LUNG-05: Chemotherapy for Metastatic NSCLC

This study, LUNG-05, is investigating how effective different chemotherapy drugs are for people with advanced non-small cell lung cancer (NSCLC) that has spread (metastatic). You might receive treatments like Docetaxel, Paclitaxel, Gemcitabine, Pemetrexed, or Vinorelbine. To join, you must be at least 18 years old, have advanced NSCLC confirmed by a biopsy, and have already received at least one prior treatment for your cancer. The study aims to see how many patients respond to the treatment, which will be measured by your doctor every 6-8 weeks for about two years. The study is currently unclear about its recruitment status and plans to enroll 29 participants.

Study design
This is a single-arm pilot study, meaning all 29 participants will receive the study treatment. It is not specified if it is blinded.
What's involved
You would undergo a biopsy or fluid removal as part of standard care. Additional testing may be required by your doctor, and treatment responsiveness will be tested using biosamples.
Compensation
Not stated in the trial record.
Follow-up
Your response to treatment will be measured every 6-8 weeks through study completion, which is an average of two years.

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NCT06576635

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

Recruiting
NAAges 18+InterventionalTreatment
University of Illinois at Chicago
~29 participants
Updated 2026-01-20 on ClinicalTrials.gov
What's tested:DocetaxelPaclitaxelGemcitabinePemetrexedVinorelbine

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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
Measured over Every 6-8 weeks through study completion, an average of 2 years
NSCLC
1 sites across 1 states
Illinois1
  • Frank Weinberg, MD, PhD · PRINCIPAL_INVESTIGATOR · University of Illinois at Chicago

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Eligibility criteria

Inclusion

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

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.
  • 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 treatmentEvery 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).