Trials / Terminated

TerminatedNCT04372927

ADMIRAL Trial: Adaptive Mediastinal Radiation With Chemo-Immunotherapy

Adaptive-Dose to Mediastinum With Immunotherapy (Durvalumab MEDI4736) and Radiation in Locally-Advanced Non-Small Cell Lung Cancer

Status: Terminated
Phase: Phase 2
Study type: Interventional
Enrollment: 1 (actual)

Sponsor: University of Washington · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

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?

Detailed description

OUTLINE: Patients will receive platinum doublet chemotherapy per standard of care with durvalumab for 8 weeks, concurrent with a short course of radiation to the primary lung tumor. Patients will then undergo repeat evaluation of the mediastinal lymph nodes. If there is no cancer in the lymph nodes, patients will receive 2 years of adjuvant durvalumab. If there is still cancer in the lymph nodes, patients will receive 6 weeks of radiation to the mediastinal lymph nodes, and 2 years of adjuvant durvalumab. After the completion of study treatment, patients are followed up for 12 months.

Conditions

Interventions

Type	Name	Description
DRUG	Cisplatin	Given IV
BIOLOGICAL	Durvalumab	Given IV
DRUG	Etoposide	Given IV
RADIATION	Hypofractionated Radiation Therapy	Undergo hypofractionated radiation therapy
DRUG	Pemetrexed	Given IV

Timeline

Start date: 2021-12-10
Primary completion: 2022-04-23
Completion: 2022-04-23
First posted: 2020-05-04
Last updated: 2023-06-13
Results posted: 2023-06-13

Locations

1 site across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT04372927. Inclusion in this directory is not an endorsement.