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

NCT ID: NCT06576635

Last Updated: 2025-11-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-16
• Study Completion Date: 2026-09-30

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.

Conditions

NSCLC

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: OTHER

Docetaxel

Intervention Type: DRUG

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

Paclitaxel

Intervention Type: DRUG

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

Gemcitabine

Intervention Type: 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

Pemetrexed

Intervention Type: DRUG

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

Vinorelbine

Intervention Type: DRUG

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

Interventions

Docetaxel

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

Intervention Type: DRUG

Paclitaxel

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

Intervention Type: 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

Intervention Type: DRUG

Pemetrexed

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

Intervention Type: 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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Illinois at Chicago

OTHER

Sponsor Role: lead

Responsible Party

Frank Weinberg

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Frank Weinberg, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Chicago

Locations

University of Illinois Cancer Center

Chicago, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Frank Weinberg, MD, PhD

Role: CONTACT

Phone: (312) 413-7494

Email: fweinb1@uic.edu

Ruihong Yin

Role: CONTACT

Phone: (312) 355-2545

Email: ryin6@uic.edu

Facility Contacts

Frank Weinberg, MD, PhD

Role: primary

Ruihong Yin

Role: backup

Other Identifiers

2024-0301

Identifier Type: -

Identifier Source: org_study_id