Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-24 @ 10:22 PM
NCT ID:
NCT06576635
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06576635
Study Brief:
Protocol Section:
NCT06576635