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Small Cell Lung CancerPhase 2NCT07398560

Adebrelimab Combined With Oral Etoposide for Elderly Patients and Patients With Poor Performance Status in Small Cell Lung Cancer: An Exploratory Clinical Study

A Phase 2 study testing Adebrelimab and Oral etoposide soft capsules in people with Small Cell Lung Cancer, run by The Third Affiliated Hospital of Harbin Medical University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This is a multicenter, single-arm, exploratory clinical study designed to observe and evaluate the efficacy and safety of adebrelimab combined with oral etoposide for elderly patients and patients with poor performance status in small cell lung cancer. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Small Cell Lung Cancer
What is being tested?
Adebrelimab and Oral etoposide soft capsules
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
1 siteChina
Study dates
1 Feb 2026to 1 Feb 2029
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 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Extensive-stage or locally advanced small cell lung cancer at initial diagnosis.
  • Confirmed by pathological histology/cytology combined with imaging.
  • ECOG PS 2-3 or age ≥65 years.
  • If a large number of comorbidities exist: ① mild failure or cachexia; ② mild bone marrow reserve dysfunction; ③ mild cardiovascular, liver, or kidney dysfunction, or dysfunction of other important organs; ④ mild infection, provided anti-infection treatment is administered; ⑤ mild water-electrolyte or acid-base imbalance, provided symptomatic treatment is given; ⑥ incomplete gastrointestinal obstruction caused by tumors; ⑦ other mild contraindications to anti-tumor therapy, if the investigator determines that the patient can be enrolled (reference: Modern Oncology, 3rd Edition, Tang Zhaoyou, Antitumor Drug Therapy, Contraindications), then patients with ECOG PS 0-1 and age <65 are allowed.
  • Has measurable tumor target lesions (meeting RECIST 1.1 criteria).
  • Expected survival > 3 months.
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  • The functions of major organs meet the following requirements (excluding the use of any blood components and cell growth factors during the screening period):
  • Complete blood count (without blood transfusion or use of hematopoietic growth factors to correct the condition within 14 days): Hemoglobin (Hb) ≥90 g/L; Absolute neutrophil count (ANC) ≥1.5×10^9 /L; Platelets (PLT) ≥100×10^9 /L; White blood cell count (WBC) ≥3.0×10^9 /L.
  • Biochemical tests: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN (for patients with liver metastases, ≤ 5×ULN); serum total bilirubin (TBIL) ≤ 1.5×ULN (for subjects with Gilbert's syndrome, ≤ 3×ULN); serum creatinine (Cr) ≤ 1.5×ULN or creatinine clearance ≥ 50 ml/min.
  • Coagulation function: Activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) ≤1.5×ULN.
  • Doppler ultrasound assessment: Left ventricular ejection fraction (LVEF) ≥50%.
  • Women of childbearing age must have a negative pregnancy test (βHCG) before starting treatment. Women of childbearing age and men (who have sexual relations with women of childbearing age) must agree to use effective contraception continuously during the treatment and for 6 months after the last dose.
  • The patient voluntarily joined this study and signed the informed consent form.

Who cannot join

  • Within the past 2 years, having had or currently having other malignant tumors, except for cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, superficial or non-invasive bladder cancer, etc.
  • Active tuberculosis infection.
  • Individuals with uncontrolled or symptomatic brain metastases, a history of poorly controlled psychiatric disorders, or severe intellectual or cognitive impairments.
  • Participants with active, known, or suspected autoimmune diseases, those with hypothyroidism requiring only hormonal replacement therapy, or those with skin conditions not requiring systemic treatment (such as vitiligo, psoriasis, or hair loss) can be included.
  • Pleural effusion, pericardial effusion, or ascites that cannot be controlled and require repeated drainage (patients whose effusion has been stable for 2 weeks or more after treatment can be enrolled).
  • Subjects with any of the following severe and/or uncontrolled diseases, including:
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  • Subjects with poorly controlled blood pressure (systolic >160 mmHg or diastolic >100 mmHg).
  • Patients with ≥Grade 2 myocardial ischemia or myocardial infarction, severe arrhythmias (including QTc ≥450 ms in men, QTc ≥470 ms in women), and ≥Grade 2 congestive heart failure (New York Heart Association [NYHA] classification).
  • History of psychiatric medication abuse, alcoholism, or drug use.
  • Active hepatitis (for hepatitis B reference: HBsAg positive and HBV DNA test value greater than 500 IU/ml; for hepatitis C reference: HCV antibody positive and HCV viral load test value exceeding the upper limit of normal) human immunodeficiency virus (HIV, HIV 1/2 antibody) positive.
  • Severe bone marrow suppression is present.
  • Pregnant women or women who may be pregnant.
  • Patients who cannot comply with the trial protocol or cannot cooperate with follow-up.
  • Unable to swallow pills, malabsorption syndrome, or any condition that affects gastrointestinal absorption.
  • Researchers believe those who should not participate in this trial.

Trial locations and contacts

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

Fang Liu, MD contact

86+18045041129

liufangxuyu@163.com

China1 site

  • The Third Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150000

    Fang Liu, MD, 86+18045041129, liufangxuyu@163.com

    Fang Liu, MD

Other trials in China

About this study

This is a multicenter, single-arm, exploratory clinical study designed to observe and evaluate the efficacy and safety of adebrelimab combined with oral etoposide for elderly patients and patients with poor performance status in small cell lung cancer.

Read the detailed description

This is a multicenter, single-arm, exploratory clinical study planned to enroll 47 patients, aiming to evaluate the efficacy and safety of adebrelimab combined with oral etoposide for elderly patients and patients with poor performance status in small cell lung cancer.

Being tested
Adebrelimab, Oral etoposide soft capsules
Keywords
Small cell lung cancer, Oral etoposide, Elderly patients
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.

  • AdebrelimabDrug

    Adebrelimab: 1200 mg, administered by intravenous infusion, once every 3 weeks, repeated until disease progression, unacceptable toxicity, or the patient has received a cumulative total of 2 years of adebrelimab treatment.

  • Oral etoposide soft capsulesDrug

    Oral etoposide soft capsules: 75 mg, days 1-14, orally once daily, administered for 2 weeks followed by 1 week off.

Study groups in NCT07398560
Study groupRoleWhat they receive
Adebrelimab Combined with Oral EtoposideExperimentalAdebrelimab: 1200 mg, administered by intravenous infusion, once every 3 weeks, repeated until disease progression, unacceptable toxicity, or the patient has received a cumulative total of 2 years of adebrelimab treatment. Oral etoposide soft capsules: 75 mg, days 1-14, orally once daily, administered for 2 weeks followed by 1 week off. Investigators may administer prophylactic cranial irradiation at their discretion.
Receives: Drug: Adebrelimab; Drug: Oral etoposide soft capsules

What is being measured

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

  1. Progression-Free-Survival

    Defined as the time from randomization to the first occurrence of disease progression with use of RECIST v1.1 or death from any cause, whichever occurs first.

    Measured: up to 24 months

Secondary outcomes (5)

  1. Objective Response Rate

    Determined using RECIST v1.1 criteria, defined as best overall response (CR or PR) across all assessment time points during the period from enrolment to termination of trial treatment.

    Measured: up to 24 months

  2. Disease control rate

    Disease Control Rate (DCR) is defined as the proportion of evaluable patients who achieve either an objective response (Complete or Partial Response) or maintain Stable Disease following a therapeutic intervention.

    Measured: up to 24 months

  3. Overall Survival

    Defined as the time from randomization to death from any cause.

    Measured: up to 24 months

  4. Safety: Incidence of adverse events

    Incidence of adverse events

    Measured: up to 24 months

  5. Patient-Reported Outcomes (PROs)

    European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (Version 3.0)

    Measured: Up to 24 months

Timeline

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

  1. First posted10 Feb 2026
  2. Study start1 Feb 2026 (estimated)
  3. Primary completion1 Feb 2028 (estimated)
  4. Study completion1 Feb 2029 (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
47 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07398560
Sponsor's protocol ID
SHR-1316-HLJ-015
Status last verified
Feb 2026
First submitted
25 Jan 2026
Last updated
10 Feb 2026
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 and Oral etoposide soft capsules in people with Small Cell Lung Cancer, run by The Third Affiliated Hospital of Harbin Medical 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 13 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: opening soon, as of the sponsor's last update on 10 Feb 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 Fang Liu, MD (86+18045041129, liufangxuyu@163.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: up to 24 months). 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 NCT07398560.

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 10 Feb 2026.

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