A Single-arm, Multicenter, Prospective Phase II Clinical Study of Apatinib in Combination With Adebrelimab and EC Regimen in the First-line Treatment of Extensive Small Cell Lung Cancer
1 other identifier
interventional
34
1 country
4
Brief Summary
To evaluate the efficacy and safety of apatinib combined with adebrelizumab and EC in the first-line treatment of extensive small cell lung cancer
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jan 2025
Typical duration for phase_2
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 7, 2025
CompletedFirst Posted
Study publicly available on registry
January 22, 2025
CompletedStudy Start
First participant enrolled
January 25, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 25, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 25, 2028
January 22, 2025
January 1, 2025
2.5 years
January 7, 2025
January 20, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression free survival
Defined as the time from the start of enrollment to the date when objective tumor progression was first recorded or to death from any cause, whichever occurs first.
0ne year
Secondary Outcomes (4)
Objective remission rate
one year
Disease control rate
one year
Overall survival
2 years
Safety and tolerance evaluated by incidence, severity and outcomes of AEs
2 years
Study Arms (1)
Experimental group
EXPERIMENTALInterventions
100mg/m\^2 ivgtt for the first, second and third consecutive days, 21 days per cycle.
Day 1 administration, AUC=5, intravenous infusion; One treatment cycle every 21 days.
Eligibility Criteria
You may qualify if:
- \. Patients with extensive stage small cell lung cancer confirmed by histopathology or cytology (excluding complex small cell lung cancer);
- \. Age at the time of signing the informed consent: 18-75 years old (including 18 and 75 years old), male or female;
- \. The physical status of the Eastern Oncology Consortium (ECOG) was 0 or 1 (see Annex 1 for the ECOGPS scoring criteria);
- \. Have not received systematic treatment for extensive small cell lung cancer;
- \. Have at least one measurable lesion that meets the RECIST v1.1 standard (see Annex 3);
- \. Expected survival \>=3 months;
- \. If the major organs function normally, the following criteria are met:
- Blood routine test: hemoglobin (Hb) \>=90g/L; Absolute neutrophil count (ANC) \>=1.5×10\^9/L; Platelet (PLT) \>=100×10\^9/L; White blood cell count (WBC) \>= 3.0×10\^9/L;
- Biochemical examination: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \<=2.5×ULN (tumor liver metastasis, \<=5×ULN); Serum total bilirubin (TBIL) \<=1.5×ULN (Gilbert syndrome subjects, \<=3×ULN; In patients with liver metastasis, total bilirubin \<=3× ULN); Serum creatinine (Cr) \<=1.5×ULN or creatinine clearance \>=50ml/min;
- Coagulation function: activated partial thromboplastin time (APTT), International standardized ratio (INR), prothrombin time (PT) \<=1.5×ULN;
- Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF)\>=50%;
- \. BMS must be asymptomatic or treated and stable after discontinuation of steroids and anticonvulsants for at least 1 month prior to study therapy;
- \. Women of reproductive age should agree that they must use contraceptives (such as intrauterine devices \[IUD\], birth control pills or condoms) during the study period and for 6 months after the study ends; Have a negative serum pregnancy test within 28 days prior to study enrollment and must be a non-lactating subject; Men should be subjects who agree to use contraception during the study period and for 6 months after the end of the study period.
- \. Subjects voluntarily joined the study, signed informed consent, had good compliance, and cooperated with follow-up.
You may not qualify if:
- \. Known allergy to any of the drugs in the study;
- \. Previous or co-existing malignancies other than cured basal cell carcinoma of the skin, cervical carcinoma in situ, ductal carcinoma in situ of the breast (DCIS), papillary carcinoma of the thyroid gland, and other malignancies that have been adequately treated and cured for ≥5 years prior to the first dose with evidence of no recurrence or metastasis;
- \. Presence of symptomatic or active central nervous system (CNS) metastases or cancerous meningitis (patients with asymptomatic or stable brain metastases after treatment are allowed to be included);
- \. Active or previously suffering from autoimmune disease or immune deficiency;
- \. In the first study, patients with clinically significant bleeding symptoms or bleeding tendency, such as hemoptysis, hematemesis, hematochezia, gastrointestinal bleeding, hemorrhagic gastric ulcer, etc., occurred within 3 months before medication;
- \. Imaging (CT or MRI) shows that the tumor has invaded the large blood vessels or the boundary with the large blood vessels is unclear; Or if the investigator determines that the subject's tumor has a high risk of invading vital blood vessels during treatment and causing fatal bleeding;
- \. Have high blood pressure that is not well controlled by antihypertensive medication (systolic blood pressure \>= 150mmHg or diastolic blood pressure \>= 100 mmHg);
- \. Cardiovascular and cerebrovascular diseases of significant clinical significance:
- Cerebrovascular accident (excluding lacunar infarction, minor cerebral ischemia, or transient ischemic attack), myocardial infarction, unstable angina pectoris, and poorly controlled arrhythmias (including QTc interval \>= 450ms for men and 470 ms for women) occurred within 6 months before the first administration of the study drug (QTc interval \>= 450ms for women) Fridericia formula);
- New York Heart Association (NYHA) heart function Grade \> II or left ventricular ejection fraction (LVEF) \< 50%;
- \. Active or uncontrolled severe infection;
- Known human immunodeficiency virus (HIV) infection;
- Known history of clinically significant liver disease, including viral hepatitis \[active HBV infection, i.e., HBV DNA positive (\>1×104 copies /mL or \>2000 IU/ml) must be excluded for a known HBV carrier;
- Known hepatitis C virus infection (HCV) and HCV RNA positive (\>1×103 copies /mL), or other hepatitis, cirrhosis;
- \. Patients with uncontrolled pleural effusion, pericardial effusion or peritoneal effusion in the third space, as judged by researchers, requiring puncture and drainage; Or received ascites, pleural effusion drainage within 14 days before the first medication;
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Fujian Cancer Hospital
Fuzhou, Fujian, China
Fujian Provincial Hospital
Fuzhou, Fujian, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fuzhou, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 7, 2025
First Posted
January 22, 2025
Study Start
January 25, 2025
Primary Completion (Estimated)
July 25, 2027
Study Completion (Estimated)
September 25, 2028
Last Updated
January 22, 2025
Record last verified: 2025-01