Extensive-stage small cell lung cancer
Conditions
Interventions
Experimental group:Immune checkpoint inhibitors combined with TTF therapy
Control group:Immune checkpoint inhibitor monotherapy
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Histologically and/or cytologically confirmed extensive-stage small cell lung cancer (SCLC) (according to the Veterans Affairs Lung Cancer Group [VALG] disease staging system). Patients with prior limited-stage SCLC may have received curative-intent chemoradiotherapy, provided there is a treatment-free interval of at least 180 days from the last chemotherapy, radiotherapy, or chemoradiotherapy to the diagnosis of extensive-stage SCLC (ES-SCLC); 2. Age between 18 and 75 years inclusive, regardless of gender; 3. Willingness to adhere to the study treatment protocol and follow-up schedule, voluntary enrollment, and written informed consent; 4. No prior systemic therapy for extensive-stage small cell lung cancer (ES-SCLC) other than induction therapy, with completion of at least 4 cycles of induction therapy. Complete tumor assessment records during induction therapy must be available, and no tumor progression (as per RECIST 1.1 criteria) should be documented post-induction therapy; 5. Estimated survival >= 3 months; 6. No prior thoracic radiotherapy for extensive-stage small cell lung cancer; 7. ECOG performance status 0-1; 8. Adverse events (AEs) from prior treatment must have resolved to baseline or CTCAE grade 1-2 (excluding alopecia and laboratory abnormalities deemed clinically insignificant by the investigator), and the investigator must assess that the AE does not preclude the subject from receiving study treatment or participating in study assessments; 9. Serum pregnancy test negative for female subjects of childbearing potential. Female subjects of childbearing potential must use effective contraception (e.g., hormonal, barrier methods, or abstinence) during the study and for 1 month after treatment completion; 10. Male subjects agree to use effective contraception (e.g., barrier methods or abstinence) during the study period and for 1 month after treatment completion, and will not donate sperm; 11. Able to operate the tumor electric field therapy device independently or with caregiver assistance.
Exclusion criteria
Exclusion criteria: 1. Mixed-type small cell lung cancer or other histological subtypes of lung cancer; 2. Presence of symptomatic brain metastases, or metastases involving the meninges or brainstem, or spinal cord compression; symptomatic brain metastases may be included if stable and asymptomatic for at least 4 weeks following treatment; 3. Major organ surgery within 4 weeks prior to first study treatment (excluding needle biopsy or significant trauma), or requiring elective surgery during the study period; 4. History of another malignancy within 2 years prior to first study treatment; except for locally curable cancers treated with curative intent, such as basal or squamous cell skin carcinoma, superficial bladder carcinoma, or carcinoma in situ of the prostate, cervix, or breast; 5. Abnormal bone marrow, cardiac, hepatic, or renal function: a. Neutrophil count 1.5 × upper limit of normal (ULN); c. Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 2.5 × ULN; in patients with liver metastases, ALT and AST > 5 × ULN; d. Serum creatinine > 3 × ULN; e. Coagulation function: International Normalized Ratio (INR) >1.5 times ULN, Activated Partial Thromboplastin Time (APTT) >1.5 times ULN (excluding patients receiving anticoagulant therapy); 6. Presence of uncontrolled interstitial lung disease, including but not limited to interstitial pneumonia, pulmonary fibrosis (excluding radiation-induced pulmonary fibrosis not requiring corticosteroid therapy); 7. History of severe cardiovascular or cerebrovascular disease or deep vein thrombosis, including but not limited to: • Severe cardiac rhythm or conduction abnormalities, such as clinically significant ventricular arrhythmias or second- or third-degree atrioventricular block; • At rest, Fridericia-corrected QT interval (QTcF): Male > 450 ms for males, >470 ms for females; • Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other Grade 3 or higher (CTCAE 6.0) cardiovascular/cerebrovascular events within 6 months prior to the first study treatment; • Heart failure with New York Heart Association (NYHA) functional class >= II (see Appendix X) or left ventricular ejection fraction (LVEF) =160 mmHg and/or diastolic blood pressure >=100 mmHg); • New-onset pulmonary embolism within 6 months prior to first study treatment, or new-onset lower extremity deep vein thrombosis within 30 days; 8. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 9. Active infection within 3 days prior to first study treatment requiring current intravenous antimicrobial therapy; 10. History of human immunodeficiency virus (HIV) infection (known HIV-1/2 antibody positive) or known active syphilis infection; 11. Patients with active hepatitis B (defined as positive hepatitis B surface antigen or core antibody test results during screening, accompanied by HBV-DNA levels exceeding 500 copies/ml) or hepatitis C (defined as positive hepatitis C virus antibody [HCV-Ab] test results during screening, with concurrent HCV-RNA positivity); 12. Individuals scheduled to receive live vaccines within 4 weeks prior to the first study treatment, during the study treatment period, or within 4 weeks after the last study treatm
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS) (BIRC assessment, based on RECIST 1.1); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival time (OS);Progression-free survival (PFS) (INV assessment);Incidence and severity of adverse events;Time to disease progression (TTP) (BIRC and INV assessment);Objective response rate (ORR) (BIRC and INV assessment);Disease Control Rate (DCR) (BIRC and INV assessment);Correlation between the average daily treatment duration and efficacy of TTF;Time to disease progression following TTF treatment;Evaluation of Equipment Performance; | — |
Countries
China
Contacts
Public ContactZhang Li
Sun Yat-sen University Cancer Center
Outcome results
None listed