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 @ 12:23 PM
Ignite Modification Date:
2025-12-24 @ 12:23 PM
NCT ID:
NCT06418061
Eligibility Criteria:
Inclusion Criteria:
Subjects Should have been previously treated with a third-generation EGFR TKI with disease progression. Subjects with positive other driver genes or METex14 mutations are required to undergo targeted therapy and disease progression.
Exclusion Criteria:
Received live vaccines within 4 weeks prior to first administration of the study drug or plan on receiving any live vaccine during the study.Patients are allowed to receive inactivated vaccines.
Uncontrolled diseases including:
* Infection requiring systemic antibiotics, antivirals or antifungals within 2 weeks prior to first dose of the study drug（ antiviral medication for hepatitis B and hepatitis C infection that are compliant with the protocol were allowed）;
* Known human immunodeficiency virus (HIV) infection, or HIV positive (HIV 1/2 Ab positive);
* Acute or chronic active hepatitis B (HbsAg positive and/or HbcAb positive with HBV DNA titer ≥ 104 copies/mL or ≥ 2000 IU/mL or higher than lower limit of detection) or C (HCV Ab positive with HCV RNA titer \> 103 copies/mL or higher than lower limit of detection);
* Active COVID-19 infection with obvious symptoms requiring treatment or hospitalization, such as pyrexia, dyspnea, nausea, vomiting, diarrhea, etc.;
* Active tuberculosis infection, or still on anti-tuberculosis therapy or received anti tuberculosis therapy within 1 year prior to first administration of the study drug;
* Active syphilis infection or latent syphilis requiring treatment;
* Symptomatic congestive heart failure Grade II-IV (New York Heart Association \[NYHA\]), symptomatic or uncontrolled arrhythmias, QTc interval \> 480 ms or personal or family history of congenital long/short QT syndrome;
* Hypertension that does not receive standardized therapy or still uncontrollable hypertension (SBP ≥ 160 mmHg or DBP ≥ 100 mmHg); Any history of life-threatening hemorrhage, or hemorrhage requiring (including but not limited to gastrointestinal bleeding, hemoptysis, etc) blood transfusion, endoscopy, or surgery, within 3 months prior to the first administration of study drug;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06418061
Study Brief:
Protocol Section:
NCT06418061