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)
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- STATUS
- Recruiting
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- End date
- Sep 30, 2026
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- participants needed
- 332
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- sponsor
- AstraZeneca
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 Identifier | NCT04385368 |
| Sponsor | AstraZeneca |
| Last Modified on | 18 September 2021 |
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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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