Hypofractionated Radiation Therapy to Improve Immunotherapy Response in Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT03035890|
Recruitment Status : Recruiting
First Posted : January 30, 2017
Last Update Posted : December 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Non Small Cell Lung Cancer Metastatic||Radiation: Radiation Drug: Immuno-Therapeutic Agent||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Use of Response-Adapted Hypofractionated Radiation Therapy to Potentiate the Systemic Immune Response to Checkpoint Inhibitors in Non-Small Cell Lung Cancer|
|Actual Study Start Date :||January 23, 2017|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
Experimental: Radiation Therapy + Immunotherapy
3-5 fraction course of radiation therapy to target lesion concurrent with an immuno-therapeutic agent
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)
Other Name: Hypofractionated Radiation
Drug: Immuno-Therapeutic Agent
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:
These agents should be continued per standard of care until either disease progression or unacceptable toxicity.
Other Name: Immunotherapy
- Best Overall Response [ Time Frame: From the start of treatment until disease progression up to 2 years. ]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.
- Progression Free Survival [ Time Frame: From the start of treatment until the date of documented progression or death assessed up to 2 years ]Disease status will be evaluated based on imaging results until progression or death; assessed every three months.
- Overall Survival [ 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 ]Amount of time from treatment until death, reported via follow up visit or phone call.
- Adverse event evaluation [ Time Frame: From the time of consent at 3 month intervals until 1 year after treatment has stopped or death ]Adverse event will be recorded and graded based on CTCAE version 4
- Quality of Life Assessment FACT-L [ Time Frame: 3 month intervals from the start of treatment until progression up to 2 years ]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 [ Time Frame: 3 month intervals from the start of treatment until progression up to 2 years ]Access change in quality of life between visits using the FACT- Fatigue scores. A difference of 3 points will be considered clinically significant.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03035890
|Contact: Malcolm Mattes, MDfirstname.lastname@example.org|
|Contact: Carla Ross, RNemail@example.com|
|United States, West Virginia|
|WVU Cancer Institute - Mary Babb Randolph Cancer Center||Recruiting|
|Morgantown, West Virginia, United States, 26506|
|Contact: Malcolm Mattes, MD 304-598-4706 firstname.lastname@example.org|
|Principal Investigator: Malcolm Mattes, MD|
|Sub-Investigator: Mohammed Almubarak, MD|
|Sub-Investigator: Geraldine Jacobson, MD|
|Sub-Investigator: Patrick Ma, MD|
|Sub-Investigator: Aaron Provenzano, DO|
|Sub-Investigator: Gary Marano, MD|
|Sub-Investigator: Timothy Eubank, PhD|
|Sub-Investigator: Matthew Smolkin, MD|
|Principal Investigator:||Malcolm Mattes, MD||WVUCI - Mary Babb Randolph Cancer Center|