Phase III Study to Determine Efficacy of Durvalumab in Stage II-III Non-small Cell Lung Cancer (NSCLC) After Curative Intent Therapy.

  • STATUS
    Recruiting
  • End date
    Oct 29, 2027
  • participants needed
    284
  • sponsor
    AstraZeneca
Updated on 19 September 2021
Investigator
AstraZeneca Clinical Study Information Center
Primary Contact
Research Site (2.4 mi away) Contact
+196 other location
durvalumab
lung carcinoma

Summary

This is a Phase III double-blind, placebo-controlled study of Durvalumab versus Placebo in patients with stage II-III NSCLC who are MRD-positive following curative intent therapy.

Description

This is a Phase III, randomized, multicenter, double-blind, placebo-controlled, study to evaluate the efficacy and safety of durvalumab adjuvant therapy compared to placebo in patients with completely resected stage II-III NSCLC who have undergone curative intent therapy (complete resection neoadjuvant and/or adjuvant therapy), who have no evidence of Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1-defined disease recurrence, and who become MRD+ during a 96-week surveillance period.

Details
Condition Non-Small Cell Lung Cancer
Treatment Placebo, durvalumab
Clinical Study IdentifierNCT04642469
SponsorAstraZeneca
Last Modified on19 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICFs and in the protocol
Age 18 years at the time of screening (ICF1)
Histologically confirmed NSCLC with resectable stage II-III disease
Complete resection of the primary NSCLC

Exclusion Criteria

EGFR and/or ALK mutant
Mixed small cell and NSCLC histology
History of allogeneic organ or bone marrow transplantation
History of active primary immunodeficiency
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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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