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:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2025-12-25 @ 2:31 AM
NCT ID:
NCT07288034
Eligibility Criteria:
Inclusion Criteria:
* Documented informed consent of the participant and/or legally authorized representative. (Adult patients lacking capacity to consent may participate if they have a caretaker that could ensure compliance.)
* Participants must have either A) HopeSeq or Tempus molecular testing results reported within 3 months prior to enrollment or currently in process OR B) archival or new biopsy tissue available (to be sent to Tempus). Acceptable sample types include: two formalin-fixed paraffin-embedded (FFPE) tissue core biopsies, or two 25um sections of 5-10mm\^2 tissue, or 15-20 unstained slides at 10um thickness (a minimum of 10 unstained slides must be provided)
* Agreement to blood collection for ctDNA research
* Age: ≥ 18 years
* Eastern Cooperative Oncology Group (ECOG) ≤ 2
* Histologically confirmed stage IIIB or IV NSCLC
* Absence of sensitizing EGFR mutation or ALK/ROS1 alteration
* Scheduled to begin treatment with a Food and Drug Administration (FDA) approved PD1/PDL1 antibody with or without chemotherapy. Participants who have already started treatment with anti-PD1/PDL1 in this setting may enroll if they have only received up to 4 cycles of treatment so far. Patients who have received PD1/PDL1 antibody for early-stage NSCLC are allowed to enroll if they completed the therapy at least 6 months before starting trial therapy
* Measurable disease by RECIST version (v) 1.1
* Absolute neutrophil count (ANC) ≥ 1,500/mm\^3
* NOTE: Growth factor is not permitted within 14 days of ANC assessment
* Platelets ≥ 100,000/mm\^3
* NOTE: Platelet transfusions are not permitted within 14 days of platelet assessment
* Hemoglobin ≥ 9g/dL
* NOTE: Red blood cell transfusions are not permitted within 14 days of hemoglobin assessment
* Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
* Aspartate aminotransferase (AST) ≤ 3.0 x ULN (5 x ULN allowed if liver metastases)
* Alanine aminotransferase (ALT) ≤ 3.0 x ULN (5 x ULN allowed if liver metastases)
* Creatinine clearance of ≥ 50 mL/min per the Cockcroft-Gault formula
* If seropositive for HIV, hepatitis C virus (HCV), or hepatitis B virus (HBV), nucleic acid quantitation must be performed. Viral load must be undetectable
* HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
* Women of childbearing potential (WOCBP): negative urine or serum pregnancy test
* If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
* Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 3 months after the last dose of protocol therapy
* Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only)
* PART II: Documented informed consent (for Part II) of the participant and/or legally authorized representative.
* Assent, when appropriate, will be obtained per institutional guidelines
* PART II: ECOG ≤ 2
* PART II: Fully recovered from the acute toxic effects (except alopecia) to ≤ grade 1 to prior anti-cancer therapy
* PART II: ANC ≥ 1,500/mm\^3
* NOTE: Growth factor is not permitted within 14 days of ANC assessment
* PART II: Platelets ≥ 100,000/mm\^3
* NOTE: Platelet transfusions are not permitted within 14 days of platelet assessment
* PART II: Hemoglobin ≥ 9g/dL
* NOTE: Red blood cell transfusions are not permitted within 14 days of hemoglobin assessment
* PART II: Total bilirubin ≤ 1.5 x ULN
* PART II: AST ≤ 3.0 x ULN (5 x ULN allowed if liver metastases)
* PART II: ALT ≤ 3.0 x ULN (5 x ULN allowed if liver metastases)
* PART II: Creatinine clearance of ≥ 50 mL/min per the Cockcroft-Gault formula
Exclusion Criteria:
* Surgical intervention within 4 weeks prior to study treatment, except for minor procedures such as port placement
* Patients with a condition requiring systemic treatment with corticosteroids (\> 10 mg daily prednisone equivalent) within 7 days or another immunosuppressive medication within 30 days of the first dose of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses ≤ 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease
* Radiation therapy within 7 days prior to day 1 of protocol therapy
* Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke or myocardial infarction within 6 months of enrollment, unstable angina, congestive heart failure (New York Heart Association \[NYHA class\] ≥ III), or serious uncontrolled cardiac arrhythmia requiring medication
* Active autoimmune disease or history of autoimmune disease that required systemic treatment within 2 years before starting treatment, i.e., with use of disease-modifying agents or immunosuppressive drugs
* Symptomatic central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for individuals who have 1) previously-treated CNS metastases, are asymptomatic, and have had no requirement for steroid medication for 1 week prior to the first dose of study drug and have completed radiation 2 weeks prior to the first dose of study drug OR 2) untreated brain metastases that are asymptomatic and stable
* Prior history of interstitial lung disease (ILD) or non-infectious pneumonitis requiring high-dose glucocorticoids
* Active infection requiring antibiotics
* Other active malignancy. Patients with concurrent malignancy other than non-melanoma skin cancer are not eligible for this trial due to potential confounding of the ctDNA results
* Females only: Pregnant or breastfeeding
* PART II: Surgical intervention within 4 weeks prior to study treatment, except for minor procedures such as port placement
* PART II: Radiation therapy within 7 days prior to day 1 of protocol therapy
* PART II ARM A ONLY: Patients with a condition requiring systemic treatment with corticosteroids (\> 10 mg daily prednisone equivalent) within 7 days or another immunosuppressive medication within 30 days of the first dose of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses ≤ 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease
* PART II ARM A ONLY: Patients with prior history of cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) treatment
* PART II ARM B ONLY: Patients with prior history of KRAS G12C inhibitors
* PART II: Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke or myocardial infarction within 6 months of enrollment, unstable angina, congestive heart failure (New York Heart Association class ≥ III), or serious uncontrolled cardiac arrhythmia requiring medication
* PART II ARM A ONLY: Active autoimmune disease or history of autoimmune disease that required systemic treatment within 2 years before starting treatment, i.e., with use of disease-modifying agents or immunosuppressive drugs
* PART II ARM B ONLY: Grade ≥ 2 proteinuria as demonstrated by ≥ 2+ protein and ≥ 1.0 g of protein with 24-hour urine collection (patients found to have ≥ 2+ protein on dipstick urinalysis must have 24-hour urine collection and demonstrate \< 1g of protein in 24 hours in order to be eligible for treatment)
* PART II: Clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for individuals who have 1) previously-treated CNS metastases, are asymptomatic, and have had no requirement for steroid medication for 1 week prior to the first dose of study drug and have completed radiation 2 weeks prior to the first dose of study drug OR 2) untreated brain metastases that are asymptomatic and stable
* PART II: Clinically significant uncontrolled illness
* PART II: Active infection requiring antibiotics
* PART II: Other active malignancy
* PART II FEMALES ONLY: Pregnant or breastfeeding
* PART II: Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07288034
Study Brief:
Protocol Section:
NCT07288034