Adebrelimab Combined With Oral Etoposide for Elderly Patients and Patients With Poor Performance … (NCT07398560) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Adebrelimab Combined With Oral Etoposide for Elderly Patients and Patients With Poor Performance Status in Small Cell Lung Cancer: An Exploratory Clinical Study
China47 participantsStarted 2026-02-01
Plain-language 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.
Who can participate
Age range18 Years – 99 Years
SexALL
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Inclusion criteria
✓. 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.
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
Progression-Free-Survival
Timeframe: up to 24 months
Trial details
NCT IDNCT07398560
SponsorThe Third Affiliated Hospital of Harbin Medical University
✕. 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:
✕. 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).