New combo aims to keep advanced lung cancer in check
NCT ID NCT07141264
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether combining the immunotherapy drug adebrelimab with the chemotherapy drug etoposide (as capsules) can help control extensive-stage small cell lung cancer after initial treatment. About 32 adults in China will receive the combination every three weeks until their cancer worsens. The goal is to see if this maintenance therapy extends the time before the disease progresses.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Adebrelimab (an immunotherapy drug) combined with etoposide capsules (a chemotherapy drug)
- What this could lead to
- If successful, this could offer a new maintenance therapy option to help control extensive-stage small cell lung cancer and delay its progression.
- What could go wrong
- This is a small, early-phase (Phase 2) exploratory study with only 32 participants, so results may not apply broadly. The combination may cause side effects or fail to improve outcomes.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 32 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: 1. Voluntary participation with signed informed consent and good compliance for follow-up. 2. Age between 18 and 75 years old. 3. Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC) according to the AJCC 8th edition or VALG phase II staging criteria. 4. ECOG performance status score: 0 to 2. 5. Absence of disease progression after receiving 4-6 cycles of platinum-based chemotherapy combined with Adebrelimab induction therapy. 6. Recovery of non-hematologic adverse reactions to grade 1 (except for alopecia, skin pigment changes, or as determined by the investigator) following induction therapy. 7. Time from the end of induction treatment (last dose) to initiation of maintenance treatment ≤ 6 weeks. 8. At least one measurable lesion assessed by the investigator according to RECIST 1.1. 9. 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. Exclusion Criteria: 1. Limited-stage small cell lung cancer (SCLC); 2. Histologically or cytologically confirmed mixed histology SCLC; 3. Prior treatment with anti-angiogenic agents; 4. Conditions that may affect oral drug intake, such as inability to swallow, chronic diarrhea, or intestinal obstruction; 5. Major surgery, open biopsy, or significant traumatic injury within 4 weeks prior to enrollment; 6. Participation in another investigational drug clinical trial within 4 weeks prior to enrollment; 7. 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: 1. Uncontrolled hypertension (systolic BP ≥150 mmHg or diastolic BP ≥100 mmHg); 2. 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; 3. Decompensated diabetes mellitus or other contraindications requiring high-dose corticosteroids; 4. Exacerbation of chronic obstructive pulmonary disease (COPD) or other serious respiratory disorders requiring hospitalization; 5. Active or uncontrolled severe infection (≥CTCAE grade 2); 6. Uncontrolled pleural, pericardial, or peritoneal effusion requiring repeated drainage; 7. Liver cirrhosis, decompensated liver disease, active hepatitis, or chronic hepatitis requiring antiviral treatment; 8. 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.
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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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Tangdu Hospital Affiliated to the Fourth Military Medical University
RECRUITINGXi'an, Shannxi, 710000, China
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