A Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients With Resectable Non-small Cell Lung Cancer

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
AstraZeneca
Study ID
NCT03800134
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — DRUG
    1500mg on Day 1 of each 3-week cycle for 4 cycles during the neoadjuvant period and 1500mg on Day 1 of each 4-week cycle for 12 cycles during the adjuvant period
  • Placebo — OTHER
    Day 1 of each 3-week cycle for 4 cycles during the neoadjuvant period and Day 1 of each 4-week cycle for 12 cycles during the adjuvant period
  • Carboplatin — DRUG
    Area under the curve of 5/6 on Day 1 of each 3-week cycle for 4 cycles
  • Cisplatin — DRUG
    75 mg/m2 on Day 1 of each 3-week cycle, for 4 cycles
  • Pemetrexed — DRUG
    500 mg/m2 on Day 1 of each 3-week cycle for 4 cycles.
  • Paclitaxel — DRUG
    200mg/m2 on Day 1 of each 3-week cycle for 4 cycles.
  • Gemcitabine — DRUG
    1250 mg/m2 on Day 1 and Day 8 of each 3-week cycle, for 4 cycles.
  • Surgery — PROCEDURE
    Expected within 40 days from the last dose of Investigational Product following the completion of neoadjuvant treatment.

Study Details

This is a Phase III, randomized, double-blind, placebo-controlled, multi-center international study assessing the activity of durvalumab and chemotherapy administered prior to surgery compared with placebo and chemotherapy administered prior to surgery in terms of pathological complete response.

Key Dates

Start date
Dec 6, 2018
Status verified
Jun 2025
Primary completion
Nov 10, 2022
Completion
Sep 11, 2028

Study Design

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

Arms

  • Experimental: Arm 1: Durvalumab with platinum-based chemotherapy
    Patients will receive durvalumab 1500 mg in combination with platinum-based chemotherapy every 3 weeks for up to 4 cycles prior to surgery, followed by durvalumab 1500 mg monotherapy every 4 weeks for up to 12 cycles after surgery unless disease is deemed unresectable, disease recurrence, or unacceptable toxicity The platinum-based chemotherapy will be based on tumour histology and Investigator discretion: * cisplatin with pemetrexed * carboplatin with pemetrexed * carboplatin with paclitaxel * cisplatin with gemcitabine (or carboplatin with gemcitabine for patients who have comorbidities or who are unable to tolerate cisplatin per the investigator's judgment)
  • Placebo Comparator: Arm 2: Placebo with platinum-based chemotherapy
    Patients will receive placebo in combination with platinum-based chemotherapy every 3 weeks for up to 4 cycles prior to surgery, followed by placebo monotherapy every 4 weeks for up to 12 cycles after surgery unless disease is deemed unresectable, disease recurrence, or unacceptable toxicity The platinum-based chemotherapy will be based on tumour histology and Investigator discretion: * cisplatin with pemetrexed * carboplatin with pemetrexed * carboplatin with paclitaxel * cisplatin with gemcitabine (or carboplatin with gemcitabine for patients who have comorbidities or who are unable to tolerate cisplatin per the investigator's judgment)

Primary Outcome Measure

Pathological Complete Response (pCR) in modified intent-to-treat (mITT) population [ Time Frame: Up to approximately 15 weeks after randomization ]

Locations (31)

FacilityCityStateZIPSite coordinators
Research SitePhoenixArizona85054-
Research SiteDuarteCalifornia91010-
Research SiteOrangeCalifornia92868-
Research SiteAuroraColorado80012-
Research SiteBoca RatonFlorida33486-
Research SiteJacksonvilleFlorida32256-
Research SiteChicagoIllinois60612-
Research SiteWichitaKansas67214-
Research SiteAshlandKentucky41101-
Research SiteLexingtonKentucky40513-
Research SiteSilver SpringMaryland20910-
Research SiteTowsonMaryland21204-
Research SiteDuluthMinnesota55805-
Research SiteMinneapolisMinnesota55404-
Research SiteMorristownNew Jersey07962-
Research SiteNew YorkNew York10028-
Research SiteNew YorkNew York10065-
Research SiteShirleyNew York11967-
Research SiteDurhamNorth Carolina27710-
Research SiteBendOregon97701-
Research SiteMedfordOregon97504-
Research SitePittsburghPennsylvania15212-
Research SiteCharlestonSouth Carolina29414-
Research SiteCharlestonSouth Carolina29424-
Research SiteAustinTexas78745-
Research SiteFort WorthTexas76104-
Research SiteHoustonTexas77030-
Research SiteHoustonTexas77090-
Research SiteFairfaxVirginia22031-
Research SiteKirklandWashington98034-
Research SiteSeattleWashington98109-

Find similar trials in Phoenix, AZ

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Research Site· Phoenix, AZResearch Site· Duarte, CAResearch Site· Orange, CAResearch Site· Aurora, COResearch Site· Boca Raton, FLResearch Site· Jacksonville, FL

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