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New lung cancer cocktail aims to outperform standard care

NCT ID NCT07583511

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares two drug combinations for people with extensive-stage small-cell lung cancer who haven't had prior treatment. One group gets teniposide, cisplatin, and serplulimab; the other gets the standard etoposide, cisplatin, and serplulimab. The goal is to see which combo works better at delaying cancer growth. About 90 participants will take part across multiple centers.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
teniposide, cisplatin, serplulimab
What this could lead to
If it works, this could offer a more effective first-line treatment option for extensive-stage small-cell lung cancer, potentially improving how long patients live without their cancer getting worse.
What could go wrong
This is an early phase 2 trial with only 90 people, so results are not definitive. The new combination may not be better than the standard, and could have unexpected side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 90 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2024

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • SUN-YAT-SEN University Cancer Center

    RECRUITING

    Guangzhou, Guangdong, China

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