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 @ 11:57 PM
Ignite Modification Date:
2025-12-24 @ 11:57 PM
NCT ID:
NCT06604351
Eligibility Criteria:
Inclusion Criteria:
* Understand the requirements and contents of the clinical trial and provide a signed and dated informed consent form.
* Age≥18 years and≤80 years.
* Histologically or cytologically confirmed and documented locally advanced or metastatic non-small cell lung cancer (NSCLC) without prior systemic therapy and EGFR-sensitive mutations (19del, L858R and T790M).
* Presence of a palliative treatment lesion in the central airway that is amenable to ablation, endoscopically assessed to be≥1/3 obstruction, such as primary or metastatic malignancy to the trachea, main bronchi, intermediate bronchi, or segmental bronchi. corresponding respiratory symptoms or obstructive pneumonia is permission to be included.
* Eastern Cooperative Oncology Group (ECOG) ： 0-2.
* Predicted survival ≥ 12 weeks.
* Adequate bone marrow hematopoiesis and organ function (cardiac function, hepatic, and renal function).
* Presence of measurable lesions according to RECIST 1.1 criteria.
* Subjects with stable brain metastases may be included in the study.
Exclusion Criteria:
* Histological diagnosis of small cell, large cell lung cancer; mixed tumors will be classified based on the primary cell type; if the primary component is small cell, large cell, or neuroendocrine carcinoma, the subject will not be eligible for enrollment; however, mixed adenocarcinoma-squamous cell carcinoma is acceptable. Subjects with driver gene mutations are generally not eligible for enrollment.
* Malignant central airway obstruction with acute dyspnea or severe life-threatening symptoms of malignant airway stenosis, or assessed by the investigator to be unable to tolerate subsequent treatment; extrinsic airway compression; large pleural effusion, severe coughing, massive hemoptysis, dyspnea, or inability to cooperate; severely impaired lung function with a maximal voluntary ventilation (MVV) \< 39% or inability to ambulate.
* Prior systemic therapy for locally or metastatic disease.
* Uncorrectable coagulation disorders, severe bleeding tendencies, platelet count \< 50 \*10\^9/L, or severe coagulation dysfunction.
* Presence of symptomatic brain metastases.
* Known severe hypersensitivity to anti-PD-1 monoclonal antibodies or similar drugs (allergic reactions with CTCAE≥ grade 3 toxicity).
* Subjects with persistent or active infection, including but not limited to hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV).
* Any concurrent malignancy other than basal cell carcinoma or cervical carcinoma in situ. (Patients with a history of malignant tumors but with no evidence of disease for≥ 3 years may be included ).
* Women who are breastfeeding or pregnant.
* Other conditions assessed by the investigator to be unsuitable for participation in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06604351
Study Brief:
Protocol Section:
NCT06604351