Hypofractionated Radiation Therapy to Improve Immunotherapy Response in Non-Small Cell Lung Cancer

West Virginia University

Status: Completed

Conditions: Non Small Cell Lung Cancer Metastatic

Treatments: Radiation: Radiation; Drug: Immuno-Therapeutic Agent

Study type: Interventional

Funder types: Other

Identifiers

NCT03035890

WVU010516

Details and patient eligibility

About

This study includes the additional use of radiation therapy in combination immunotherapy in order to determine whether the radiation may improve the response of non-small cell lung cancer to immunotherapy and to monitor any side effects.

Full description

Preclinical data suggest that radiation therapy may be uniquely suited to combine with immune checkpoint inhibitors, since radiation can disrupt a tumor's physical barriers to T-cell infiltration and augment antigen presentation, thus serving as an "in situ personalized vaccine" to activate the immune system and potentially enhance the systemic response.

The rationale for this study is to determine the safety and efficacy of combined immune checkpoint inhibitors and radiation therapy in metastatic non-small cell lung cancer patients.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Stage IV metastatic Non Small Cell Lung Cancer
• Measurable disease of at least 1.5 cm in greatest dimension at least 2 non-irradiated sites (except for lymph nodes, in which the short-axis dimension must be at least 1.5cm). There must be at least 1 visceral organ metastasis outside of the brain.
• History of prior cytotoxic chemotherapy (with or without concomitant radiation therapy) with subsequent distant (metastatic) disease relapse, or progression of disease while on chemotherapy.
• Participant must be planned to receive (or actively receiving) standard of care checkpoint inhibitor immune therapy. For those patients actively receiving checkpoint inhibitor immune therapy the duration of immune therapy at the time of enrollment must be 4 months or less.
• Life expectancy greater than 3 months

Exclusion criteria

• Active autoimmune disease, primary immunodeficiency syndrome, HIV/AIDS, or hepatitis B or C
• Oral corticosteroid dependency
• Uncontrolled or untreated active brain metastases/CNS disease
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Radiation Therapy + Immunotherapy

Experimental group

Description:

3-5 fraction course of radiation therapy to target lesion concurrent with an immuno-therapeutic agent

Treatment:

Drug: Immuno-Therapeutic Agent

Radiation: Radiation