A Study of Durvalumab as Consolidation Therapy in Non-Small Cell Lung Cancer Patients

Korábbi kezelés

• Active or prior documented autoimmune or inflammatory disorders
• Any unresolved toxicity National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥2 from the prior chemoradiation therapy.
• Receipt of live attenuated vaccine within 30 days prior to the first dose of IP.
• Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP.

Más betegség

• History of allogeneic organ transplantation, or another primary malignancy, or active primary immunodeficiency.
• Uncontrolled intercurrent illness 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
• Active infection including tuberculosis hepatitis B hepatitis C (HCV), or human immunodeficiency virus (positive human immunodeficiency virus \[HIV\] 1/2 antibodies).

Egyéb

• Mixed small cell and NSCLC histology, sarcomatoid variant

• Age≥18 years
• Documented NSCLC and present with locally advanced, unresectable (Stage III) disease;
• Receipt of concurrent or sequential chemoradiation therapy,
• No progression following definitive, platinum-based, concurrent or sequential chemoradiation therapy
• World Health Organization (WHO) PS of 0 or 1;
• No prior exposure to any anti CTLA-4, anti-PD-1, anti-PD-L1, or anti PD L2 antibodies, excluding therapeutic anticancer vaccines
• Adequate organ and marrow function required
• Life expectancy of at least 12 weeks
• Tumor PD-L1 status, with the Ventana SP263 PD-L1 IHC assay determined by a reference laboratory, must be known prior to randomization.
• Tumour sample requirements are as follows: Provision of a tumour tissue sample (newly acquired sample \<=3 months old is preferred, but an archived sample \<=6 months old is acceptable) in a quantity sufficient to allow for analysis.