Clinical trial NCT06576635: LUNG-05: Investigating Chemotherapy Effectiveness for Non-Small Cell Lung Cancer (NSCLC) Metastatic Patients
Official title: LUNG-05: Investigating Chemotherapy Effectiveness for NSCLC Metastatic Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: NSCLC
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2024-08-29
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

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.
* Patient has received at least 1 prior line of systemic therapy for Stage IV NSCLC (including but not limited to targeted therapy and are now only considering SOC chemotherapy for 2L and beyond).
* 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, 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.

Primary outcomes:
measure: Objective Response Rate (ORR): ORR is defined as number of patients with complete response (CR)
timeFrame: 8 weeks
measure: Objective Response Rate (ORR): ORR is defined as number of patients with partial response (PR)
timeFrame: 8 weeks
Secondary outcomes:
measure: Number of participants that have Progression Free Survival (PFS) rate
timeFrame: 8 weeks
measure: Number of participants that have an overall survival (OS) rate
timeFrame: 1 month
measure: Number of participants that have Health-related Quality of Life (HRQoL) issues
timeFrame: Screening
measure: Number of participants that have Health-related Quality of Life (HRQoL) issues
timeFrame: 8 weeks
measure: Number of participants that have Health-related Quality of Life (HRQoL) issues
timeFrame: 8 weeks
measure: Number of participants that have Health-related Quality of Life (HRQoL) issues
timeFrame: 30 days after last dose
measure: Number of participants that have Health-related Quality of Life (HRQoL) issues
timeFrame: 3 months after last dose
measure: Number of participants that have Health-related Quality of Life (HRQoL) issues
timeFrame: 6 months after last dose
Other outcomes:
Locations:
Study officials:
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