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

Primary Purpose

Non Small Cell Lung Cancer Metastatic

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Radiation

Immuno-Therapeutic Agent

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer Metastatic focused on measuring NSCLC, Lung Cancer, Non Small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

WVU Cancer Institute - Mary Babb Randolph Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Radiation Therapy + Immunotherapy

Arm Description

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

Outcomes

Primary Outcome Measures

Best Overall Response

Best overall response rate (complete and partial), measured on follow-up imaging as per immune-related Response Criteria (irRC) approx. every three months taking the smallest measurement recorded.

Secondary Outcome Measures

Progression Free Survival

Disease status will be evaluated based on imaging results until progression or death; assessed every three months.

Overall Survival

Amount of time from treatment until death, reported via follow up visit or phone call.

Adverse event evaluation

Adverse event will be recorded and graded based on CTCAE version 4

Quality of Life Assessment FACT-L

Access change in quality of life scores between visits using the FACT-L score. A difference of 3 points will be considered clinically significant.

Quality of Life Assessment FACT-Fatigue

Access change in quality of life between visits using the FACT- Fatigue scores. A difference of 3 points will be considered clinically significant.

Full Information

NCT ID

NCT03035890

First Posted

January 23, 2017

Last Updated

April 24, 2023

Sponsor

West Virginia University

Collaborators

West Virginia Clinical and Translational Science Institute

1. Study Identification

Unique Protocol Identification Number

NCT03035890

Brief Title

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

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Completed

Study Start Date

January 23, 2017 (Actual)

Primary Completion Date

June 30, 2022 (Actual)

Study Completion Date

June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

West Virginia University

Collaborators

West Virginia Clinical and Translational Science Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non Small Cell Lung Cancer Metastatic

Keywords

NSCLC, Lung Cancer, Non Small Cell Lung Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

35 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Radiation Therapy + Immunotherapy

Arm Type

Experimental

Arm Description

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

Intervention Type

Radiation

Intervention Name(s)

Radiation

Other Intervention Name(s)

Hypofractionated Radiation

Intervention Description

Radiation therapy will be administered in 3 or 5 fractions over 3-10 days, at a recommended dose of 8-15 Gy per fraction for 3 total fractions (total dose 24-45 Gy) or 6-10 Gy per fraction for 5 total fractions (total dose 30-50 Gy)

Intervention Type

Drug

Intervention Name(s)

Immuno-Therapeutic Agent

Other Intervention Name(s)

Immunotherapy

Intervention Description

Immune checkpoint inhibitors that are FDA approved for use in patients with metastatic NSCLC will be acceptable for use concurrently with radiotherapy in this trial. The choice of agents will be at the treating medical oncologist's discretion, and include: Nivolumab 240mg or 3 mg/kg once every 2 weeks (14 day cycle) Pembrolizumab 200mg or 2 mg/kg once every 3 weeks (21 day cycle) Atezolizumab 1200 mg once every 3 weeks (21 day cycle) These agents should be continued per standard of care until either disease progression or unacceptable toxicity.

Primary Outcome Measure Information:

Title

Best Overall Response

Description

Best overall response rate (complete and partial), measured on follow-up imaging as per immune-related Response Criteria (irRC) approx. every three months taking the smallest measurement recorded.

Time Frame

From the start of treatment until disease progression up to 2 years.

Secondary Outcome Measure Information:

Title

Progression Free Survival

Description

Disease status will be evaluated based on imaging results until progression or death; assessed every three months.

Time Frame

From the start of treatment until the date of documented progression or death assessed up to 2 years

Title

Overall Survival

Description

Amount of time from treatment until death, reported via follow up visit or phone call.

Time Frame

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

Title

Adverse event evaluation

Description

Adverse event will be recorded and graded based on CTCAE version 4

Time Frame

From the time of consent at 3 month intervals until 1 year after treatment has stopped or death

Title

Quality of Life Assessment FACT-L

Description

Access change in quality of life scores between visits using the FACT-L score. A difference of 3 points will be considered clinically significant.

Time Frame

3 month intervals from the start of treatment until progression up to 2 years

Title

Quality of Life Assessment FACT-Fatigue

Description

Access change in quality of life between visits using the FACT- Fatigue scores. A difference of 3 points will be considered clinically significant.

Time Frame

3 month intervals from the start of treatment until progression up to 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joshua Weir, MD

Organizational Affiliation

WVUCI - Mary Babb Randolph Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

WVU Cancer Institute - Mary Babb Randolph Cancer Center

City

Morgantown

State/Province

West Virginia

ZIP/Postal Code

26506

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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