癌研連線CancerLink
Active, not recruiting NCT03706690

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

Non-Small Cell Lung CancerSarcomaPhase 3Stage IIIStage IVPD-L1

This is a Phase III, randomised, double-blind, placebo-controlled, multicentre study assessing the efficacy and safety of durvalumab compared with placebo, as consolidation therapy in patients with locally advanced, unresectable, non-small cell lung cancer (Stage III), who have not progressed following definitive, platinum-based, chemoradiation therapy.

Conditions: Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • History of allogeneic organ transplantation, or another primary malignancy, or active primary immunodeficiency.
  • Active or prior documented autoimmune or inflammatory disorders
  • 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).
  • Mixed small cell and NSCLC histology, sarcomatoid variant
  • 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.

Eligibility criteria are kept as the original English records from ClinicalTrials.gov; actual eligibility is determined by the research team's formal assessment and the informed consent form. Source: ClinicalTrials.gov, updated automatically every two weeks. Last synced: 2026年10月8日.