Last updated on June 2019

Accelerated Hypofractionated or Conventionally Fractionated Radiotherapy and Durvalumab in Treating Patients With Stage II-III Non-small Cell Lung Cancer


Brief description of study

This phase I trial studies how well giving accelerated hypofractionated or conventionally fractionated radiation therapy and durvalumab works in treating patients with stage II-III non-small cell lung cancer. Accelerated hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Conventionally fractionated radiation therapy delivers smaller doses of radiation therapy over time and may kill more tumor cells and have fewer side effects. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving accelerated hypofractionated radiation therapy or conventionally fractionated radiation therapy with durvalumab will work better in treating patients with non-small cell lung cancer.

Detailed Study Description

PRIMARY OBJECTIVES:

I. To evaluate if the addition of MEDI4736 (durvalumab) to two schedules of radiation therapies (60 Gy in 30 fractions or 60 Gy in 15 fractions) is safe.

SECONDARY OBJECTIVES:

I. To examine if the addition of MEDI4736 (durvalumab) to radiation therapy is feasible.

II. To assess toxicities associated with the addition of MEDI4736 (durvalumab) to radiation therapy.

III. To obtain preliminary estimates of progression-free survival (PFS), using Response Evaluation Criteria in Solid Tumors (RECIST) guidelines, in patients who received MEDI4736 (durvalumab) added to radiation.

EXPLORATORY OBJECTIVES:

I. To assess the impact the addition of MEDI4736 (durvalumab) has on progression-free survival, using immune-related response criteria (irRC) guidelines.

II. To assess the changes in circulating tumor cells (CTCs) and various immune parameters during treatment with durvalumab and radiotherapy and changes after completion of treatment.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive durvalumab intravenously (IV) over 60 minutes on day 1 starting 2 weeks prior to radiation therapy. Treatment repeats every 4 weeks for 13 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo accelerated hypofractionated radiation therapy (ACRT) 1 fraction per day, 5 days per week for 15 fractions.

ARM II: Patients receive durvalumab as in Arm I. Patients also undergo conventionally fractionated radiation therapy 1 fraction per day, 5 days per week for 30 fractions.

After completion of study treatment, patients are followed up every 3 months for 1 year and then every 4 months for 1 year.

Clinical Study Identifier: NCT03801902

Find a site near you

Start Over

Mid-Michigan Physicians-Lansing

Lansing, MI United States
1.61miles
  Connect »

McLaren-Greater Lansing

Lansing, MI United States
2.21miles
  Connect »

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


Receive Emails About New Clinical Trials!

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.