Teniposide + cisplatin + serplulimab versus etoposide + cisplatin + serplulimab for extensive-stage small-cell lung cancer
Official title: Comparison of Teniposide, Cisplatin and Serplulimab Regimen With Etoposide, Cisplatin and Serplulimab Regimen for Treatment of Extensive Stage Small Lung Cancer, a Random, Open Label, Positive Control, Multicenter Study
Run by Sun Yat-sen University · NCT07583511 · Data updated 2026-11-12
This study tests whether replacing etoposide with teniposide, while keeping cisplatin and serplulimab, works better for adults with extensive-stage small-cell lung cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 90 (estimated) |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | chemotherapy, radiation, prednisone, serplulimab |
| Locations | 1 site (Guangzhou, Guangdong) |
| Status | Recruiting |
| Started | February 1, 2024 |
| Main results expected | May 1, 2027 |
| Study ends | December 1, 2027 |
| Registry record updated | May 13, 2026 |
| Trial ID | NCT07583511 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with pathologically confirmed extensive-stage SCLC, ECOG 0–1, adequate organ function, and either no prior systemic therapy for extensive-stage disease or prior limited-stage therapy with at least a 6-month interval are the intended participants.
✕Probably not a fit
Patients who have already received systemic therapy for extensive-stage SCLC, have poor performance status, significant organ dysfunction, or contraindications to platinum chemotherapy or PD‑1 therapy are unlikely to benefit from enrollment.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized, phase 2 trial comparing two chemotherapy backbones given with the anti–PD‑1 antibody serplulimab in patients with extensive-stage small-cell lung cancer. Participants are randomly assigned to receive either teniposide plus cisplatin and serplulimab or etoposide plus cisplatin and serplulimab, with progression-free survival as the primary endpoint. Eligible adults have ECOG 0–1, adequate organ function, and either no prior systemic treatment for extensive-stage disease or prior limited-stage therapy with at least a six-month treatment-free interval. The study is conducted at Sun Yat-sen University Cancer Center and requires in-person treatment and monitoring.
Why it matters
Potential benefit: If successful, this regimen could extend the time patients live without disease progression or offer a better-tolerated chemotherapy option when combined with serplulimab.
How similar studies have gone: Large trials have shown that adding PD‑1/PD‑L1 antibodies to platinum–etoposide improves outcomes in extensive-stage SCLC, but substituting etoposide with teniposide is a newer approach with limited prior data.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Has not received systematic treatment for extensive stage small cell lung cancer in the past * Extensive stage small cell lung cancer patients who have been pathologically proven to be intolerant to synchronous radiotherapy and chemotherapy * Patients who have previously received radiotherapy and chemotherapy for limited stage SCLC and have had an untreatable interval of at least 6 months from the end of systemic treatment to SCLC recurrence * Lesions can only be considered measurable if there is clear progression of a previously irradiated lesion after radiotherapy, and the previously irradiated lesion is not the only one * Age≥18 years * ECOG: 0-1 * Expected survival time exceeds 3 months * Hb≥100g/L; ANC≥1.5×109/L; PLT≥100×109/L; WBC≥3.0×109/L; ALT and AST≤2.5×ULN(with tumor liver metastases, ≤5×ULN); TBIL≤1.5×ULN(with tumor liver metastases,≤3×ULN); Cr≤1.5×ULN or EGFR≥50ml/min; APTT, INR, PT≤1.5×ULN; LVEF≥50% * Women of childbearing age should agree to use contraceptive measures during the study period and within 6 months after the end of the study. Serum pregnancy test negative within 28 days prior to enrollment in the study, and must be a non lactating subject. Men should be subjects who agree to use contraception during the study period and within 6 months after the end of the study period * The subjects should sign an informed consent form and had good compliance Exclusion Criteria: * Patients with unstable or clinically symptomatic brain metastases, including those with central symptoms, brain edema, and those requiring radiation therapy * Active autoimmune diseases that require systemic treatment (such as the use of disease relieving drugs, corticosteroids, or immunosuppressants) within the two years prior to enrollment * Diagnosed with immunodeficiency or receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy (dose\>10mg/day prednisone or other effective hormones), and continuing to use within 2 weeks prior to enrollment * Within 5 years, the subject has previously or simultaneously suffered from other malignant tumors that have not been cured * With multiple factors that affect oral medication, such as inability to swallow, postoperative gastrointestinal resection, chronic diarrhea, and intestinal obstruction * Uncontrollable pleural effusion, pericardial effusion, or ascites that require repeated drainage * Spinal cord compression that cannot be cured or relieved by surgery and/or radiotherapy, or previously diagnosed spinal cord compression with no clinical evidence of disease stabilization for ≥ 1 week before enrollment after treatment * Within 2 weeks prior to enrollment, there was significant hemoptysis * Subjects who did not recover to ≤ CTCAE v5.0 level 1 due to adverse events caused by previous treatment (excluding hair loss) * Received significant surgical treatment or significant traumatic injury within 28 days prior to enrollment * Serious arterial/venous thrombotic events, such as cerebrovascular accidents, deep vein thrombosis, and pulmonary embolism, occurred within the 6 months prior to enrollment * Individuals with a history of psychiatric drug abuse who are unable to quit or have mental disorders * Subjects with poor blood pressure control (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg) (excluding patients who were able to control blood pressure with dual drugs before enrollment); 2) Suffering from grade I or above myocardial ischemia or infarction, arrhythmia (including male QTc ≥ 450ms (male), QTc ≥ 470ms (female)), and ≥ grade 2 congestive heart failure (New York Heart Association (NYHA) classification); 3) Active or uncontrolled severe infection (≥ CTCAE v5.0 level 2 infection); 4) Cirrhosis, active hepatitis \[known carriers of hepatitis B virus (HBV) must exclude active HBV infection, i.e. HBV DNA positive (\>1 × 104 copies/mL or\>2000 IU/ml); Known hepatitis C virus infection (HCV) and HCV RNA positivity (\>1 × 103 copies/mL, or other types of hepatitis or cirrhosis; 5) HIV test positive; 6) Urine routine indicates that urine protein is ≥ 3+, and it is confirmed that 24-hour urine protein quantification is greater than 3.0g; * No blood transfusion, albumin therapy, recombinant human thrombopoietin or colony stimulating factor (CSF) treatment was performed within 14 days prior to the first dose in this study * According to the researcher's judgment, there are accompanying diseases that seriously endanger the safety of the subjects or affect the completion of the study by the patients
Where it's running
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SUN-YAT-SEN University Cancer Center
Guangzhou, Guangdong, China Recruiting
Study contacts
- Principal investigator: Wenfeng Fang — Sun Yat-Sen University Cancer Center
- Study coordinator: Wenfeng Fang
- Email: 48287672@qq.com
- Phone: 15322302066
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.