NCT06576635 · University of Illinois at Chicago
LUNG-05: Investigating Chemotherapy Effectiveness for Non-Small Cell Lung Cancer (NSCLC) Metastatic Patients
(LUNG-05)
What this study is about
This is a Single treatment group$1, 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.
View original scientific 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.
Interventions
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
Primary outcome measures
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
Time frame: 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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Chicago, Illinois
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 20, 2026 · Source of record for eligibility and locations