This trial is a prospective, observational study of non-small cell lung cancer that aims to evaluate the feasibility, preliminary efficacy and safety of patient-derived tumor-like cell cluster model in guiding the precision treatment strategy.
Age: ≥18 years and ≤80 years;
Non-small cell lung cancer diagnosed by pathology (including histology or cytology);
Having measurable lesions (according to RECIST 1.1 criteria, the long diameter of CT scan of tumour lesion is ≥10mm, the short diameter of CT scan of lymph node lesion is ≥15mm, the thickness of scanning layer is not more than 5mm, and the measurable lesion has not received local treatment such as radiotherapy, cryotherapy, etc.);
ECOG PS: 0-2 points;
Currently participating in an interventional clinical study treatment, or have received another investigational drug or investigational device within 4 weeks prior to the first dose;
Have received a proprietary medicine with an anti-tumor indication or an immunomodulatory drug (thymidine, interferon, interleukin, etc.) within 2 weeks prior to the first dose, or have received major surgical treatment within 3 weeks prior to the first dose;
Presence of active hemoptysis, active diverticulitis, abdominal abscess, gastrointestinal obstruction and peritoneal metastases requiring clinical intervention;
Known or screening test findings of active central nervous system (CNS) metastases and/or carcinomatous meningitis;
Non-small cell lung cancer diagnosed by pathology (including histology or cytology)
Cohort
Prospective
PTC predicts the response to drug therapy in lung cancer patients
Diagnostic testa Prospective, Observational Study
Concordance Rate between PTC drug-sensitivity results and clinical response
Clinical response is evaluated according to RECIST 1.1 criteria. Concordance rate is defined as the percentage of participants whose clinical response (Complete Response or Partial Response) matches the predicted sensitivity by the PTC assay.
Progression free survival
The progression free survival between PTC drug-testing high group with PTC drug-testing low group
Difference in Proportion of Tumor-Infiltrating Immune Cell Subsets (e.g., T cells, B cells, Macrophages).
Evaluated by single-cell RNA sequencing (scRNA-seq) or transcriptomic analysis on samples (pleural effusion, biopsy, etc.). Data will be reported as the percentage of specific immune cell types (e.g., CD4+, CD8+ T cells, Tregs, M1/M2 macrophages) relative to total cells, comparing the PTC drug-testing high group with the low group.
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