Clinical trial NCT03035890: Hypofractionated Radiation Therapy to Improve Immunotherapy Response in Non-Small Cell Lung Cancer
Official title: Use of Response-Adapted Hypofractionated Radiation Therapy to Potentiate the Systemic Immune Response to Checkpoint Inhibitors in Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non Small Cell Lung Cancer Metastatic
Keywords: NSCLC
Lung Cancer
Non Small Cell Lung Cancer
Lead sponsor: West Virginia University
Sponsor class: OTHER
Collaborators: name: West Virginia Clinical and Translational Science Institute
First posted: 2017-01-30
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to Best Overall Response
timeFrame: From the start of treatment until disease progression up to 2 years.
Secondary outcomes:
measure: Time to Progression Free Survival
timeFrame: From the start of treatment until the date of documented progression or death assessed up to 2 years
measure: Overall Survival
timeFrame: From the start of treatment until the date date of death, or the last follow up date on which the participant was reported alive, assessed up to 2 years
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: WVU Cancer Institute - Mary Babb Randolph Cancer Center
state: West Virginia
Study officials:
affiliation: West Virginia University
name: Mohammad Shaikh, MD
role: PRINCIPAL_INVESTIGATOR
References: