A Study of Durvalumab as Consolidation Therapy in Non-Small Cell Lung Cancer Patients

Sponsor
AstraZeneca
Study ID
NCT03706690
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

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

Interventions

  • Durvalumab — DRUG
    Durvalumab 1500 mg every 4 weeks \[q4w\] intravenously \[iv\] until clinical progression/ deterioration or confirmed radiological progression.
  • Placebo — OTHER
    Matching placebo for infusion every 4 weeks iv until clinical progression/deterioration or confirmed radiological progression

Study Details

This is a Phase III, randomised, double-blind, placebo-controlled, multicentre study assessing the efficacy and safety of durvalumab compared with placebo, as consolidation therapy in patients with locally advanced, unresectable, non-small cell lung cancer (Stage III), who have not progressed following definitive, platinum-based, chemoradiation therapy.

Key Dates

Start date
Nov 27, 2018
Status verified
May 2026
Primary completion
Jun 23, 2024
Completion
Feb 26, 2027

Study Design

Enrollment
407 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Durvalumab Therapy
    Durvalumab (PD-L1 monoclonal antibody)1500 mg every 4 weeks \[q4w\] intravenously \[iv\] until clinical progression/deterioration or confirmed radiological progression)
  • Placebo Comparator: Placebo Therapy
    Placebo (matching placebo for infusion every 4 weeks iv until clinical progression/deterioration or confirmed radiological progression)

Primary Outcome Measure

Progression-Free Survival (PFS) (Modified Intent-to-Treat [mITT] Set) [ Time Frame: Tumor scans performed at screening, every 8 weeks ±1 week up to 48 weeks, and then every 12 weeks ±1 week thereafter until confirmed PD. Assessed up to the DCO date 23-Jun-2024 (a maximum of approximately 2035 days) ]

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