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Adebizumab combined with bevacizumab and neoadjuvant chemotherapy for resectable non-small cell lung cancer: a multicenter, single-arm, prospective, exploratory clinical study

Adebizumab combined with bevacizumab and neoadjuvant chemotherapy for resectable non-small cell lung cancer: a multicenter, single-arm, prospective, exploratory clinical study

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300074313
Enrollment
Unknown
Registered
2023-08-03
Start date
2023-07-01
Completion date
Unknown
Last updated
2023-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-squamous non-small cell lung cancer

Interventions

Experimental group:Adebelimab + chemotherapy + bevacizumab

Sponsors

The First Affiliated Hospital of Anhui Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-75 years old, regardless of sex. two.. Resectable primary non-squamous non-small cell lung cancer in stage IIA-IIIB confirmed by histopathology or cytology (UICC/AJCC 8th edition). 3. Have not received local and systemic systemic treatment for primary lung cancer in the past. 4. At least one measurable lesion (according to RECIST 1.1). Negative driving genes such as 5.EGFR / ALK. 6.ECOG PS is 0 or 1. 7. Life expectancy = 3 months. 8. The functional level of organs must meet the following requirements: ANC = 1.5 × 10^9 / L; PLT = 90 × 10^9 / L × HB = 90 g; ALT and AST = 1.5×ULN, ALP = 2.5×ULN; BUN and Cr = 1 × ULN and creatinine clearance = 50 mL/min (Cockcroft-Gault formula); LVEF = 50%; QT interval (QTcF) corrected by Fridericia method: male < 450ms, female < 470ms;INR = 1.5×ULN, ACTT = 1.5×ULN. 9. The subjects signed an informed consent form and volunteered to participate in this study.

Exclusion criteria

Exclusion criteria: 1. Previous anti-tumor therapy for primary lung cancer, including chemotherapy, targeting, immunity or radiotherapy. two.. Subjects with allergic or hypersensitive constitution to therapeutic drugs, subjects with autoimmune diseases. 3. There is a third space effusion (such as massive pleural effusion and ascites) that cannot be controlled by drainage or other methods. 4. Use of steroids for more than 50 days, or long-term use of steroids. 5. Uncontrolled symptomatic brain metastasis or mental abnormalities that fail to correctly express subjective symptoms. 6. Other malignant tumors occur within 5 years before enrollment, except for cervical carcinoma in situ or squamous or basal cell carcinoma of the skin that have previously been treated for the purpose of radical treatment. 7. Pregnant and lactating women who are fertile but refuse to use contraception. 8. People with a history of severe heart disease or disease, including a recorded history of congestive heart failure, high-risk uncontrollable arrhythmias, angina pectoris requiring medication, clinically defined valvular heart disease, history of severe myocardial infarction and intractable hypertension. 9. Have received allogeneic tissue / solid organ transplantation. 10. According to the researchers' judgment, there are serious hazards to the safety of the subjects, or concomitant diseases that affect the subjects' completion of the study (such as uncontrolled hypertension, diabetes, thyroid diseases, etc.). 11.The researchers determined other situations that were not suitable for inclusion in the study.

Design outcomes

Primary

MeasureTime frame
Pathological complete remission rate;

Secondary

MeasureTime frame
Adverse event;Major pathological response rate;

Countries

China

Contacts

Public ContactRenquan Zhang

The First Affiliated Hospital of Anhui Medical University

1104370264@qq.com+86 135 0569 3475

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026