August 2021


This will be an open-label, single-arm, multicenter, Phase IIIb study to determine the safety of durvalumab + etoposide and cisplatin or carboplatin as first-line treatment in patients with extensive stage small-cell lung cancer.

Condition Small Cell Lung Carcinoma Extensive Disease
Treatment Durvalumab plus chemotherapy
Clinical Study IdentifierNCT04449861
Last Modified on22 August 2021


Yes No Not Sure

Inclusion 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)
1 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
1Note: 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
\. 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
1 Hemoglobin 9.0 g/dL. 10.2 Absolute neutrophil count 1.5 10^9/L (use of
granulocyte colony-stimulating factor is not permitted at screening)
3 Platelet count 100 10^9/L. 10.4 Serum bilirubin 1.5 the upper limit of
normal (ULN). 10.5 In patients without hepatic metastasis: ALT and AST 2.5
ULN. 10.6 In patients with hepatic metastases, ALT and AST 5 ULN. 10.7
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

Exclusion Criteria

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
Any condition that, in the opinion of the treating physician, would interfere with evaluation of the study drug or interpretation of patient safety
Planned consolidation chest radiation therapy. Radiation therapy outside of the chest for palliative care (ie, bone metastasis) is allowed but must be completed before first dose of the study medication
Major surgical procedure (as defined by the investigator) within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable
History of allogeneic organ transplantation
Has a paraneoplastic syndrome (PNS) of autoimmune nature, requiring systemic treatment (systemic steroids or immunosuppressive agents) or has a clinical symptomatology suggesting worsening of PNS
Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn's disease], diverticulitis with the exception of diverticulosis, systemic lupus erythematosus, sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, and uveitis, etc]). The following are exceptions to this
Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, active interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent
History of active primary immunodeficiency
Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice), hepatitis B (known positive HBV surface antigen [HbsAg] result), hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HbsAg) are eligible. Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA
Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion
Receipt of live, attenuated vaccine within 30 days prior to the first dose of IP. Note: Patients, if enrolled, should not receive live vaccine whilst receiving IP and up to 30 days after the last dose of IP
Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from Screening to 90 days after the last dose of durvalumab
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