non-small cell lung cancer
Conditions
Interventions
Intervention group:Sintilimab: 100 mg (10 mL) per vial, 2 vials per administration (total of 17 administrations). Ipilimumab: 1 mg/kg, administered by intravenous infus
Sponsors
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age >= 18 years; 2.According to the AJCC 9th edition guidelines, histologically or cytologically confirmed squamous or non-squamous NSCLC, resectable clinical stage II, IIIA, or IIIB (with lymph node involvement [N2]); 3.It has been confirmed that EGFR-targeted or ALK-targeted therapy is not suitable as the primary treatment. Note: If the subject’s tumor histology is predominantly squamous cell carcinoma, molecular testing for EGFR or ALK mutations is not required; 4.After consultation with a surgeon, the subject is assessed by the investigator as eligible for surgery; 5.Able to receive neoadjuvant therapy with sintilimab in combination with platinum-based doublet chemotherapy. Note: Subjects who previously received 3–4 cycles of sintilimab combined with platinum-based chemotherapy as neoadjuvant treatment outside the study and successfully completed surgery are eligible; 6.ECOG performance status of 0–1; 7.Achieved R0 or R1 resection status; 8.Pathological review shows that pathological complete response (pCR) was not achieved at surgery; 9.Re-baseline imaging evaluation within 28 days before postoperative adjuvant therapy, using contrast-enhanced CT (or MRI) of the chest/abdomen/pelvis, confirms no evidence of disease; 10.Able to continue receiving adjuvant therapy with sintilimab; 11.Expected survival time > 6 months; 12.Adequate organ function: (1). Hematology: absolute neutrophil count (ANC) >= 1.5 × 10^9/L;platelet count (PLT) >= 70 × 10^9/L;hemoglobin (HGB) >= 90 g/L; (2).Liver function: total bilirubin (TBIL) = 28 g/L;alkaline phosphatase (ALP) = 50 mL/min (calculated using the standard Cockcroft-Gault formula); (4) Coagulation function: international normalized ratio (INR) <= 1.5, or PT <= 1.5 × ULN, aPTT <= 1.5 × ULN. For subjects receiving anticoagulant therapy, PT and INR should be within the therapeutic range of the anticoagulant; 13.Voluntary participation in the study with signed informed consent. If the subject is unable to read or sign the informed consent due to incapacity, a legal guardian must complete the consent process and sign on their behalf. If the subject is unable to read (e.g., illiterate), a witness must be present during the consent process and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1.Presence of any of the following tumor sites/types: (1). NSCLC involving the superior sulcus (Pancoast tumor) ;(2). Large cell neuroendocrine carcinoma (LCNEC) ;(3). Sarcomatoid tumors d) Diagnosis of SCLC or mixed tumors containing a small cell component; 2.Active inflammatory bowel disease requiring immunosuppressive therapy, or a history of inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis, or chronic diarrhea); 3.Uncontrolled significant cardiovascular or cerebrovascular disease, including but not limited to New York Heart Association (NYHA) Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmias, QTcF interval prolongation >480 ms, and/or other severe cardiovascular or cerebrovascular diseases occurring within 6 months prior to study intervention; 4.Prior receipt of neoadjuvant therapy for the current NSCLC diagnosis; 5.Prior treatment with anti–PD-1, anti–PD-L1, or anti–PD-L2 agents, or drugs targeting other stimulatory or co-inhibitory T-cell receptors (e.g., CTLA-4, OX40, CD137); 6.Receipt of systemic anti-tumor therapy, including investigational drugs, within 4 weeks prior to the first dose of study intervention; 7.Receipt of radiotherapy within 2 weeks prior to initiation of study intervention, or presence of radiation-related toxicity requiring corticosteroid treatment; 8.Receipt of live or attenuated live vaccines within 30 days prior to the first dose of study intervention. Inactivated vaccines are permitted; 9.Use of investigational drugs or devices within 4 weeks prior to study intervention; 10.Known other malignancy that has progressed or required active treatment within the past 5 years. Note: Subjects with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (excluding carcinoma in situ of the bladder) that have undergone potentially curative treatment are not excluded. Subjects with low-risk early-stage prostate cancer (T1–T2a, Gleason score =6, PSA <10 ng/mL) are not excluded if they have received definitive treatment or are under active surveillance due to stable disease; 11.Severe hypersensitivity (Grade =3) to the study intervention, any of its excipients, and/or other biologic therapies; 12.Active autoimmune disease requiring systemic treatment within the past 2 years. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroids) is permitted; 13.History of (non-infectious) pneumonitis/interstitial lung disease requiring steroid treatment, or current pneumonitis/interstitial lung disease; 14.Active infection requiring systemic therapy; 15.HIV-infected subjects with a history of Kaposi’s sarcoma and/or multicentric Castleman disease; 16.Concurrent active hepatitis B virus infection (defined as HBsAg positive and/or detectable HBV DNA) and hepatitis C virus infection (defined as anti-HCV antibody positive and detectable HCV RNA). Note: Screening for hepatitis B and C is not required unless: (1).There is a known history of HBV or HCV infection ;(2).Required by local health regulatory authorities 17.Diagnosis of immunodeficiency, or receipt of chronic systemic steroid therapy (exceeding 10 mg/day prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug; 18.History of allogeneic tissue or solid organ transplantation; 19.Incomplete recovery from major surgery or presence of ongoing surg
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year disease-free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability;2-year survival rate; | — |
Countries
China
Contacts
Public ContactZhengfu He
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Outcome results
None listed