Extensive-Stage Small Cell Lung Cancer
Conditions
Interventions
Experimental group:Etoposide soft capsules combined with immune checkpoint inhibitors
Sponsors
Army Medical Center of PLA
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Participants voluntarily join the study, provide signed informed consent, demonstrate good compliance, and cooperate with study visits; 2.Age >=18 years (calculated at the time of informed consent signing); 3.Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC); 4.ECOG performance status score of 0 or 1; 5.At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria; 6.No disease progression after 4 cycles of first-line induction therapy with immune checkpoint inhibitors plus chemotherapy (etoposide + cisplatin/carboplatin), as assessed by the investigator per RECIST v1.1 - achieving complete response (CR), partial response (PR), or stable disease (SD).
Exclusion criteria
Exclusion criteria: 1. Women who are pregnant or breastfeeding; 2. Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases; Note: Patients with treated CNS metastases who are asymptomatic at screening may be enrolled if they meet all of the following criteria:No evidence of progression between completion of CNS-directed local therapy and initiation of study treatment;Presence of measurable lesions outside the CNS; Only supratentorial metastases are allowed;No requirement for ongoing corticosteroid therapy for CNS disease; Stable doses of anticonvulsants are permitted;No history of intracranial hemorrhage or spinal cord hemorrhage;Patients meeting all other criteria, including those with a history of brain metastases, are eligible for study enrollment after treatment;Patients with asymptomatic CNS metastases assessed by the investigator as eligible may be enrolled; 3. Known hypersensitivity to etoposide soft capsules. 4. Active autoimmune disease or a history of autoimmune disease that may relapse; Note: Patients with the following conditions are not excluded and may undergo further screening:Well-controlled type 1 diabetes;Hypothyroidism (controlled with thyroid hormone replacement therapy only);Well-controlled celiac disease;Skin disorders not requiring systemic therapy (e.g., vitiligo, psoriasis, alopecia);Any other condition not expected to recur in the absence of external triggering factors; 5. Pericardial effusion of clinical significance; 6. Pleural effusion or ascites that is not clinically controlled or requires thoracentesis or paracentesis for drainage within 2 weeks prior to enrollment; 7. History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis; 8. Active tuberculosis; 9. Any concurrent illness that, in the investigator's judgment, seriously jeopardizes patient safety or compromises the patient's ability to complete the study; 10. Expected survival of less than 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progress free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of response;Overall survival;Safety ; | — |
Countries
China
Contacts
Public ContactMingxia Feng
Army Medical Center of PLA
Outcome results
None listed