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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 Objectives:
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;
To evaluate the impact of adding SBRT to maintenance systemic therapy versus maintenance systemic therapy alone on primary failure.
To evaluate the impact of adding SBRT to maintenance systemic therapy versus maintenance systemic therapy alone on out-of-field disease progression;
To evaluate the impact of adding SBRT to maintenance systemic therapy versus maintenance systemic therapy alone on toxicity;
To evaluate the impact of adding SBRT to maintenance systemic therapy versus maintenance systemic therapy 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)
Primary Objectives:
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;
To evaluate the impact of adding SBRT to maintenance systemic therapy versus maintenance systemic therapy alone on primary failure.
To evaluate the impact of adding SBRT to maintenance systemic therapy versus maintenance systemic therapy alone on out-of-field disease progression;
To evaluate the impact of adding SBRT to maintenance systemic therapy versus maintenance systemic therapy alone on toxicity;
To evaluate the impact of adding SBRT to maintenance systemic therapy versus maintenance systemic therapy 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)
Recruitment Status
Past Studies