NCT06576635

LUNG-05: Investigating Chemotherapy Effectiveness for Non-Small Cell Lung Cancer (NSCLC) Metastatic Patients

LUNG-05: Investigating Chemotherapy Effectiveness for NSCLC Metastatic Patients

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 29 (estimated)
• Sponsor: University of Illinois at Chicago · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• NSCLC

Interventions

Type	Name	Description
DRUG	Docetaxel	75 mg/m2 IV over 1-hour Day 1 of each 21-day cycle
DRUG	Paclitaxel	135 mg/m2 IV over 3 hours Day 1 of each 21-day cycle
DRUG	Gemcitabine	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
DRUG	Pemetrexed	500 mg/m2 IV over 10 minutes on Day 1 of each 21-day cycle
DRUG	Vinorelbine	30 mg/m2 IV through a weekly injection over 6-19 minutes on Days 1, 8, and 15 of each 21-day cycle

Timeline

• Start date: 2024-12-16
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2024-08-29
• Last updated: 2026-01-20

Locations

1 site across 1 country: United States