Teniposide, Cisplatin and Serplulimab for Treatment of ES-SCLC, a Randomized Controlled Study

May 7, 2026 updated by: Li Zhang, MD, Sun Yat-sen University

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

To compare the efficacy and safety between teniposide, cisplatin and serplulimab regimen and etoposide, cisplatin and serplulimab regimen in the treatment of extensive stage small lung cancer

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Two arms trial, PFS for outcome, for patients in extensive stage of SCLC

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China
        • Recruiting
        • SUN-YAT-SEN University Cancer Center
        • Contact:
          • Wenfeng Fang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: teniposide, cisplatin and serplulimab
teniposide Injection, cisplatin for injection, serplulimab injection.
Drug: Teniposide
To evaluate the efficacy and safety of teniposide regimen
Other Names:
  • T
Drug: serplulimab
Fixed regimen
Other Names:
  • S
Drug: cisplatin
Fixed regimen
Other Names:
  • P
Active Comparator: etoposide, cisplatin and serplulimab
etoposide capsule, cisplatin for injection, serplulimab injection.
Drug: serplulimab
Fixed regimen
Other Names:
  • S
Drug: cisplatin
Fixed regimen
Other Names:
  • P
Drug: Etoposide
For comparison
Other Names:
  • E

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival
Time Frame: 1 year
Baseline tumor evaluation is conducted according to the RECIST 1.1 standard. Completed within 4 weeks before administration. Imaging (CT or MRI) examinations of the chest, abdomen, and head are performed. If necessary, appropriate methods (CT scan or MRI) can be used to examine any other known or suspected disease site (such as the pelvic cavity).
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Principal Investigator: Wenfeng Fang, Sun Yat-sen University Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2024

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

July 23, 2024

First Submitted That Met QC Criteria

May 7, 2026

First Posted (Actual)

May 13, 2026

Study Record Updates

Last Update Posted (Actual)

May 13, 2026

Last Update Submitted That Met QC Criteria

May 7, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TNBG-IIT001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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