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A Study to Determine Safety of Durvalumab After Sequential Chemo Radiation in Patients With Unresectable Stage III Non-Small Cell Lung Cancer

NCT03693300 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 117

Last updated 2024-06-18

Study results available
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Summary

This is a Phase II, open-label, multi-centre study to determine the safety of a fixed dose of Durvalumab (MEDI4736) (1500 mg) every 4 weeks \[q4w\] in participants with unresectable Stage III Non-Small Cell Lung Cancer (NSCLC), who have not progressed following platinum-based sequential chemoradiation therapy (sCRT). This study will be conducted in Europe and North America.

Conditions

  • Non-small Cell Lung Cancer (NSCLC)

Interventions

DRUG

Durvalumab

Participants will receive 1500 mg Durvalumab monotherapy via IV infusion q4w for up to a maximum of 24 months with the last administration at Week 104.

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2019-04-16
Primary Completion
2022-12-13
Completion
2023-04-21
FDA Drug
Yes

Countries

  • United States
  • France
  • Germany
  • Italy
  • Spain
  • United Kingdom

Study Locations

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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 NCT03693300 on ClinicalTrials.gov