Page 11 - Delaware Medical Journal - February 2018

CANCER CLINICAL TRIAL
PROTOCOL OF THE MONTH
NRG LU002: Maintenance Systemic Therapy Versus Consolidative Stereotactic Body Radiation Therapy (SBRT) Plus Maintenance Systemic Therapy For Limited Metastatic Non-Small Cell Lung Cancer (NSCLC): A Randomized Phase II/III Trial
Primary Objective:
•Phase II: To evaluate the impact of adding SBRT to maintenance systemic therapy versus maintenance systemic therapy alone on progression-free survival for patients with metastatic NSCLC with no evidence of progression and limited metastatic sites after first- line systemic therapy
•Phase III: To evaluate the impact of adding SBRT to maintenance systemic therapy versus maintenance systemic therapy alone on overall survival for patients with metastatic NSCLC with no evidence of progression and limited metastatic sites after first-line systemic therapy
Secondary Objectives:
•To evaluate the impact of adding SBRT to maintenance systemic therapy versus maintenance systemic therapy alone on in-field local failure, alone on primary failure, alone on out-of-field disease progression, alone on toxicity, alone on duration of maintenance systemic therapy usage
•To evaluate the effect of adding SBRT to systemic therapy in limited stage IV NSCLC on Quality of Life (QOL).
•To collect biospecimens and evaluate the correlation between clinical outcomes and circulating tumor DNA (ctDNA).
Eligibility Criteria:
•Age ≥ 18 years, ECOG performance status 0, 1, or 2 within 30 days prior to registration.
•Pathologically proven diagnosis of NSCLC, with metastases (stage IV disease) present prior to registration. This includes patients newly diagnosed with metastatic disease or those initially diagnosed and treated for stage I-III NSCLC who ultimately develop metastases
•Patients must have received first-line/induction systemic therapy (at least 4 cycles) and achieved stable disease or a partial response.
•Adequate organ and hematologic/bone marrow function within 30 days prior to registration and at least 14 days after last dose of first-line/induction systemic therapy. Negative serum pregnancy test within one week prior to registration for females of childbearing potential
•Patients must have measurable disease at baseline and 3 or fewer discrete, extracranial metastatic disease sites that are technically amenable to SBRT.
•For de novo stage IV NSCLC patients (patients with metastatic disease at first presentation), primary disease must be treatable with local therapy in the form of SBRT or hypofractionated radiation. If the primary disease is found in the peripheral or central lung parenchyma without nodal disease, for instance, SBRT may be employed. If primary disease is more advanced with involvement of the mediastinum (T4 tumor, N1-N3 disease, etc.), these volumes should be technically treatable with hypofractionated radiation.
•If primary disease in the thoracic cavity was previously treated with local therapy in the form of surgery or radiation, any new local/ regional disease recurrence should be technically treatable with SBRT or hypofractionated radiation after induction systemic therapy
•Patients with brain metastases are eligible if these lesions have been previously treated and the patients have no clinical or radiographic evidence of progression prior to enrollment.
Treatment:
ARM 1: Maintenance systemic therapy should begin within 2 weeks of randomization.
ARM 2: Radiation should begin within 2 weeks of randomization, and maintenance systemic therapy should begin within 2 weeks of the completion of radiation.
For information regarding clinical trials or if you would like to have the list of open protocols emailed to you, please call the Cancer Research Office at (302) 623-4450 or email akee@christianacare.org.
Del Med J | February 2018 | Vol. 90 | No. 2 43