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

LUNG-05: Investigating Chemotherapy Effectiveness for NSCLC Metastatic Patients

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.

Study Overview

• Status: Recruiting
• Conditions: NSCLC
• Intervention / Treatment: Drug: Docetaxel; Drug: Paclitaxel; Drug: Gemcitabine; Drug: Pemetrexed; Drug: Vinorelbine

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 Type: Interventional
• Enrollment (Estimated): 29
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Frank Weinberg, MD, PhD; Phone Number: (312) 413-7494; Email: fweinb1@uic.edu
• Study Contact Backup: Name: Ruihong Yin; Phone Number: (312) 355-2545; Email: ryin6@uic.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • University of Illinois Cancer Center
      • Contact: Ruihong Yin; Phone Number: (312) 355-2545; Email: ryin6@uic.edu
      • Contact: Frank Weinberg, MD, PhD; Phone Number: 312-413-7494; Email: fweinb1@uic.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.
• Patients have received at least 1 prior line of systemic therapy for Stage IV NSCLC, including but not limited to targeted therapy, and are currently candidates for 2L or later SOC chemotherapy. Exceptionally, patients with Stage III NSCLC who have received at least 1 line of systemic therapy may be considered eligible, pending principal investigator approval.
• 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, live 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Single Arm; 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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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).	Every 6-8 weeks through study completion, an average of 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	Screening through study completion, an average of 2 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
To characterize changes in blood circulating immune cell populations before and after OncoChoice-based treatment by utilizing spectral flow analysis	Circulating blood immune cell populations will be determined by spectral flow analysis	Day 1 of treatment through study completion, an average of 2 years
To explore blood circulating cytokine levels before and after OncoChoice based treatment by utilizing bulk cytokine analysis (Bruker Cellular Analysis).	Circulating blood cytokine levels determined utilizing bulk cytokine analysis (Bruker Cellular Analysis)	Day 1 of treatment through study completion, an average of 2 years

Collaborators and Investigators

• Sponsor: University of Illinois at Chicago
• Investigators: Principal Investigator: Frank Weinberg, MD, PhD, University of Illinois at Chicago

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: August 26, 2024
• First Submitted That Met QC Criteria: August 26, 2024
• First Posted (Actual): August 29, 2024

Study Record Updates

• Last Update Posted (Actual): January 20, 2026
• Last Update Submitted That Met QC Criteria: January 15, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Amino Acids, Peptides, and Proteins; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Hydrocarbons; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Alkaloids; Indoles; Guanine; Hypoxanthines; Purinones; Purines; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic; Taxoids; Cyclodecanes; Diterpenes; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Indolizidines; Indolizines; Docetaxel; Vinorelbine; Pemetrexed; Gemcitabine; Paclitaxel
• Other Study ID Numbers: 2024-0301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No