ADMIRAL Trial: Adaptive Mediastinal Radiation With Chemo-Immunotherapy

Part of paid clinical trials in Seattle, Washington.

Sponsor
University of Washington
Study ID
NCT04372927
Phase
PHASE2
Status
Terminated

Conditions

  • Locally Advanced Lung Non-Small Cell Carcinoma
  • Stage III Lung Cancer AJCC v8
  • Stage IIIA Lung Cancer AJCC v8
  • Stage IIIB Lung Cancer AJCC v8
  • Stage IIIC Lung Cancer AJCC v8

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cisplatin — DRUG
    Given IV
  • Durvalumab — BIOLOGICAL
    Given IV
  • Etoposide — DRUG
    Given IV
  • Hypofractionated Radiation Therapy — RADIATION
    Undergo hypofractionated radiation therapy
  • Pemetrexed — DRUG
    Given IV

Study Details

This phase II trial studies two questions in patients with stage III NSCLC: 1) does it improve cancer control to add the drug Durvalumab, a type of immunotherapy, earlier in the treatment course; and 2) by intensifying treatment with durvalumab, is it possible to avoid mediastinal radiation to decrease side effects, without decreasing cancer control?

Key Dates

Start date
Dec 10, 2021
Status verified
May 2023
Primary completion
Apr 23, 2022
Completion
Apr 23, 2022

Study Design

Enrollment
1 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (chemotherapy, durvalumab, radiation therapy)
    Patients with squamous cell cancer receive standard of care chemotherapy consisting of cisplatin on days 1, 8, 29, and 36, and etoposide on days 1-5 and 29-33. Cycles repeat every 4 weeks for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients with non-squamous cell cancer receive standard of care chemotherapy consisting of cisplatin and pemetrexed on days 1, 22, and 43. Cycles repeat every 3 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. All patients receive durvalumab IV over 1 hour Q4W. Radiation to the primary tumor will be given over 8-15 fractions during weeks 1-3 of chemotherapy. For patients who have residual disease in the mediastinal lymph nodes at week 9, radiation will be given to the lymph nodes starting week 11. Durvalumab is given for 2 years after completion of radiation in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

1 Year Progression-free Survival Rate (PFS) [ Time Frame: Study enrollment to disease progression or death, whichever occurs first, for up to 1 year ]

Locations (1)

FacilityCityStateZIPSite coordinators
Fred Hutch/University of Washington Cancer ConsortiumSeattleWashington98109-

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By research site
Fred Hutch/University of Washington Cancer Consortium· Seattle, WA

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