Status:
RECRUITING
Adebrelimab Combine With Etoposide Capsules in ES-SCLC Maintenance Therapy
Lead Sponsor:
Tang-Du Hospital
Conditions:
SCLC,Extensive Stage
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 u...
Eligibility Criteria
Inclusion
- 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.
- 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.
- 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
- 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;
- 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.
Key Trial Info
Start Date :
August 25 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2027
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT07141264
Start Date
August 25 2025
End Date
December 30 2027
Last Update
December 30 2025
Active Locations (1)
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1
Tangdu Hospital Affiliated to the Fourth Military Medical University
Xi'an, Shannxi, China, 710000