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

  • End date
    Mar 4, 2025
  • participants needed
  • sponsor
Updated on 15 November 2021
lung carcinoma


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.


Approximately 400 patients will be randomized in a 2:1 to receive treatment with durvalumab or placebo therapy. The primary objective of this study is to assess the efficacy of durvalumab treatment compared with placebo in terms of PFS.

Condition Non-Small Cell Lung Cancer
Treatment Placebo, durvalumab
Clinical Study IdentifierNCT03706690
Last Modified on15 November 2021


Yes No Not Sure

Inclusion Criteria

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, 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
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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