Immunotherapy in Combination With Chemoradiation in Patients With Advanced Solid Tumors

Part of paid clinical trials in Tucson, Arizona.

Sponsor
AstraZeneca
Study ID
NCT03509012
Phase
PHASE1
Status
Completed

Conditions

  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma, Squamous Cell of Head and Neck
  • Small Cell Lung Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 110 Years
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — DRUG
    IV (intravenous)
  • Tremelimumab — DRUG
    IV
  • Cisplatin (dose level 4) — DRUG
    IV
  • Cisplatin (dose level 3) — DRUG
    IV
  • Carboplatin (dose level 1) — DRUG
    IV
  • Carboplatin (dose level 2) — DRUG
    IV
  • Etoposide (dose level 1) — DRUG
    IV
  • Etoposide (dose level 2) — DRUG
    IV
  • Paclitaxel — DRUG
    IV
  • Pemetrexed — DRUG
    IV
  • External beam radiation (dose level 1) — RADIATION
    radiation therapy
  • External beam radiation (dose level 2) — RADIATION
    radiation therapy
  • External beam radiation (hyperfractionated) — RADIATION
    radiation therapy
  • Cisplatin (dose level 1) — DRUG
    IV
  • Cisplatin (dose level 2) — DRUG
    IV
  • External beam radiation (standard) — RADIATION
    radiation therapy

Study Details

This is an open-label, multicenter, phase I study to evaluate the safety and tolerability of durvalumab ± tremelimumab in combination with chemoradiation in patients with advanced solid tumors

Key Dates

Start date
May 2, 2018
Status verified
Jan 2025
Primary completion
Dec 31, 2020
Completion
Jan 8, 2025

Study Design

Enrollment
105 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: HNSCC Arm 1
    Durvalumab + cisplatin with radiation in patients with locally advanced squamous cell carcinoma of the head and neck (HNSCC)
  • Experimental: NSCLC Arm 1
    Durvalumab + cisplatin and etoposide with radiation in patients with locally advanced, unresectable (Stage III) non-small-cell lung cancer (NSCLC)
  • Experimental: NSCLC Arm 2
    Durvalumab + carboplatin and paclitaxel with radiation in patients with locally advanced, unresectable (Stage III) non-small-cell lung cancer (NSCLC)
  • Experimental: NSCLC Arm 3
    Investigator's choice of carboplatin and pemetrexed OR cisplatin and pemetrexed
  • Experimental: SCLC Arm 1
    Patients should start with cisplatin, but if cisplatin is not tolerated, they have the option to switch to carboplatin
  • Experimental: SCLC Arm 2
    Patients with limited-stage small-cell lung cancer (SCLC) should start with cisplatin, but if cisplatin is not tolerated, they have the option to switch to carboplatin
  • Experimental: SCLC Arm 3
    Patients should start with cisplatin, but if cisplatin is not tolerated, they have the option to switch to carboplatin. Note: Arm 3 will only be opened if the regimen in SCLC Arm 1 is safe and tolerable.
  • Experimental: SCLC Arm 4
    Patients should start with cisplatin, but if cisplatin is not tolerated, they have the option to switch to carboplatin Note: Arm 4 will only be opened if the regimen in SCLC Arm 2 is safe and tolerable.

Primary Outcome Measure

Number of subjects with Dose Limiting Toxicities (DLTs) [ Time Frame: From first dose of durvalumab until 28 days after completion of radiation therapy ]

Locations (3)

FacilityCityStateZIPSite coordinators
Research SiteTucsonArizona85719-
Research SiteAuroraColorado80045-
Research SiteHoustonTexas77090-

Find similar trials in Tucson, AZ

By research site
Research Site· Tucson, AZResearch Site· Aurora, COResearch Site· Houston, TX

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