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 @ 7:44 PM
Ignite Modification Date:
2025-12-24 @ 7:44 PM
NCT ID:
NCT06127303
Eligibility Criteria:
Inclusion Criteria:
* Voluntary participation and written informed consent;
* histologically or cytologically confirmed advanced metastatic (stage IV) non-small cell lung cancer;
* Patients with negative driver genes who develop oligoprogression after receiving standard first-line therapy. The oligoprogression is defined as: 1-5 metastatic lesions, and no more than 3 organs;
* Age 18-75 years old; ECOG PS: 0-1; The expected survival is more than 3 months;
* At least one measurable lesion;
* Patients were willing to provide adequate blood and tissue samples；
* Patients had adequate hematologic, renal, and liver function;
* International normalised ratio (INR) ≤1.5 and partial thromboplastin time (PTT or aPTT) ≤1.5 x ULN within 7 days prior to study treatment;
* The woman patients of childbearing age who must agree to take contraceptive methods during the research;
* The man patients who must agree to take contraceptive methods during the research and within another 6 months after it.
Exclusion Criteria:
* cytologically or histologically confirmed combination with small cell lung cancer component or sarcomatoid element;
* Previously received targeted therapy for advanced NSCLC (including osimertinib, erlotinib, crizotinib, etc);
* Had undergone major surgical operations or had not fully recovered from previous operations within 3 weeks before enrollment;
* Known active nervous system (CNS) metastases and/or carcinomatous meningitis;
* Spinal cord compression for which operation and/or radical radiotherapy has not been given, or no clinical evidence of stable disease for ≥4 weeks prior to enrollment after treatment for previously diagnosed spinal cord compression;
* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage; patients with stable symptoms after drainage can be enrolled;
* History of idiopathic pulmonary fibrosis, organized pneumonia (e.g., obliterating bronchiolitis), drug induced pneumonia, idiopathic pneumonia or evidence of active pneumonia during chest CT scanning for screening;
* Clinically uncontrolled active infection, including but not limited to acute pneumonia;
* Uncontrollable major epileptic seizure or superior vena cava syndrome;
* Previous or current co-occurrence of other malignancies (excluding controllable non-melanoma basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the breast or cervix, superficial bladder cancer, or other carcinoma in situ);
* Known hepatic diseases of clinical significance, including active viral hepatitis, alcoholic hepatitis or other hepatitis, liver cirrhosis, fatty liver, hereditary liver disease;
* Active tuberculosis (TB), receiving anti-tuberculosis therapy currently or within one year prior to screening;
* Use of systemic immunosuppressive therapy for any active autoimmune disease within two years prior to Day 1 of the 1st cycle;
* Vaccination of live-virus vaccine within 30 days after the start of planned treatment; Inactivated seasonal influenza vaccine was permitted;
* Patients has HIV-positive;
* Patients judged by the investigator to be inappropriate as a subject of this study.
* History of severe allergic, quasi-allergic, or other hypersensitive reactions to chimeric or humanized antibodies or fusion proteins;
* Known allergy to biological drugs produced from Chinese hamster ovary cells, or to citrate monohydrate, sodium citrate dihydrate, mannitol, polysorbate (components of the study drug);
* Patients who have previously received allogeneic stem cells or parenchymal organ transplants.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06127303
Study Brief:
Protocol Section:
NCT06127303