Non-small cell lung cancer
Conditions
Sponsors
Second Affiliated Hospital of Army Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Aged 18 to 75 years old (calculated as of the date of signing the informed consent form); (2) Histopathological diagnosis of non-small cell lung cancer; (3) After receiving 2-3 rounds of systemic treatment, the disease progressed as assessed by imaging (according to the RECIST 1.1 criteria, disease progression is defined as an increase in the sum of target lesion diameters by >=20% from the lowest value and an absolute increase of >=5mm, or the appearance of new lesions), and subsequent chemotherapy is planned to be administered; (4) According to the Response Evaluation Criteria in Solid Tumors (RECIST version 1.1), at least one lesion (which can be from a single lesion source or a combination of multiple lesions, including but not limited to malignant pleural and peritoneal effusions) that has not undergone radiotherapy or other local therapies and for which tumor tissue is available should be used for organoid establishment; (5) Hematological examination (results within 7 days prior to the first dose are required for confirmation): a) Good bone marrow reserve function: absolute neutrophil count (ANC) >=1.5 x 10^9/L, platelet count (PLT) >=90 x 10^9/L, and hemoglobin (HB) >=90 g/L. b) Good coagulation function: International Normalized Ratio (INR) or Prothrombin Time (PT) 3 months; (9) Individuals with reproductive capacity (including male and female patients) agree to adopt effective contraceptive measures approved by the researcher during the trial period and within 3 months after the trial ends (such as intrauterine devices, contraceptive pills, or condoms). For female patients with reproductive capacity, the serum human chorionic gonadotropin test result within 72 hours before study enrollment should be negative; (10) Patients voluntarily join this study, sign the Informed Consent Form (ICF), demonstrate good compliance, and cooperate with follow-up visits.
Exclusion criteria
Exclusion criteria: (1) Patients with extremely weakened overall condition and unable to tolerate bronchoscopy; (2) Patients with acute suppurative inflammation of the respiratory tract accompanied by high fever, acute asthma attack, and ongoing hemoptysis; (3) History of interstitial lung disease, non-infectious pneumonia, or uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung disease, etc; (4) Pathological diagnosis confirmed the presence of small cell lung cancer components; (5) Patients with active leptomeningeal disease or brain metastasis; (6) Diagnosed with malignant diseases other than NSCLC within 5 years prior to the first administration (excluding skin basal cell carcinoma, squamous cell carcinoma of the skin, and/or carcinoma in situ that have undergone radical resection); (7) Prior to enrollment, there was still an acute toxicity reaction of grade >=2 (CTCAE 5.0, excluding alopecia) caused by previous anti-tumor treatment (surgery, radiotherapy, chemotherapy, targeted therapy, or immunotherapy); (8) Known allogeneic organ transplantation (excluding corneal transplantation) or allogeneic hematopoietic stem cell transplantation; (9) Concurrent cardiac dysfunction, manifested as any of the following conditions: uncontrolled pericardial effusion; severe arrhythmia; unstable angina; left ventricular ejection fraction (LVEF) =470ms in females, QTc >=450ms in males); (10) Patients with active infections, including active tuberculosis (clinical diagnosis includes clinical history, physical examination, and imaging findings, as well as TB testing conducted according to local medical practice), human immunodeficiency virus infection (HIV antibody positive), hepatitis B (known HBV surface antigen (HBsAg) positive and HBV DNA >= 10^3 copies/mL), hepatitis C (known HCV antibody positive and HCV-RNA >= 10^4 copies/mL); patients with hepatitis B and C whose conditions have been controlled by antiviral treatment can participate in this study; (11) The presence of any severe or uncontrollable systemic disease; (12) Patients with neurological or psychiatric disorders who are unable or unwilling to cooperate; (13) Female patients who are pregnant or breastfeeding; (14) Subjects who have received any other investigational drug treatment or participated in other clinical trials within 28 days; (15) Patients deemed unsuitable for inclusion by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactZhu Bo
Second Affiliated Hospital of Army Medical University
Outcome results
None listed