This is a Single arm, Simon's two stage pilot study in which patients with Non-Small Cell Lung Cancer (NSCLC) with metastatic disease 2L and beyond will receive OncoChoice-informed chemotherapy following National Cancer Care Network (NCCN) treatment guidelines on dosage and scheduling for NSCLC FDA approved drugs.
This is a Single arm, Simon's two stage pilot study in which patients with Non-Small Cell Lung Cancer (NSCLC) with metastatic disease 2L and beyond will receive OncoChoice-informed chemotherapy following National Cancer Care Network (NCCN) treatment guidelines on dosage and scheduling for NSCLC FDA-approved drugs. After confirmation of patient eligibility and patient consent receival, patients will undergo biopsy and/or removal of malignant fluids (paracentesis/ thoracentesis/ PleurX catheter) as part of standard of care procedures. Biosamples will be shared in a timely fashion (within 24 hr post collection) with study sponsors (OncoOptima) to test drug responsiveness. Participants will undergo additional testing as deemed necessary by the treating provider. Any additional treatments will be at the discretion of the treating provider.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
29
75 mg/m2 IV over 1-hour Day 1 of each 21-day cycle
135 mg/m2 IV over 3 hours Day 1 of each 21-day cycle
1000 mg/m2 IV over 30 minutes on Days 1, 8, and 15 of each 28-day cycle or 1,250 mg/m2 IV over 30 minutes on Days 1 and 8 of each 21 day cycle
University of Illinois Cancer Center
Chicago, Illinois, United States
RECRUITINGTo estimate the objective response rate (ORR) as measured by investigator assessment in patients with metastatic NSCLC treated with at least 2L of chemotherapy who have had OncoChoice-informed treatment
The objective response rate is the proportion of all subjects with confirmed PR or CR according to investigator assessment, from the start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the start of treatment).
Time frame: Every 6-8 weeks through study completion, an average of 2 years
To estimate the 6-month progression-free survival (PFS) in 2L and beyond NSCLC patients who receive OncoChoice-informed chemotherapy regimen
PFS is defined as the time from D1 of treatment until the criteria for disease progression is met as defined by investigator-assessed criteria or death as a result of any cause.
Time frame: Day 1 of treatment through study completion, an average of 2 years
To estimate the overall survival (OS) in 2L and beyond NSCLC patients who receive OncoChoice-informed chemotherapy regimen
OS is defined as the time from D1 of treatment to death as a result of any cause.
Time frame: Day 1 of treatment through study completion, an average of 2 years
To describe changes in health-related quality of life (HRQoL) over the course of treatment following OncoChoice-informed regimen vs. standard chemotherapy
Changes in health-related quality of life (HRQoL) will be studied using self-reported and validated questionnaires that address addressing physical, physiological, emotional, and social issues
Time frame: Screening through study completion, an average of 2 years
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500 mg/m2 IV over 10 minutes on Day 1 of each 21-day cycle
30 mg/m2 IV through a weekly injection over 6-19 minutes on Days 1, 8, and 15 of each 21-day cycle