LUNG-05: Investigating Chemotherapy Effectiveness for Non-Small Cell Lung Cancer (NSCLC) Metastatic Patients
NCT Number: NCT06576635
Acronym: LUNG-05
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: NSCLC
Interventions: DRUG: Docetaxel|DRUG: Paclitaxel|DRUG: Gemcitabine|DRUG: Pemetrexed|DRUG: Vinorelbine
Sponsor: University of Illinois at Chicago
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 29
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2026-09

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.

Primary Outcome Measures: Objective Response Rate (ORR): ORR is defined as number of patients with complete response (CR), ORR is defined as number of patients with complete response (CR) divided by all eligible and treated patients. Responses are evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) guideline. CR is defined as disappearance of all target and non-target lesions, 8 weeks|Objective Response Rate (ORR): ORR is defined as number of patients with partial response (PR), ORR is defined as number of patients with partial response (PR) divided by all eligible and treated patients. Responses are evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) guideline. CR is defined as disappearance of all target and non-target lesions, 8 weeks
Secondary Outcome Measures: Number of participants that have Progression Free Survival (PFS) rate, PFS is defined as the time from enrollment to death or disease progression, whichever occurred first, 8 weeks|Number of participants that have an overall survival (OS) rate, OS is defined as the time from enrollment to death or date of last known alive, 1 month|Number of participants that have Health-related Quality of Life (HRQoL) issues, HRQoL will be evaluated via self-reported and validated questionnaires, addressing physical, physiological, emotional, and social issues. High score means worse health outcomes and low score means better health outcomes, Screening|Number of participants that have Health-related Quality of Life (HRQoL) issues, HRQoL will be evaluated via self-reported and validated questionnaires, addressing physical, physiological, emotional, and social issues. High score means worse health outcomes and low score means better health outcomes, 8 weeks|Number of participants that have Health-related Quality of Life (HRQoL) issues, HRQoL will be evaluated via self-reported and validated questionnaires, addressing physical, physiological, emotional, and social issues. High scores means worse health outcomes and low score means better health outcomes, 8 weeks|Number of participants that have Health-related Quality of Life (HRQoL) issues, HRQoL will be evaluated via self-reported and validated questionnaires, addressing physical, physiological, emotional, and social issues. High scores means worse health outcomes and low score means better health outcomes, 30 days after last dose|Number of participants that have Health-related Quality of Life (HRQoL) issues, HRQoL will be evaluated via self-reported and validated questionnaires, addressing physical, physiological, emotional, and social issues. High scores means worse health outcomes and low score means better health outcomes, 3 months after last dose|Number of participants that have Health-related Quality of Life (HRQoL) issues, HRQoL will be evaluated via self-reported and validated questionnaires, addressing physical, physiological, emotional, and social issues. High scores means worse health outcomes and low score means better health outcomes, 6 months after last dose