Phase III Study to Determine the Efficacy of Durvalumab in Combination With Chemotherapy in Completely Resected Stage II-III Non-small Cell Lung Cancer (NSCLC)

  • STATUS
    Recruiting
  • End date
    Sep 30, 2026
  • participants needed
    332
  • sponsor
    AstraZeneca
Updated on 25 July 2021
Investigator
AstraZeneca Clinical Study Information Center
Primary Contact
Research Site (1.2 mi away) Contact
+245 other location
durvalumab
cancer chemotherapy
lung carcinoma

Summary

This is a Phase III, randomized, parallel-arm, placebo controlled, double blind, multicenter study assessing the efficacy and safety of durvalumab versus placebo following SoC chemotherapy in patients with completely resected stage II-III NSCLC who are MRD+ post surgery

Description

Patients who have no evidence of disease recurrence confirmed by CT and/or MRI and are confirmed to meet all eligibility criteria will be randomized 1:1 to durvalumab + Standard of care (SoC) chemotherapy or placebo + Standard of care (SoC) chemotherapy arm.

The primary objective of this study is to assess the efficacy of durvalumab +SoC chemotherapy compared to placebo+ SoC chemotherapy in terms of DFS measured in MRD+ patients.

Details
Condition Non-Small Cell Lung Cancer
Treatment Durvalumab + SoC chemotherapy, Placebo + SoC chemotherapy
Clinical Study IdentifierNCT04385368
SponsorAstraZeneca
Last Modified on25 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Capable of giving signed informed consent, which includes a mandatory genetic informed consent and compliance with the requirements and restrictions listed in the informed consent forms (ICFs) and study protocol
Age 18 years at the time of screening
Diagnosis of histologically confirmed NSCLC (WHO 2015 classification) with resectable (stage II-III) disease
Complete resection of the primary NSCLC

Exclusion Criteria

Postoperative imaging demonstrating unequivocal evidence of disease recurrence or tissue biopsy-proven disease recurrence
EGFR-mutant and/or ALK-translocation
Mixed small cell and NSCLC histology
Received any prior adjuvant therapy for NSCLC or any prior exposure to durvalumab
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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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