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SCLC,Extensive StagePhase 2NCT07141264

Adebrelimab Combine With Etoposide Capsules in ES-SCLC Maintenance Therapy

A Phase 2 study testing Adebrelimab combined with Etoposide Capsules in people with SCLC,Extensive Stage, run by Tang-Du Hospital 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

This prospective clinical study aims to evaluate and observe the efficacy and safety of adebrelimab combined with etoposide capsules in maintenance therapy for extensive-stage small cell lung cancer using a single-arm trial design. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
SCLC,Extensive Stage
What is being tested?
Adebrelimab combined with Etoposide Capsules
Type of treatment
Pill or oral medicine
How many people
32 participants
Where
1 siteChina
Study dates
25 Aug 2025to 30 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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntary participation with signed informed consent and good compliance for follow-up.
  • Age between 18 and 75 years old.
  • Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC) according to the AJCC 8th edition or VALG phase II staging criteria.
  • ECOG performance status score: 0 to 2.
  • Absence of disease progression after receiving 4-6 cycles of platinum-based chemotherapy combined with Adebrelimab induction therapy.
  • Recovery of non-hematologic adverse reactions to grade 1 (except for alopecia, skin pigment changes, or as determined by the investigator) following induction therapy.
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  • Time from the end of induction treatment (last dose) to initiation of maintenance treatment ≤ 6 weeks.
  • At least one measurable lesion assessed by the investigator according to RECIST 1.1.
  • Normal function of major organs, meeting the following criteria:
  • (1)Bone marrow function: Absolute neutrophil count (ANC) ≥ 1.5×10^9/L (grade 1 according to CTCAE 5.0); platelets ≥ 100×10^9/L; hemoglobin > 80g/L.
  • (2)Renal function: Creatinine ≤ 1.5 times the upper limit of normal (ULN), grade 1 according to CTCAE. Note: If creatinine is greater than 1.5 times the ULN, creatinine clearance must be > 50ml/min.
  • (3)Liver function: Bilirubin ≤ 1.5 times ULN (grade 1 according to CTCAE), patients with Gilbert's syndrome bilirubin ≤ 3.0 times ULN; AST and ALT ≤ 3.0×ULN.
  • (4)Coagulation indicators: International normalized ratio (INR) ≤ 1.55 (if the patient is receiving a stable dose of therapeutic warfarin or low molecular weight heparin, INR is usually between 2 and 3), PTT < 1.2 times ULN.
  • 10.Women of childbearing potential must agree to use contraception during the study and for 6 months after the end of the study (such as an intrauterine device, contraceptive pills, or condoms); serum or urine pregnancy test must be negative within 1 week before enrollment, and must be non-lactating patients; men must agree to use contraception during the study and for 6 months after the end of the study.

Who cannot join

  • Limited-stage small cell lung cancer (SCLC);
  • Histologically or cytologically confirmed mixed histology SCLC;
  • Prior treatment with anti-angiogenic agents;
  • Conditions that may affect oral drug intake, such as inability to swallow, chronic diarrhea, or intestinal obstruction;
  • Major surgery, open biopsy, or significant traumatic injury within 4 weeks prior to enrollment;
  • Participation in another investigational drug clinical trial within 4 weeks prior to enrollment;
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  • Relevant medical history:
  • (1)Untreated or symptomatic brain metastases or spinal cord compression; (2)Concurrent active malignancy requiring treatment; (3)Active autoimmune disease or immunodeficiency, or a history of such conditions, including but not limited to autoimmune hepatitis, interstitial lung disease, uveitis, rheumatoid arthritis, inflammatory bowel disease, hypophysitis, vasculitis, or nephritis.Exceptions include: patients with stable disease not requiring systemic immunosuppressive therapy, such as type I diabetes mellitus, hypothyroidism controlled with hormone replacement therapy, or skin disorders not requiring systemic treatment (e.g., vitiligo, psoriasis, or alopecia), or those with no external triggering factors and a low risk of recurrence; (4)History of psychiatric or substance abuse disorders that would interfere with study compliance; 8.Presence of any severe and/or uncontrolled comorbid conditions, including but not limited to:
  • Uncontrolled hypertension (systolic BP ≥150 mmHg or diastolic BP ≥100 mmHg);
  • Myocardial ischemia or infarction of grade I or higher, arrhythmias (including QTc ≥450 ms in males, ≥470 ms in females), congestive heart failure of NYHA class ≥2, or left ventricular ejection fraction (LVEF) <50% on echocardiogram;
  • Decompensated diabetes mellitus or other contraindications requiring high-dose corticosteroids;
  • Exacerbation of chronic obstructive pulmonary disease (COPD) or other serious respiratory disorders requiring hospitalization;
  • Active or uncontrolled severe infection (≥CTCAE grade 2);
  • Uncontrolled pleural, pericardial, or peritoneal effusion requiring repeated drainage;
  • Liver cirrhosis, decompensated liver disease, active hepatitis, or chronic hepatitis requiring antiviral treatment;
  • Renal insufficiency: urine protein ≥++ on routine urinalysis and 24-hour urine protein >1.0 g confirmed; 9.Severe infection within 4 weeks before the first dose, including but not limited to infectious complications, bacteremia, severe pneumonia requiring hospitalization, or infections requiring intravenous antibiotics, antifungals, or antivirals; or unexplained fever >38.5°C during screening or prior to first dose; 10.Grade III-IV immune-related adverse events (irAEs) during the induction phase with PD-L1 inhibitors; 11.Active brain or leptomeningeal metastases at enrollment; Exception: patients who received prior treatment (e.g., radiotherapy) for brain or leptomeningeal metastases during or before induction and had stable disease on imaging for at least 4 weeks prior to enrollment, discontinued systemic steroid therapy (≤10 mg/day prednisone or equivalent) for more than 4 weeks, and are asymptomatic, may be eligible; 12.Patients deemed by the investigator to be unable or unlikely to comply with the study protocol, restrictions, or requirements.

Trial locations and contacts

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

Lei Pan, Dr contact

13991161903

panlei@fmmu.edu.cn

China1 site, 1 recruiting

  • Tangdu Hospital Affiliated to the Fourth Military Medical University

    Xi'an, Shannxi, 710000

    Lei Pan, Dr, 13991161903, panlei@fmmu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: A Single-Arm, Exploratory Study of Adebrelimab Combined With Etoposide Capsules as Maintenance Therapy in Extensive-Stage Small Cell Lung Cancer

This prospective clinical study aims to evaluate and observe the efficacy and safety of adebrelimab combined with etoposide capsules in maintenance therapy for extensive-stage small cell lung cancer using a single-arm trial design.

The study is planned to be conducted in Shaanxi Province, China, with an initial target enrollment of 32 patients. The study commenced in August 2025, and recruitment is expected to conclude around December 2026, with the trial anticipated to end by December 2027. Assuming no occurrences such as withdrawal of informed consent by subjects, intolerable adverse drug reactions, or investigator-assessed unsuitability for further participation, each participant's estimated duration of study treatment will continue until radiographically confirmed tumor progression.

Being tested
Adebrelimab combined with Etoposide Capsules
Keywords
SCLC, Adebrelimab, Etoposide Capsules, Maintenance Therapy

What participants receive

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

  • Adebrelimab combined with Etoposide CapsulesDrug

    Each treatment cycle spans 3 weeks. Sequential medication administration begins on the first day of each cycle: Adebrelimab is administered at a dosage of 1200mg on day 1, every 3 weeks, while Etoposide Capsules is given orally at a dosage of 50mg or 25mg daily, day 1 to 14 of a 21-day cycle. Administration timing allows for a window of ±5 days. Subjects are required to undergo comprehensive assessments, including vital signs monitoring, anthropometric measurements, physical examinations, laboratory analyses, and performance status evaluations, to assess treatment tolerability for continuation.

What is being measured

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

  1. Progression-free survival

    Progression free survival (PFS) refers to the time from recording the first chemotherapy treatment to the date of disease progression, as assessed by researchers.

    Measured: Progression-free survival (PFS) analysis based on investigator assessment per RECIST 1.1, and will be assessed up to 2 years

Secondary outcomes (3)

  1. Overall Survival

    Overall survival (OS) refers to the time that researchers evaluate from recording the first chemotherapy to death (of any cause).

    Measured: The maximum time from receiving treatment to dying for any reason is 4 years.

  2. Objective response rate

    Per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) using Investigator assessments, is defined as the number (%) of patients with response of Complete Response or Partial Response, will be assessed up to 1 years.

    Measured: Data obtained up until progression, or the last evaluable assessment in the absence of progression, will be assessed up to 1 years.

  3. Duration of Response

    Duration of Response（DoR）refers to the time from the first assessment as CR or PR to the first assessment as PD or (due to any reason) death.

    Measured: Duration of Response（DoR）analysis based on investigator assessment per RECIST 1.1, and will be assessed up to 1 years.

Timeline

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

  1. First posted26 Aug 2025
  2. Study start25 Aug 2025
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion30 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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07141264
Sponsor's protocol ID
IIT20250816
Status last verified
Dec 2025
First submitted
19 Aug 2025
Last updated
30 Dec 2025
Results posted
No
Data monitoring committee
No
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 Adebrelimab combined with Etoposide Capsules in people with SCLC,Extensive Stage, run by Tang-Du Hospital 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 14 inclusion and 16 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 30 Dec 2025. 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 Lei Pan, Dr (13991161903, panlei@fmmu.edu.cn), 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: Progression-free survival (PFS) analysis based on investigator assessment per RECIST 1.1, and will be assessed up to 2 years). 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 NCT07141264.

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 30 Dec 2025; AzTrials last refreshed its copy on 6 Nov 2026.

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