Recruiting

OncoChoice-informed Chemotherapy

Sponsor:

University of Illinois at Chicago

Code:

NCT06576635

Conditions

NSCLC

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Docetaxel

Paclitaxel

Gemcitabine

Pemetrexed

Vinorelbine

Study Details

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

Study ID

NCT06576635

Start date

Dec 16, 2024

Status verified date

Jan, 2026

Completion date

Sep, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

29 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: 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

Interventions

Docetaxel

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

Paclitaxel

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

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

Pemetrexed

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

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 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 ]

Central Contacts and Locations

Central contacts

Frank Weinberg, MD, PhD

(312) 413-7494fweinb1@uic.edu

Ruihong Yin

(312) 355-2545ryin6@uic.edu

Locations

University of Illinois Cancer Center

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Frank Weinberg, MD, PhD

312-413-7494fweinb1@uic.edu

Ruihong Yin

(312) 355-2545ryin6@uic.edu

More Information

Sponsor

University of Illinois at Chicago

Last update posted

Jan 20, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Illinois at Chicago on 2026-01-20.