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NCT04385368 · ClinicalTrials.gov registry record · Phase 3

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)

A Phase 3 study of Carcinoma, Non-Small Cell Lung, sponsored by AstraZeneca.

Completed
Registry status
Phase 3
Development phase
89
Enrollment target
20
Study locations

NCT04385368: Completed Phase 3 study of Carcinoma, Non-Small Cell Lung, sponsored by AstraZeneca.

NCT04385368 is a Phase 3 study of Carcinoma, Non-Small Cell Lung that has completed, run by AstraZeneca. The registered enrollment target is 89 participants, below the 323-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (72% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04385368, a Phase 3 study of Carcinoma, Non-Small Cell Lung, has completed, sponsored by AstraZeneca.

COMPLETED
Registry status
Phase 3
Development phase
89 participants
Enrollment target
20
Study locations

Study 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

Primary Outcome

DFS was defined as the time from the date of randomization until either of the following events, whichever occurred first: disease recurrence using Investigator RECIST 1.1 assessments (i.e., local or regional recurrence, distant recurrence, second primary NSCLC) or death from any cause.

Conditions Studied

Carcinoma, Non-Small Cell Lung

Interventions

  • DRUG Durvalumab + SoC chemotherapy
  • OTHER Placebo + SoC chemotherapy

Study Locations (20)

Other

  • Research Site - Rosario
  • Research Site - Camperdown
  • Research Site - St Leonards
  • Research Site - Aalst
  • Research Site - Brussels

California

  • Research Site - Long Beach
  • Research Site - Santa Rosa
  • Research Site - West Hollywood

Alabama

  • Research Site - Birmingham

Florida

  • Research Site - Miami

Maryland

  • Research Site - Silver Spring

Minnesota

  • Research Site - Minneapolis

Nebraska

  • Research Site - Lincoln

New Mexico

  • Research Site - Albuquerque

Trial Details

FieldValue
Enrollment Target 89 participants
Start Date 2020-07-17
Est. Completion 2023-08-31
Phase Phase 3
AstraZeneca

1,285 total trials

What the finished NCT04385368 record still lists

NCT04385368 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 89 participants, a relatively small participant target, below the 323-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (72% lower).

The record links to 1 condition, with Carcinoma, Non-Small Cell Lung appearing as the primary indexed condition, and to 2 interventions - of which Durvalumab + SoC chemotherapy is the first listed.

NCT04385368 names 20 study sites across 14 states, led by Other, California, Alabama.

Frequently Asked Questions

What is clinical trial NCT04385368 about?

NCT04385368 is a clinical study titled "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)". 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

What is the current status of trial NCT04385368?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 89 participants. The study started on 2020-07-17. Estimated completion is 2023-08-31.

What conditions does trial NCT04385368 study?

This clinical trial studies the following conditions: Carcinoma, Non-Small Cell Lung.

What interventions are being tested in trial NCT04385368?

The interventions under investigation include: Durvalumab + SoC chemotherapy (DRUG), Placebo + SoC chemotherapy (OTHER).

Who is sponsoring clinical trial NCT04385368?

This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04385368 being conducted?

This trial has 20 study locations across Alabama, California, Florida, Maryland, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Carcinoma, Non-Small Cell Lung

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04385368's enrollment target sits among peer trials

89 77th of 130 higher than 54 of 130 other Carcinoma, Non-Small Cell Lung trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Carcinoma, Non-Small Cell Lung trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT04385368, the US trial registry maintained by the National Library of Medicine. NCT04385368 (small enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.