OncoChoice-guided chemotherapy for metastatic non-small cell lung cancer (second-line and beyond)

LUNG-05: Investigating Chemotherapy Effectiveness for NSCLC Metastatic Patients

This pilot will try using OncoChoice testing to help pick chemotherapy for adults with metastatic NSCLC who need second-line or later treatment.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 29 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Illinois at Chicago (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Chicago, Illinois)
• Trial ID: NCT06576635 on ClinicalTrials.gov

What this trial studies

This is a single-arm, Simon two-stage pilot enrolling adults with metastatic (primarily Stage IV) NSCLC who have received at least one prior systemic therapy. After consent, patients undergo tumor biopsy or malignant fluid collection and samples are sent within 24 hours to OncoOptima for OncoChoice drug-response testing. Treating physicians use OncoChoice results alongside NCCN dosing guidelines to select FDA-approved chemotherapy agents such as docetaxel, paclitaxel, gemcitabine, pemetrexed, or vinorelbine. Patients receive standard-of-care chemotherapy with additional testing or therapies allowed at the treating provider's discretion. The study will monitor treatment response and safety to determine whether the OncoChoice-guided approach merits further study.

Who should consider this trial

Good fit: Adults (≥18) with histologically confirmed metastatic NSCLC who have had at least one prior systemic therapy, are candidates for second-line or later chemotherapy, have ECOG ≤2, and adequate organ function are ideal candidates.

Not a fit: Patients with ECOG >2, inadequate organ function, inability to undergo biopsy or fluid collection, or who are not candidates for small-molecule chemotherapy are unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, the approach could help clinicians choose chemotherapy that is more likely to work for individual patients, potentially improving response and avoiding ineffective treatments.

How similar studies have performed: Similar ex vivo drug-response and genomic-guided approaches have shown mixed results and remain experimental, so this pilot aims to see if OncoChoice adds predictive value beyond standard guidelines.

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.
* 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 this trial is running

Chicago, Illinois

• University of Illinois Cancer Center — Chicago, Illinois, United States (RECRUITING)

Study contacts

• Principal investigator: Frank Weinberg, MD, PhD — University of Illinois at Chicago
• Study coordinator: Frank Weinberg, MD, PhD

Conditions: NSCLC