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

  • STATUS
    Recruiting
  • End date
    Jan 31, 2025
  • participants needed
    360
  • sponsor
    AstraZeneca
Updated on 25 November 2020
Investigator
AstraZeneca Clinical Study Information Center
Primary Contact
Research Site (2.0 mi away) Contact
+144 other location
chemoradiotherapy
durvalumab
lung carcinoma

Summary

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.

Description

Approximately 360 patients will be randomized in a 2:1 to receive treatment with durvalumab or placebo therapy. EGFR or ALK mutation randomised will be capped at approximately 15%. The primary objective of this study is to assess the efficacy of durvalumab treatment compared with placebo in terms of PFS(according to Blinded Independent Central Review).

Details
Treatment Placebo, durvalumab
Clinical Study IdentifierNCT03706690
SponsorAstraZeneca
Last Modified on25 November 2020

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Eligibility

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Inclusion Criteria

Is your age between 18 yrs and 130 yrs?
Gender: Male or Female
Do you have Non-Small Cell Lung Cancer?
Do you have any of these conditions: Do you have Non-Small Cell Lung Cancer??
Age18 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
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
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