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

Not Applicable

Recruiting

• Conditions: NSCLC
• Interventions: Drug: Docetaxel; Drug: Paclitaxel; Drug: Gemcitabine; Drug: Pemetrexed; Drug: Vinorelbine

• Registration Number: NCT06576635
• Lead Sponsor: University of Illinois at Chicago

Brief 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.

Study Timeline

• Study First Submitted: 2024-08-26
• Study First Submitted QC: 2024-08-26
• Study First Posted: 2024-08-29
• Study Start: 2024-12-16
• Status Verified: 2025-11
• Last Update Submitted: 2025-11-04
• Last Update Posted: 2025-11-06
• Primary Completion: 2026-09
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

• Age ≥ 18 years of age at time of consent
• ECOG performance status score of ≤2
• Advanced non-small cell lung cancer to meet histologically confirmed Stage IV NSCLC documented by biopsy.
• Patient has received at least 1 prior line of systemic therapy for Stage IV NSCLC (including but not limited to targeted therapy and are now only considering SOC chemotherapy for 2L and beyond).
• Demonstrates adequate organ function; labs must be within treatment parameters for the individual institutional treatment plans for specific therapeutic agents. All screening labs to be obtained within 30 days prior to registration.
• Must have not received any cancer treatment for at least 2 weeks.
• Must be a candidate for small molecule drug treatment.
• Participants or their LAR must be able to provide written informed consent and HIPAA authorization for release of personal health information, via an approved UIC Institutional Review Board (IRB) informed consent form and HIPAA authorization.
• Women of childbearing potential must not be pregnant or breast-feeding. A negative serum or urine pregnancy test is required per institutional practice guidelines.
• As determined at the discretion of the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study.

Exclusion Criteria

• Active infection requiring systemic therapy within 7 days of enrollment.
• Uncontrolled HIV/AIDS or active viral hepatitis (e.g., HBV, HCV)
• Any ongoing significant toxicity resulting from prior anticancer therapy that, as determined by the treating provider, has the potential to interfere with the safety or efficacy assessment of this investigational regimen.
• ECOG performance status score >2
• Clinically significant lung, heart, or autoimmune disease
• Life expectancy <12 weeks
• Prior solid organ or bone marrow transplant
• Antibiotics, vaccines or other type of surgery within 4 weeks prior intervention treatment
• Pregnant or nursing
• Any prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of this investigational regimen, as determined by the treating provider.
• Any mental or medical condition that prevents the patient from giving informed consent or participating in the trial.
• Another major comorbidity, as determined by treating provider.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	Docetaxel	OncoChoiceTM results will provide ranking of drug effectiveness (e.g., active, inactive, moderately active drug) across a list of pre-selected chemotherapies (FDA-approved NSCLC treatments
Single Arm	Paclitaxel	OncoChoiceTM results will provide ranking of drug effectiveness (e.g., active, inactive, moderately active drug) across a list of pre-selected chemotherapies (FDA-approved NSCLC treatments
Single Arm	Gemcitabine	OncoChoiceTM results will provide ranking of drug effectiveness (e.g., active, inactive, moderately active drug) across a list of pre-selected chemotherapies (FDA-approved NSCLC treatments
Single Arm	Pemetrexed	OncoChoiceTM results will provide ranking of drug effectiveness (e.g., active, inactive, moderately active drug) across a list of pre-selected chemotherapies (FDA-approved NSCLC treatments
Single Arm	Vinorelbine	OncoChoiceTM results will provide ranking of drug effectiveness (e.g., active, inactive, moderately active drug) across a list of pre-selected chemotherapies (FDA-approved NSCLC treatments

Primary Outcome Measures

Name	Time	Method
To 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	Every 6-8 weeks through study completion, an average of 2 years	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).

Secondary Outcome Measures

Name	Time	Method
To estimate the 6-month progression-free survival (PFS) in 2L and beyond NSCLC patients who receive OncoChoice-informed chemotherapy regimen	Day 1 of treatment through study completion, an average of 2 years	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.
To estimate the overall survival (OS) in 2L and beyond NSCLC patients who receive OncoChoice-informed chemotherapy regimen	Day 1 of treatment through study completion, an average of 2 years	OS is defined as the time from D1 of treatment to death as a result of any cause.
To describe changes in health-related quality of life (HRQoL) over the course of treatment following OncoChoice-informed regimen vs. standard chemotherapy	Screening through study completion, an average of 2 years	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

Trial Locations

Locations (1)

University of Illinois Cancer Center; 🇺🇸 Chicago, Illinois, United States