Efficacy and Safety of Sintilimab Combined With Platinum-containing Chemotherapy in Neoadjuvant Treatment of Resectable Stage ⅡB～ⅢA Non-small Cell Lung Cancer
Overview
- Phase
- Phase 2
- Intervention
- Sintilimab Combined with Platinum-containing Chemotherapy
- Conditions
- Non-small Cell Lung Cancer
- Sponsor
- The Second Affiliated Hospital of Shandong First Medical University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Major pathological remission
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
By exploring the feasibility, effectiveness and safety of neoadjuvant therapy with Sintilimab combined with platinum-containing chemotherapy in patients with resectable Stage ⅡB-ⅢA NSCLC, we will provide new treatment options and strategies for stage ⅡB-ⅢA NSCLC.
Detailed Description
The distant recurrence rate after radical surgery for early and partial locally advanced NSCLC is high, while the benefit degree of neoadjuvant chemotherapy is not satisfactory. The purpose of this study is to explore the feasibility, effectiveness and safety of neoadjuvant therapy with Sintilimab combined with platinum-containing chemotherapy in patients with resectable Stage ⅡB-ⅢA NSCLC. In addition to exploring the advantages of clinical efficacy of combination therapy, the analysis of biomolecular markers will be used to further understand the effects of combination therapy mode on immune activation and tumor immune microenvironment, and to explore potential biomarkers for predicting treatment response.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Sign written informed consent prior to implementing any trial-related procedures;
- •Male or female ≥18 years old and ≤75 years old;
- •Cytological or histological diagnosis of non-small cell lung cancer;
- •According to the efficacy evaluation criteria for solid tumors (RECIST version 1.1), at least one lesion can be measured on imaging;
- •Untreated stage ⅰ B - ⅲ A non-small cell lung cancer (TNM staging according to UICC/AJCC Edition 8);
- •Primary tumor can be biopsied;
- •Patients who agree to receive radical surgical treatment;
- •Patients who can be resected by surgeons and have no contraindications;
- •ECOG score 0-1;
- •Expected survival time \> 6 months;
Exclusion Criteria
- •Malignant diseases other than NSCLC were diagnosed within 5 years prior to first administration (excluding radical basal cell carcinoma of the skin, squamous carcinoma of the skin, and/or radical resected carcinoma in situ);
- •Are currently participating in an interventional clinical study or have been treated with another study drug or study device within 4 weeks prior to initial administration;
- •Prior treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs or drugs that target another stimulating or co-inhibiting T-cell receptor (e.g., CTLA-4, OX-40, CD137);
- •Received systemic systemic therapy with anti-tumor indications of Proprietary Chinese medicines or immunomodulatory drugs (including thymosin, interferon and interleukin, except for local use to control pleural effusion) within 2 weeks before the first administration;
- •An active autoimmune disease requiring systemic therapy (e.g., palliative drugs, glucocorticoids, or immunosuppressants) has occurred within 2 years prior to first dosing. Alternative therapies (e.g. thyroxine, insulin, or physiologic glucocorticoids for adrenal or pituitary dysfunction) are not considered systemic;
- •Were receiving systemic glucocorticoid therapy (excluding nasal spray, inhalation, or other topical glucocorticoid) or any other form of immunosuppressive therapy within 7 days prior to initial dosing; Note: Physiological doses of glucocorticoids (≤10 mg/ day of prednisone or equivalent) are permitted;
- •Allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation is known;
- •Those who are known to be allergic to the active ingredient or excipient of sindilizumab;
- •Has not fully recovered from toxicity and/or complications associated with any intervention prior to initiation of treatment (i.e., ≤ grade 1 or baseline, excluding fatigue or hair loss);
- •Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1/2 antibody positive);
Arms & Interventions
PD-1 inhibitor combined with chemotherapy
Sintilimab will be administered one day before platinum-containing chemotherapy.
Intervention: Sintilimab Combined with Platinum-containing Chemotherapy
Outcomes
Primary Outcomes
Major pathological remission
Time Frame: 3 years
Residual tumor cells were less than 10% in postoperative specimen pathology
Event-free survival
Time Frame: 3 years
The time from enrollment to occurrence of any event, including death, disease progression, change of chemotherapy regimen, change to chemotherapy, addition of other treatments, occurrence of fatal or intolerable side effects.
Secondary Outcomes
- Pathological complete remission(3 years)
- Disease-free survival(3 years)
- Overall Survival(3 years)
- Objective remission rate(3 years)