Cancer Type: Genitourinary
Study Type: Treatment
NCT#: NCT03137771
Phase: Phase II/III
Principal Investigator: Perez, Bradford
Maintenance Systemic Therapy versus Local Consolidative Therapy (Lct) Plus Maintenance Systemic Therapy for Limited Metastatic Non-Small Cell Lung Cancer (Nsclc): A Randomized Phase II/III Trial
Primary Objectives 1.1.1 Phase II: To evaluate the impact of adding LCT (local consolidative therapy) 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 1.1.2 Phase III: To evaluate the impact of adding LCT 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 1.2 Secondary Objectives (18-MAY-2018) 1.2.1 To evaluate the impact of adding LCT to maintenance systemic therapy versus maintenance systemic therapy alone on in-field local failure; 1.2.2 To evaluate the impact of adding LCT to maintenance systemic therapy versus maintenance systemic therapy alone on the time to development of new lesions; 1.2.3 To evaluate the impact of adding LCT to maintenance systemic therapy versus maintenance systemic therapy alone on toxicity; 1.2.4 To evaluate the impact of adding LCT to maintenance systemic therapy versus maintenance systemic therapy alone on duration of maintenance systemic therapy usage. 1.2.5 To evaluate the effect of adding LCT to systemic therapy in limited stage IV NSCLC on Quality of Life (QOL) 1.2.6 To collect biospecimens and evaluate the correlation between clinical outcomes and circulating tumor DNA (ctDNA)
Chemotherapy (NOS); Immunotherapy
Alimta (Pemetrexed); Gemzar (gemcitabine); Pembrolizumab (Keytruda); Pemetrexed (); Taxotere (docetaxel); docetaxel (); gemcitabine ()
If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.
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