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

Part of paid clinical trials in Gainesville, Georgia.

Sponsor
AstraZeneca
Study ID
NCT03693300
Phase
PHASE2
Status
Completed

Conditions

  • Non-small Cell Lung Cancer (NSCLC)

Eligibility Criteria

Sex
ALL
Age
18 Years - 130 Years
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — DRUG
    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.

Study Details

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.

Key Dates

Start date
Apr 16, 2019
Status verified
May 2024
Primary completion
Dec 13, 2022
Completion
Apr 21, 2023

Study Design

Enrollment
117 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: WHO/ECOG PS 0 to 1 Cohort
    100-120 participants will receive 1500 mg Durvalumab (MEDI4736) monotherapy via IV infusion q4w for up to a maximum of 24 months (up to 26 doses/cycles) with the last administration at Week 104. The study drug should be discontinued prior to 24 months if there is clinical progression or confirmed radiological progression or if there is unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met.
  • Experimental: WHO/ECOG PS 2 Cohort
    up to 30 participants will receive 1500 mg Durvalumab (MEDI4736) monotherapy via IV infusion q4w for up to a maximum of 24 months (up to 26 doses/cycles) with the last administration at Week 104. The study drug should be discontinued prior to 24 months if there is clinical progression or confirmed radiological progression or if there is unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met.

Primary Outcome Measure

Number of Patients With Grade 3 and Grade 4 Treatment-related Adverse Events (TRAEs) [ Time Frame: Up to 6 months ]

Locations (2)

FacilityCityStateZIPSite coordinators
Research SiteGainesvilleGeorgia30501-
Research SiteKnoxvilleTennessee37920-

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