Neuroendocrine Transformation in RB1/TP53 Inactivated NSCLC

Prior treatment

• Patients who require long-term treatment with cortisol or immunosuppressants;

Other illness

• Symptomatic interstitial lung disease or active infection/non infectious pneumonia;
• History of other malignant tumors;
• Physical examination or clinical trial findings that researchers believe may interfere with the results or increase the risk of treatment complications for patients, or other uncontrollable diseases
• Congenital or acquired immunodeficiency diseases, including human immunodeficiency virus (HIV), or a history of organ transplantation or allogeneic stem cell transplantation;
• Patients with mental illnesses, substance abuse, or social issues that affect compliance will not be included in the group after being reviewed by a doctor
• Individuals who receive other long-term medication treatments and have been assessed by a doctor as potentially affecting disease progression.

Lab values

• Patients with baseline pathology of adenocarcinoma and inability to perform driver gene testing (including at least EGFR, ALK);

Other

• Baseline pathological examination reveals neuroendocrine components (including any percentage of small cell carcinoma, large cell carcinoma, differentiated neuroendocrine carcinoma, etc);
• Unable to perform RB1/TP53 testing ;
• Breastfeeding or pregnant women;

• Age ≥ 18 years old;
• ECOG function status score 0-2 points;
• Pathological diagnosis of stage III-IV non neuroendocrine non-small cell lung cancer;
• RB1/TP53 gene/protein testing (IHC, NGS, or other techniques are acceptable) has been completed and confirmed to be dual inactivation of RB1/TP53;
• For patients with baseline pathology of adenocarcinoma, complete driver gene testing (including at least EGFR and ALK);
• The patient undergoes at least one systemic treatment (chemotherapy, targeted drug therapy, immunotherapy, etc.) and receives regular follow-up;
• After discovering disease progression during the follow-up process, the patient will undergo further pathological biopsy of the progressing lesion after evaluation by the sub center PI;
• According to the researcher's assessment, the patient currently does not require palliative radiation therapy in any area;
• If the subject undergoes surgery, they must fully recover from the toxicity and complications of the surgical intervention before starting treatment;
• The subjects need to agree to provide corresponding peripheral blood and biopsy tissue samples before and during the follow-up treatment in accordance with the clinical trial protocol requirements;
• Men/women of childbearing age agree to use contraception during the trial period (surgical ligation or oral contraception/intrauterine device+condom contraception);
• Life expectancy ≥ 3 months;
• Patients must have the ability to understand and voluntarily sign informed consent forms.