Status:
NOT_YET_RECRUITING
Neoadjuvant Sintilimab Plus Anlotinib Therapy in IB-IIIB Resectable Non-small Cell Lung Cancer
Lead Sponsor:
Ningbo No.2 Hospital
Conditions:
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This is a prospective single-center, open-label, phase II study evaluating the efficacy of sintilimab plus anlotinib as a neoadjuvant regimen in the treatment of IB-IIIB resectable non-small cell lung...
Eligibility Criteria
Inclusion
- Providing written informed consent prior to initiating the study.
- Regardless of sex, aged ≥18 years and ≤75 years.
- Histologically confirmed NSCLC.
- At least one radiologically measureable lesion according to response evaluation criteria in solid tumors version 1.1(RECIST V1.1).
- Treatment-naïve IB-IIIB resectable NSCLC (American Joint Committee on Cancer 8th tumor-node-metastasis classification).
- Epidermal growth factor receptor(EFGR)/anaplastic lymphoma kinase(ALK)/ROS proto-oncogene 1(ROS1) wild type NSCLC.
- Absence of bleeding risk.
- Consent to surgical treatment.
- Indication for surgery confirmed by surgeons.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Expected survival time more than 6 months.
- Sufficient organ reserve, detailed as follows:(1) the absolute neutrophil count ≥1.5×109/L without the use of granulocyte colony-stimulating factor for the past 14 days prior to the first dose of study drugs;(2) platelet count ≥100×109/L without blood transfusion within the 2 weeks before the enrollment;(3) hemoglobin \>9g/dL without recent usage of blood transfusion 14 days prior to the study;(4) total bilirubin ≤ 1.5 fold the upper limit of normal (ULN), or total bilirubin \>1.5 fold ULN but direct bilirubin ≤ 1 fold ULN;(5) aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN;(6) blood creatinine ≤ 1.5 fold ULN and creatinine clearance (calculated by the Cockcroft-Gault formula) ≥ 60ml/min;(7) adequate coagulation function, defined by international normalized ratio (INR) or prothrombin time(PT) less than 1.5 fold ULN;(8) normal thyroid function defined by the normal range of thyroid-stimulating hormone (TSH); otherwise, abnormal level of TSH with normal range of T3(or Ft3) and Ft4;(8) cardiac enzyme profile within the normal limits (merely laboratory abnormity without clinical significance based on investigator's decision is allowed)
- For female participants of childbearing age, a urine or serum pregnancy test should be performed within 3 days before receiving the first dose of the study drugs, and the result must be negative. If the urine pregnancy test result is inconclusive, a blood pregnancy test is warranted. Postmenopausal women are defined as those who have been without menstruation for at least 1 year, or have undergone surgical sterilization or hysterectomy.
- In the presence of pregnancy risk, all participants (both male and female) are required to use contraceptive measures with an annual failure rate of less than 1% throughout the entire treatment period up to 120 days following the last dose of the study drugs.
Exclusion
- Exclusion criteria as follows：
- Other malignancy rather than NSCLC diagnosed within 5 years prior to the first dose of the study given, except for definitively treated basal cell carcinoma, squamous cell carcinoma of the skin, and/or in situ carcinoma.
- Enrolled in an ongoing interventional clinical trial, or receiving other study drugs or study medical devices within 4 weeks prior to the first dose of this study drugs.
- A history of receiving the following therapies: anti-programmed cell death-1 (anti-PD-1), anti-programmed cell death ligand-1 (anti-PD-L1) or anti-programmed cell death ligand-2 (anti-PD-L2) drugs, or drugs targeting T cell receptor (such as cytotoxic T-lymphocyte-associated protein 4, tumor necrosis factor receptor superfamily member 4 and CD137).
- A history of receiving targeted therapy such as anti-vascular endothelial growth receptor (VEGR)/ vascular endothelial growth factor receptor (VEGFR), rapidly accelerated fibrosarcoma(RAF), mitogen-activated protein kinase(MAPK), platelet-derived growth factor Receptor(PDGFR) or fibroblast growth factor receptor(FGFR).
- Receiving traditional Chinese medication or immunomodulatory drugs (including thymopentin, interferon, interleukin, except for controlling pleural effusion) as systemic therapy within 2 weeks prior to the first dose of the study drugs.
- Active systemic auto-immune disease requiring systemic treatment within 2 years prior to the first dose of the study drugs, such as the use of disease-modifying drugs, glucocorticoids or immunosuppressants. Alternative therapies (such as thyroid hormone, insulin, or physiological glucocorticoids used for adrenal or pituitary insufficiency) are not considered as systemic treatment.
- Systemic glucocorticoid therapy (excluding nasal, inhaled or other local routes of glucocorticoids) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drugs.
- Undergoing allogeneic organ transplant (excluding corneal transplantation) or allogeneic hematopoietic stem cell transplant.
- Allergy to the active ingredient or excipients of the study drug, sintilimab.
- Having not recovered from any toxicities and/or complications caused by prior interventions before the initiation of the study (i.e., ≤ Grade 1 or to baseline, excluding fatigue or hair loss)
- Known history of human immunodeficiency virus (HIV) infection.
- Untreated active hepatitis B (defined as hepatitis B surface antigen positive with detectable hepatitis B virus(HBV)-DNA copies exceeding the upper limit of normal values).
- Active hepatitis C infection.
- Receiving a live vaccine within 30 days prior to the first dose of the study drug.
- Pregnant or lactating women.
- Other investigator's defined uncontrolled systemic disease.
Key Trial Info
Start Date :
February 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2030
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06221462
Start Date
February 1 2024
End Date
February 1 2030
Last Update
January 25 2024
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.