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

NCT06576635 | Recruiting DMC

• 1 other identifier: 2024-0301
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

NSCLC

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• 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

• 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

Other Outcomes (2)

• To characterize changes in blood circulating immune cell populations before and after OncoChoice-based treatment by utilizing 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).

  Day 1 of treatment through study completion, an average of 2 years

Study Arms (1)

Single Arm

OTHER

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; Drug: Paclitaxel; Drug: Gemcitabine; Drug: Pemetrexed; Drug: Vinorelbine

Interventions

Docetaxel DRUG

75 mg/m2 IV over 1-hour Day 1 of each 21-day cycle

Single Arm

Paclitaxel DRUG

135 mg/m2 IV over 3 hours Day 1 of each 21-day cycle

Single Arm

Gemcitabine DRUG

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

Single Arm

Pemetrexed DRUG

500 mg/m2 IV over 10 minutes on Day 1 of each 21-day cycle

Single Arm

Vinorelbine DRUG

30 mg/m2 IV through a weekly injection over 6-19 minutes on Days 1, 8, and 15 of each 21-day cycle

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

University of Illinois Cancer Center

Chicago, Illinois, 60612, United States

RECRUITING

MeSH Terms

Interventions

Docetaxel; Paclitaxel; Gemcitabine; Pemetrexed; Vinorelbine

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines

Study Officials

• Frank Weinberg, MD, PhD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Frank Weinberg, MD, PhD

CONTACT

(312) 413-7494; fweinb1@uic.edu

Ruihong Yin

CONTACT

(312) 355-2545; ryin6@uic.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: August 29, 2024
• Study Start: December 16, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: January 20, 2026

Record last verified: 2026-01

Locations

US (1)