Small Cell Lung Cancer (SCLC)
Conditions
Interventions
Observation group:NA
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Voluntarily sign the Informed Consent Form (ICF) after fully understanding this study; 2. Age >18 years, no gender restriction; 3. Histologically or cytologically confirmed extensive-stage small cell lung cancer; 4. At least one measurable lesion per RECIST version 1.1; 5. Receiving immunotherapy combined with chemotherapy; prophylactic use of pegylated recombinant human granulocyte colony-stimulating factor after chemotherapy; 6. ECOG performance status 0–2; estimated survival >=3 months; 7. Laboratory tests before the first dose confirm that the patient's bone marrow function, hepatic function, and renal function meet the following requirements: (1) Absolute neutrophil count (ANC) >= 2,000/mm^3 (2.0×10^9/L); (2) Platelet count (PLT) >= 100,000/mm^3 (100×10^9/L); (3) Hemoglobin (Hb) >=8 g/dL (80 g/L); (4) Serum creatinine (SCr) = 60 mL/min; (5) Total bilirubin (TBIL) <= 1.5 × ULN; (6) Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) <= 2.5 × ULN; for patients with liver metastases, <= 5 × ULN; (7) International normalized ratio (INR) <= 1.5, prothrombin time (PT) and activated partial thromboplastin time (APTT) <= 1.5 × ULN; 8. Willing and able to comply with scheduled visits, laboratory tests, and other study procedures.
Exclusion criteria
Exclusion criteria: 1. Uncontrolled infection 2. Myelodysplasia or other hematopoietic abnormalities 3. Pregnancy or lactation 4. History of other malignancies 5. Unable to provide written informed consent 6. Currently participating in another interventional clinical study 7. Inability to comply with the scheduled follow-up visits or unavailability of prior safety data as deemed by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Grade 3-4 Neutropenia.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of Febrile Neutropenia (FN).;Chemotherapy Completion Rate for Cycles 2-4;Safety;Objective Response Rate (ORR);Disease Control Rate (DCR);Progression-Free Survival (PFS);Overall Survival (OS); | — |
Countries
China
Contacts
Public ContactSi Xiaoyan
Peking Union Medical College Hospital
Outcome results
None listed