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

NCT04642469 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-06-25

Study results available
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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.

Conditions

  • Carcinoma, Non- Small Cell Lung

Interventions

DRUG

Durvalumab

Intravenous administration of Durvalumab

OTHER

Placebo

Placebo Comparator

Sponsors & Collaborators

Principal Investigators

  • David Spigel · SCRI Development Innovations, LLC

  • Charles Swanton · Francis Crick Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-30
Primary Completion
2023-05-31
Completion
2024-01-15
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Canada
  • Czechia
  • France
  • Greece
  • Hong Kong
  • Hungary
  • India
  • Israel
  • Italy
  • Japan
  • Netherlands
  • Peru
  • Poland
  • Russia
  • Singapore
  • South Korea
  • Spain
  • Taiwan
  • Turkey (Türkiye)
  • Vietnam

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04642469 on ClinicalTrials.gov