NSCLCLUNG-05NCT06576635
LUNG-05: Investigating Chemotherapy Effectiveness for Non-Small Cell Lung Cancer (NSCLC) Metastatic Patients
A study testing Docetaxel, Paclitaxel and Gemcitabine in people with NSCLC, run by University of Illinois Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC
- What is being tested?
- Docetaxel, Paclitaxel and Gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Dec 2024to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Illinois Cancer Center
Chicago, Illinois, 60612
Frank Weinberg, MD, PhD, 312-413-7494, fweinb1@uic.edu
Ruihong Yin, (312) 355-2545, ryin6@uic.edu
About this study
Official title: 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.
Read the 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
- Being tested
- Docetaxel, Paclitaxel, Gemcitabine, Pemetrexed, Vinorelbine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
75 mg/m2 IV over 1-hour Day 1 of each 21-day cycle
PaclitaxelDrug
135 mg/m2 IV over 3 hours Day 1 of each 21-day cycle
GemcitabineDrug
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
PemetrexedDrug
500 mg/m2 IV over 10 minutes on Day 1 of each 21-day cycle
VinorelbineDrug
30 mg/m2 IV through a weekly injection over 6-19 minutes on Days 1, 8, and 15 of each 21-day cycle
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Docetaxel; Drug: Paclitaxel; Drug: Gemcitabine; Drug: Pemetrexed; Drug: Vinorelbine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
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.
Measured: 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.
Measured: 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
Measured: Screening through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start16 Dec 2024
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frank Weinberg, University of Illinois Chicago
- Investigators
- Frank Weinberg, MD, PhD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06576635
- Sponsor's protocol ID
- 2024-0301
- Acronym
- LUNG-05
- Status last verified
- Jan 2026
- First submitted
- 26 Aug 2024
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LUNG-05: Investigating Chemotherapy Effectiveness for NSCLC Metastatic Patients
- ClinicalTrials.gov ID
- NCT06576635
- Acronym / sponsor ID
- LUNG-05 / 2024-0301
- Conditions
- NSCLC
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- 16 Dec 2024 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 29 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Other | Drug: Docetaxel, Drug: Paclitaxel, Drug: Gemcitabine, Drug: Pemetrexed, Drug: VinorelbineOncoChoiceTM 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Docetaxel75 mg/m2 IV over 1-hour Day 1 of each 21-day cycle | Drug | Single Arm |
| Paclitaxel135 mg/m2 IV over 3 hours Day 1 of each 21-day cycle | Drug | Single Arm |
| Gemcitabine1000 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 | Single Arm |
| Pemetrexed500 mg/m2 IV over 10 minutes on Day 1 of each 21-day cycle | Drug | Single Arm |
| Vinorelbine30 mg/m2 IV through a weekly injection over 6-19 minutes on Days 1, 8, and 15 of each 21-day cycle | Drug | Single Arm |
Primary outcome
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).
3 secondary outcomes
To estimate the 6-month progression-free survival (PFS) in 2L and beyond NSCLC patients who receive OncoChoice-informed chemotherapy regimen
Time frame: 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
Time frame: 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
Time frame: Screening through study completion, an average of 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Frank Weinberg, MD, PhD principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Docetaxel, Paclitaxel and Gemcitabine in people with NSCLC, run by University of Illinois Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Frank Weinberg, MD, PhD ((312) 413-7494, fweinb1@uic.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.