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Small-cell Lung CancerPhase 2NCT07583511

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

A Phase 2 study testing Teniposide, Etoposide and serplulimab in people with Small-cell Lung Cancer, run by Sun Yat-sen University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Small-cell Lung Cancer
What is being tested?
Teniposide, Etoposide and serplulimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteChina
Study dates
1 Feb 2024to 1 Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Wenfeng Fang contact

15322302066

48287672@qq.com

China1 site, 1 recruiting

  • SUN-YAT-SEN University Cancer Center

    Guangzhou, Guangdong

    Wenfeng Fang

    Recruiting

Other trials in China

About this study

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

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

Read the detailed description

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

Being tested
Teniposide, Etoposide, serplulimab, cisplatin
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TeniposideDrug

    Also called T

    To evaluate the efficacy and safety of teniposide regimen

  • EtoposideDrug

    Also called E

    For comparison

  • serplulimabDrug

    Also called S

    Fixed regimen

  • cisplatinDrug

    Also called P

    Fixed regimen

Study groups in NCT07583511
Study groupRoleWhat they receive
teniposide, cisplatin and serplulimabExperimentalteniposide Injection, cisplatin for injection, serplulimab injection.
Receives: Drug: Teniposide; Drug: serplulimab; Drug: cisplatin
etoposide, cisplatin and serplulimabActive comparatoretoposide capsule, cisplatin for injection, serplulimab injection.
Receives: Drug: Etoposide; Drug: serplulimab; Drug: cisplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival

    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).

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2026
  2. Study start1 Feb 2024
  3. Primary completion1 May 2027 (estimated)
  4. Study completion1 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07583511
Sponsor's protocol ID
TNBG-IIT001
Status last verified
May 2026
First submitted
23 Jul 2024
Last updated
13 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Teniposide, Etoposide and serplulimab in people with Small-cell Lung Cancer, run by Sun Yat-sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Wenfeng Fang (15322302066, 48287672@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07583511.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.

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