NCT06467617 Adebrelimab Plus Chemo and Recaticimab in Perioperative Treatment of Resectable NSCLC
| NCT ID | NCT06467617 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Beijing Chest Hospital, Capital Medical University |
| Condition | Non Small Cell Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 35 participants |
| Start Date | 2024-08-14 |
| Primary Completion | 2026-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 35 participants in total. It began in 2024-08-14 with a primary completion date of 2026-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Current studies confirmed that the immune perioperative treatment with combination chemotherapy curative effect and safety of resectable NSCLC, but its short-term curative effect and long-term survival benefit remains to be further improved to explore the new way of immune combination therapy. Experimental study showed that the inhibition of PCSK9 could significantly increase in tumor cells of the immune response in mice, inhibit the PCSK9 enhanced anti-tumor immune response of mice can be further coordinate with immune checkpoint therapy, forming a lasting anti-tumor immune effect. There are no reports on the peri-operative treatment of immune combined with chemotherapy and PCSK-9 inhibitors in patients with resectable NSCLC. Based on the above, the aim of this study is to explore the efficacy and safety of Adebrelimab combined with recaticimab and chemotherapy in the perioperative treatment of patients with resectable NSCLC.
Eligibility Criteria
Inclusion Criteria: 1. 18-75 years old, male and female; 2. ECOG PS 0-1; 3. Histologically or cytologically confirmed operable stage II-III NSCLC (stages II, IIIA, and T3N2M0 IIIB) according to the UICC and AJCC 8th edition TNM staging system. Non-massive metastases (short diameter ≤2cm Lymph nodes) with expected complete resectable N2; 4. With a measurable lesions (per RECIST 1.1 standard, tumor lesions on CT scan length to diameter 10 mm, or lymph node lesions on CT scans short diameter 15 mm or higher); 5. Anti-tumor treatment (radiotherapy, chemotherapy, surgery, and targeted therapy) naive enrollment; 6. Enough of lung function to go through R0 resection with a purpose of cure; 7. Normal main organs function, should meet the following criteria: (1) the blood routine examination shall meet within 14 days (without blood transfusion, hematopoietic factor not used and unused drugs to correct) a. ANC≥1.8 x 109 / L; B. Hb≥100 g/L; C. PLT ≥ 125×109/L; (2) Biochemical examination must meet the following criteria: a. TBIL ≤ 1.5ULN; B. ALT、AST≤2.5 ULN; Serum creatinine sCr≤1.5ULN, endogenous creatinine clearance≥50ml/min (Cockcroft-Gault formula) Exclusion criteria 1. Known EGFR or ALK mutation; 2. T4 tumors invading the heart, great vessels, trachea, recurrent laryngeal nerve, esophagus, vertebral body, tracheal carina, Upper sulcus lung cancer; 3. Use of immunosuppressive drugs within 4 weeks before the first dose of study drug, excluding nasal spray and inhaled corticosteroids or physiological doses of systemic steroids (i.e., ≤10 mg/day of prednisolone or other corticosteroids at physiological doses of equivalent drugs, with discontinuation of the drug for ≥1 week); 4. Received immunoregulatory effects of herbal medicine or Immune regulating effect of drugs (including thymosin, interferon, interleukin, except for local control Pleural effusion use) within 4 weeks before the first use of the study drug; 5. Malignant tumors other than NSCLC occurred within 5 years before enrollment. 6. Administered Live attenuated vaccine ≤ 4 weeks before the first dose or will be planned for the duration of the study； 7. Current are participating in clinical research and treatment of intrusive, or within 4 weeks before the first delivery received study drugs or other treatments; Not fully recovered from any intervention-related toxicity and/or complications before the first dose (i.e., ≤ grade 1 or baseline, excluding fatigue or alopecia)； 8. Severe infection (e.g., requiring intravenous antibiotics, antifungal or antiviral drugs) within 4 weeks before the first dose, or unexplained fever during screening/before the first dose. 38.5°C； 9. Have or suspected a history of pneumonia/interstitial lung disease or any lung disease that would interfere with pulmonary function testing; 10. With any active history of autoimmune disease or autoimmune diseases; Patients with complete remission of childhood asthma without any intervention in adulthood or with vitiligo were eligible; 11. With congenital or acquired immune function defects, such as human immunodeficiency virus (HIV) infection, active hepatitis B, hepatitis C, hepatitis B and hepatitis C infection together and alcoholic liver cirrhosis patients; 12. Patients with grade II or higher myocardial ischemia or myocardial infarction, poorly controlled arrhythmia (including QTc interval ≥450ms in men and ≥470ms in women). According to NYHA standard, grade III \~ Ⅳ cardiac insufficiency, or heart colour to exceed examination prompt left ventricular ejection fraction (LVEF) \< 50% into the group of the first six months happened myocardial infarction, heart failure, New York heart association class II or above has not been control angina pectoris, out of control of severe ventricular arrhythmia, with clinical significance of cardiac disease, Or abnormal electrocardiogram (ecg) indicate that acute ischemia or active conduction system; 13. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) more than 2 times the upper limit of normal value, or total bilirubin more than 1.5 times the upper limit of normal value (ULN); Creatine kinase (CK) was more than 3 times the upper limit of normal; There were major hemorrhagic events or arteriovenous thrombotic events 14. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 15. Known allergy, hypersensitivity, or intolerance to the study drug or its excipients; 16. Any condition considered by the investigator to be present that could harm the subject or cause the subject to be unable to meet or perform the requirements of the study.
Contact & Investigator
Jinghui Wang
STUDY CHAIR
Director of Research Laboratory, Beijing Chest Hospital
Frequently Asked Questions
Who can join the NCT06467617 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Non Small Cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06467617 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06467617 currently recruiting?
Yes, NCT06467617 is actively recruiting participants. Contact the research team at jinghuiwang2006@163.com for enrollment information.
Where is the NCT06467617 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06467617 clinical trial?
NCT06467617 is sponsored by Beijing Chest Hospital, Capital Medical University. The principal investigator is Jinghui Wang at Director of Research Laboratory, Beijing Chest Hospital. The trial plans to enroll 35 participants.
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