This study is a prospective, single arm, phase II clinical trial. We plan to include 36 newly diagnosed ES-SCLC patients who meet the inclusion criteria and receive induction therapy (tislelizumab+EP regimen, 4-6 cycles). After completing the induction therapy, efficacy evaluation will be conducted. Patients with remission will receive tislelizumab combined with consolidation chest radiotherapy (TRT) sequentially. After the consolidation therapy is completed, they will receive tislelizumab maintenance therapy until disease progression, intolerable toxicity, or withdrawal of informed consent occurs, whichever occurs first. The treatment duration will not exceed 2 years.
Signed informed consent;
Age 18-75 years;
According to the judgment of the investigator, the patient was able to comply with the study protocol;
Histologically or cytologically confirmed extensive stage small cell lung cancer (es-sclc) (according to the Veterans Administration lung cancer association [valg] staging system);
Symptomatic, untreated, or actively progressive central nervous system (CNS) metastases; ·Patients with CNS lesions who were treated and asymptomatic were eligible for this study if they met all of the following criteria: measurable lesions that met the recistv1.1 definition were outside the CNS; The patient had no history of intracranial hemorrhage or spinal cord hemorrhage; Patients did not receive stereotactic radiotherapy within 7 days before the start of study treatment, whole brain radiotherapy within 14 days before the start of study treatment, or neurosurgical resection within 28 days before the start of study treatment; Patients do not need to continue to receive corticosteroids for CNS disease. Treatment with stable doses of anticonvulsants was allowed. Metastasis was limited to the cerebellum or supratentorial region (i.e., not to the midbrain, pons, medulla oblongata, or spinal cord); There was no evidence of progression between the completion of CNS local therapy and the initiation of study therapy asymptomatic patients with CNS metastases who could be enrolled according to the assessment of other investigators could be enrolled;
History of leptomeningeal disease;
Poorly controlled pleural effusion, pericardial effusion or ascites requiring repeated drainage (once a month or more frequently);
Poorly controlled or symptomatic hypercalcemia (ionized calcium >1.5mmol/l, calcium >12mg/dl or corrected calcium >uln);
Single group
Tislelizumab Combined With Chemotherapy
DrugPatients with newly diagnosed ES-SCLC receive induction therapy (tislelizumab+EP regimen, 4-6 cycles). After completing the induction therapy, efficacy evaluation is conducted. Those who experience remission are sequentially treated with tislelizumab combined with consolidation chest radiotherapy (TRT). After the consolidation therapy is completed, tislelizumab maintenance therapy is received until disease progression, intolerable toxicity, or withdrawal of informed consent occurs, whichever occurs first. The maximum duration of treatment is 2 years.
progression-free survival
Progression free survival (PFS): defined as the period from enrollment to the date of the first recorded tumor progression (assessed according to RECIST v1.1 criteria, regardless of whether treatment is continued or not) or the date of death from any cause, whichever occurs first, assessed up to 24 months.
Objective response rate
Defined as the proportion of patients with BOR rated as CR or PR according to RECIST v1.1 criteria from the start of enrollment. If the therapeutic effect reaches CR or PR, the patient must confirm it no less than 4 weeks (28 days) after the initial evaluation, assessed up to 6 weeks (42 days) . The best overall efficacy refers to the best efficacy evaluated by the researcher, which is the best efficacy recorded during the period from the patient's enrollment to the date of objective recording of disease progression according to RECIST v1.1 standards or the date of starting subsequent anti-tumor treatment (whichever occurs first). For patients who have not recorded disease progression or started subsequent anti-tumor treatment, the optimal overall efficacy will be determined based on all efficacy evaluation results.
Disease control rate
Defined as the proportion of patients who, from enrollment, have the best overall response (BOR) evaluated according to RECIST v1.1 criteria as complete response (CR), partial response (PR), and disease stability (SD).
Duration of remission
Defined as the time from the first recorded objective remission to recurrence or death for any reason, as determined by the researcher based on RECIST v1.1, whichever occurs first.
Overall survival
Defined as the time between enrollment and death from any cause.
the incidence of treatment-emergent adverse events
Defined as the incidence of treatment-emergent adverse events \[safety and tolerability\].
Click on the lead sponsor to view all of their trials.
