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

NCT03035890 | Completed Results DMC FDA Device

• 1 other identifier: WVU010516
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Non Small Cell Lung Cancer Metastatic

Keywords

NSCLC; Lung Cancer; Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Time to Best Overall Response

  Time to Best Overall Response is measured in months from the start of treatment until the best response is achieved. Both RECIST v1.1 and irRC criteria will be used. RECIST Criteria: Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): ≥30% decrease in the sum of the diameters of target lesions. Stable Disease (SD): Neither sufficient shrinkage for PR nor sufficient increase for PD. Progressive Disease (PD): ≥20% increase in the sum of the diameters of target lesions or appearance of new lesions. irRC Criteria: Complete Response (irCR): Disappearance of all lesions in two consecutive observations ≥4 weeks apart. Partial Response (irPR): ≥50% decrease in tumor burden compared with baseline in two observations ≥4 weeks apart. Stable Disease (irSD): Neither sufficient decrease for irPR nor sufficient increase for irPD. Progressive Disease (irPD): ≥25% increase in tumor burden compared with nadir in two consecutive observations ≥4 weeks apart.

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

Secondary Outcomes (2)

• Time to Progression Free Survival

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

• Overall Survival

  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

Study Arms (1)

Radiation Therapy + Immunotherapy

EXPERIMENTAL

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

Radiation: Radiation; Drug: Immuno-Therapeutic Agent

Interventions

Radiation RADIATION

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)

Also known as: Hypofractionated Radiation

Radiation Therapy + Immunotherapy

Immuno-Therapeutic Agent DRUG

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.

Also known as: Immunotherapy

Radiation Therapy + Immunotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• West Virginia University: lead
• West Virginia Clinical and Translational Science Institute: collaborator

Study Sites (1)

WVU Cancer Institute - Mary Babb Randolph Cancer Center

Morgantown, West Virginia, 26506, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Radiation; Radiation Dose Hypofractionation; Immunotherapy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Physical Phenomena; Dose Fractionation, Radiation; Radiotherapy Dosage; Radiotherapy; Therapeutics; Immunomodulation; Biological Therapy

Results Point of Contact

• Title: Tara Riddle
• Organization: WVCTSI

tlr0011@hsc.wvu.edu

304-581-1829

Study Officials

• Mohammad Shaikh, MD

  West Virginia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2017
• First Posted: January 30, 2017
• Study Start: January 23, 2017
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: April 1, 2025
• Results First Posted: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)