Study of Durvalumab Following Radiation Therapy in Patients With Stage 3 Unresectable NSCLC Ineligible for Chemotherapy

Part of paid clinical trials in Tucson, Arizona.

Sponsor
AstraZeneca
Study ID
NCT04249362
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Durvalumab — DRUG
    All patients will receive 1500 mg durvalumab via IV infusion q4w for up to a maximum of 12 months.

Study Details

This is a Phase II open-label, single-arm, multicenter, international study to evaluate the clinical activity of durvalumab in patients with Stage III unresectable NSCLC who are deemed to be ineligible for chemotherapy per Investigator assessment. Patients will be enrolled into 2 cohorts according to radiotherapy pretreatment dose (Cohort A: standard radiation therapy \[60 gray (Gy) ± 10% or hypofractionated bioequivalent dose (BED)\]; Cohort B: palliative radiation therapy \[40 to \< 54 Gy or hypofractionated BED\])

Key Dates

Start date
Nov 26, 2020
Status verified
Dec 2024
Primary completion
Mar 30, 2023
Completion
Nov 25, 2024

Study Design

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

Arms

  • Experimental: Cohort A
    Patients received standard radiotherapy \[60 gray (Gy) ± 10% or hypofractionated BED\] prior to study entry.
  • Experimental: Cohort B
    Patients received palliative radiotherapy \[40 to \< 54 Gy or hypofractionated BED\] prior to study entry.

Primary Outcome Measure

Number of Patients With Grade 3 and Grade 4 Possibly-related Adverse Events (PRAEs) [ Time Frame: From first dose of durvalumab treatment until 6 months after initiation of durvalumab treatment ]

Locations (3)

FacilityCityStateZIPSite coordinators
Research SiteTucsonArizona85704-
Research SiteTampaFlorida33612-
Research SiteRoyal OakMichigan48073-

Find similar trials in Tucson, AZ

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Research Site· Tucson, AZResearch Site· Tampa, FLResearch Site· Royal Oak, MI

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