DRUG
Immuno-chemotherapy
Immuno-chemotherapy regimen included etoposide, cisplatin, iparomlimab and tuvonralimab, and thymosin alpha 1.
Status
Not yet recruiting
Phase
Phase 2
Enrollment
56
Locations
1
Results
Not posted
Publications
6
Study summary
This study will enroll patients with limited-stage small cell lung cancer (SCLC). Patients will receive chemotherapy (etoposide and platinum-based drugs) combined with dual immune checkpoint blockade (PD-1/CTLA-4) and thymosin alpha 1, with a total cycles of 4. Thoracic radiotherapy was performed no later than the three cycle of chemotherapy. Prophylactic cranial irradiation was recommended for patients who received complete response or partial response after chemoradiotherapy. Finally consolidation therapy with dual immune checkpoint blockade (PD-1/CTLA-4) and thymosin alpha 1 was conducted for one year. The study aims to evaluate the efficacy and safety of this treatment regimen.
Interventions
DRUG
Immuno-chemotherapy regimen included etoposide, cisplatin, iparomlimab and tuvonralimab, and thymosin alpha 1.
RADIATION
Definitive dose of thoracic radiotherapy was delivered no later than the three cycle of immuno-chemotherapy. Prophylactic cranial irradiation (PCI) was delivered with a total dose of 25Gy in 10 fractions. PCI was recommended for patients who achieved complete response or partial response after thoracic chemoradiotherapy.
DRUG
Consolidation therapy regimen included iparomlimab and tuvonralimab, and thymosin alpha 1, with a duration of one year.
Timeline
First posted
Aug 5, 2025
Study start
Oct 1, 2025
Primary completion
Sep 30, 2029
Study completion
Sep 30, 2029
Results posted
Not reported
Registry updated
Aug 5, 2025
Outcomes
Progression-free survival
Time frame · 2-year
PFS measures the time from the start date of treatment to disease progression, death from any cause or last follow up if alive.
Overall survival
Time frame · 2-year
OS measures the time from the start date of treatment to death from any cause or last follow up if alive.
Treatment-related toxicity
Time frame · through study completion, an average of 18 months
Treatment-related toxicities were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) 5.0 toxicity
Eligibility
Inclusion Criteria: * Males or females aged 18 to 75 years or older; * Patients must have histologically or cytologically confirmed small cell lung cancer (SCLC); * Stage II-III according to AJCC 8th staging system; * No prior chemotherapy, radiotherapy, surgery, targeted therapy, or immunotherapy; * Expected survival ≥ 12 weeks; * WHO Performance Status (PS) score of 0 or 1; * Female subjects must not be breastfeeding; * Women of childbearing potential (WOCBP) must agree to use contraception during the study treatment and for 5 months after the last dose of study drug (i.e., 30 days \[one ovulation cycle\] plus approximately five half-lives of the study drug); * Adequate organ and bone marrow function as defined by the following criteria: * Forced Expiratory Volume in 1 second (FEV1) ≥ 800 mL; * Absolute neutrophil count ≥ 1.5 × 10⁹/L; * Platelets ≥ 100 × 10⁹/L; * Hemoglobin ≥ 9.0 g/dL; * Creatinine clearance ≥ 50 mL/min as calculated by the Cockcroft-Gault formula (Cockcroft and Gault, 1976); * Serum bilirubin ≤ 1.5 × upper limit of normal (ULN); * AST and ALT ≤ 2.5 × ULN. Exclusion Criteria: * Concurrent enrolment in another clinical study, unless it is an observational(non-interventional) clinical study; * Mixed small cell and non-small cell lung cancer histology; * Prior use of anti-PD-1, anti-PD-L1, or anti-CTLA4 antibodies; * Recent major surgery within 4 weeks prior to entry into the study (excluding the placement of vascular access; * Active or prior documented autoimmune disease within the past 2 years; * Active or prior documented inflammatory bowel disease (eg. Crohn's disease, ulcerative colitis); * History of primary immunodeficiency; * History of organ transplant that requires therapeutic immunosuppression; * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active bleeding diatheses including any patient known to have hepatitis B, hepatitis C or human immunodeficiency virus (HIV), or psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the patient to give written informed consent; * Known history of tuberculosis; * History of another primary malignancy within 5 years prior to starting treatment, except for adequately treated basal or squamous cell carcinoma of the skin or cancer of the cervix in situ and the disease under study; * Female patients who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control.
Study locations
China. Showing up to 24 locations stored in the fast local snapshot.
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Publications
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