Study of Durvalumab+Olaparib or Durvalumab After Treatment With Durvalumab and Chemotherapy in Patients With Lung Cancer (ORION)

Part of paid clinical trials in Bonita Springs, Florida.

Sponsor
AstraZeneca
Study ID
NCT03775486
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Non-small Cell Lung Cancer NSCLC

Eligibility Criteria

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

Interventions

  • Durvalumab — DRUG
    Initial therapy phase: IV infusion q3w for 4 cycles. Maintenance phase: IV infusion q4w.
  • Placebo for Olaparib — DRUG
    Matching tablet
  • Olaparib — DRUG
    150-mg tablets (2 × 150-mg tablets for 300-mg dose) 100-mg tablet available if dose reductions are required
  • Nab-paclitaxel+carboplatin — DRUG
    Standard of Care chemotherapy (squamous and non-squamous patients)
  • Gemcitabine+carboplatin — DRUG
    Standard of Care chemotherapy (squamous patients only)
  • Pemetrexed+carboplatin — DRUG
    Standard of Care chemotherapy (non-squamous patients only)
  • Gemcitabine+cisplatin — DRUG
    Standard of Care chemotherapy (squamous patients only)
  • Pemetrexed+cisplatin — DRUG
    Standard of Care chemotherapy (non-squamous patients only)

Study Details

This is a randomized, double-blind, multi-center, global Phase II study to determine the efficacy and safety of Durvalumab plus Olaparib combination therapy compared with Durvalumab monotherapy as maintenance therapy in patients whose disease has not progressed following Standard of Care (SoC) platinum-based chemotherapy with Durvalumab as first-line treatment in patients with Stage IV non small-cell lung cancer (NSCLC) with tumors that lack activating epidermal growth factor receptor (EGFR) mutations and anaplastic lymphoma kinase (ALK) fusions.

Key Dates

Start date
Dec 21, 2018
Status verified
Apr 2026
Primary completion
Jan 11, 2021
Completion
Sep 27, 2026

Study Design

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

Arms

  • Experimental: Durvalumab/Olaparib Combination Therapy
    Durvalumab/Olaparib Combination Therapy: Durvalumab/SoC chemotherapy (initial therapy phase) followed by Durvalumab/Olaparib (maintenance phase)
  • Experimental: Durvalumab Monotherapy
    Durvalumab Monotherapy: Durvalumab/SoC chemotherapy (initial therapy phase) followed by Durvalumab/placebo (maintenance phase)

Primary Outcome Measure

Progression-free Survival [ Time Frame: From randomization until date of objective radiological disease progression or death, or last evaluable assessment in the absence of progression, up to 18 months ]

Locations (9)

FacilityCityStateZIPSite coordinators
Research SiteBonita SpringsFlorida34135-
Research SiteSt. PetersburgFlorida33705-
Research SiteTallahasseeFlorida32308-5304-
Research SiteWest Palm BeachFlorida33401-
Research SiteKansas CityMissouri64132-
Research SiteBethlehemPennsylvania18015-
Research SiteChattanoogaTennessee37404-
Research SiteNashvilleTennessee37203-
Research SiteHoustonTexas77090-

Find similar trials in Bonita Springs, FL

By research site
Research Site· Bonita Springs, FLResearch Site· St. Petersburg, FLResearch Site· Tallahassee, FLResearch Site· West Palm Beach, FLResearch Site· Kansas City, MOResearch Site· Bethlehem, PA

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