Non-Small Cell Lung Cancer
Conditions
Interventions
Therapy group:Adebrelimab combined with apatinib and platinum-based double-drug chemotherapy for neoadjuvant treatment for 3 cycles
Sponsors
Harbin Medical University Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18-75 years, male or female. 2. Diagnosis: Histologically or cytologically confirmed unresectable stage IIIA or IIIB non-small cell lung cancer (per the AJCC 8th edition staging system). 3. Prior Treatment: No previous anticancer treatments, including chemotherapy, immunotherapy, targeted therapy, or any other systemic anticancer therapy. 4. Performance Status: ECOG performance status of 0 or 1. 5. Measurable Disease: At least one measurable target lesion according to RECIST 1.1 criteria. 6. Life Expectancy: Greater than 3 months. 7. Adequate Organ Function: a) Hematological (without transfusion or growth factor support within 14 days): Hemoglobin (Hb) >= 90 g/L Absolute Neutrophil Count (ANC) >= 1.5 × 10?/L Platelet (PLT) >= 100 × 10?/L White Blood Cell Count (WBC) >= 3.0 × 10?/L b) Biochemical: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) = 50 mL/min c) Coagulation: Activated Partial Thromboplastin Time (APTT), International Normalized Ratio (INR), and Prothrombin Time (PT) = 50% as assessed by Doppler ultrasound. 8. Contraception: Women of childbearing potential must have a negative serum pregnancy test (ß-HCG) prior to initiation of treatment. All subjects of reproductive potential (including male partners) must agree to use highly effective contraception consistently during the treatment period and for 6 months after the last dose. 9. Informed Consent: Patients must voluntarily participate in the study and provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. EGFR/ALK Status: Known positivity for an activating EGFR mutation or ALK gene rearrangement. 2. Concurrent Malignancy: History of other active malignancies within the past 5 years, with the exception of adequately treated basal cell carcinoma of the skin, carcinoma in situ of the cervix, superficial bladder cancer, or other cancers considered cured. 3. CNS and Psychiatric Disorders: Uncontrolled symptomatic brain metastases. History of poorly controlled psychiatric disorders. Significant intellectual or cognitive impairment. 4. Autoimmune Disease: Patients with active, known, or suspected autoimmune diseases requiring systemic treatment in the past 2 years. However, subjects with hypothyroidism stable on hormone replacement, vitiligo, psoriasis, or alopecia not requiring systemic therapy are eligible. 5. Uncontrolled Concurrent Illness: Presence of any severe and/or poorly controlled medical condition, including: * a) Hypertension: Inadequately controlled hypertension (systolic blood pressure =150 mmHg or diastolic blood pressure =100 mmHg). * b) Cardiac Disease: >= Grade 2 myocardial ischemia or infarction, arrhythmias (including QTcF interval =450 ms in males or =470 ms in females), or = Grade 2 congestive heart failure (per New York Heart Association (NYHA) criteria). 6. Contraindications: Known hypersensitivity to any component of the investigational product. Central lung squamous cell carcinoma or lesions invading major blood vessels with a high risk of massive hemoptysis. Severe hepatic or renal dysfunction. Pregnancy or lactation. 7. Wounds/Fractures: Presence of severe, non-healing wounds, active ulcers, or untreated bone fractures. 8. Effusions: Poorly controlled pleural effusion, pericardial effusion, or ascites requiring frequent therapeutic drainage. 9. Bleeding/Coagulopathy: History of bleeding diathesis or significant coagulopathy. 10. Impairment of Drug Intake: Any condition that would substantially impair the absorption of oral medications (e.g., inability to swallow, major gastrointestinal resection, chronic diarrhea, intestinal obstruction). 11. Substance Abuse: History of substance abuse, alcohol abuse, or drug addiction. 12. Active Hepatitis: Hepatitis B: HBsAg positive with HBV DNA levels above the upper limit of normal (ULN). Hepatitis C: Anti-HCV antibody positive with HCV RNA levels above the ULN. 13. HIV: Positive test for Human Immunodeficiency Virus (HIV 1/2 antibodies). 14. Compliance: Inability to comply with the study protocol or cooperate with scheduled follow-up visits. 15. Investigator Discretion: Any other condition deemed by the investigator to make the patient unsuitable for study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Surgical resection rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological complete response rate;Major pathological response rate;Disease Control Rate;Objective response rate;Overall survival;Safety; | — |
Countries
China
Contacts
Public ContactYang Maopeng
Harbin Medical University Cancer Hospital
Outcome results
None listed