NSCLC
Conditions
Interventions
PD-1 inhibitor:Sintilimab
Combination of PD-1 inhibitor and CTLA-4 inhibitor:Sintilimab combined IBI-310
PD-1/IL-2a dual antibody:IBI363
Combination of PD-1 inhibitor and CCR-8 inhibitor:Sintilimab combined LM-108
Sponsors
Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.The subject can understand the informed consent, voluntarily participate in and sign the informed consent; 2.The subject is >=18 years old on the date of signing the informed consent; 3.ECOG score 0 or 1; 4.Histologically or cytologically confirmed squamous or non-squamous NSCLC: Subjects with mixed NSCLC histological types must be classified as non-squamous or squamous based on the major histological components of the tumor; Subjects with mixed histological tumors containing both NSCLC and small cell lung cancer were not eligible to participate in the study. Participants with histological types of large cell neuroendocrine carcinoma, sarcomatoid carcinoma, or NSCLC-NOS were not eligible to participate in this study; 5.Patients evaluated by the investigators as having resectable clinical stage II-IIIB (N2 only) NSCLC patients (AJCC Edition 8) before neoadjuvant and receiving 3 to 4 courses of standard PD-1 monoclonal antibody combined with chemotherapy (platinum dual agent chemotherapy) during neoadjuvant therapy must have been completely resected NSCLC (no residual tumor and all surgical margins were negative). 6.Pathologic evaluation is required for MPR (less than 10% remaining tumor cells from the primary tumor) and specific response rate (1- surviving tumor/primary tumor). 7.Non-squamous non-small cell lung cancer with no EGFR mutation or ALK rearrangement or other driver gene positive for approved targeted drug therapy; Squamous non-small cell lung cancer with no known EGFR mutation or ALK rearrangement or other driver gene positive for approved targeted drug therapy; 8.The absence of disease recurrence was verified by chest CT(or PET-CT) and abdominal CT(B-ultrasound or PET-CT or MRI) during the 5 weeks prior to randomization; 9.Subjects must have recovered from surgery and neoadjuvant therapy (no grade 2 uncured toxicity) and be dosed less than 10 weeks after surgery; 10.Organ function within 10 days prior to initial administration meets the following criteria: • Bone marrow function: hemoglobin = 90 g/L; Absolute neutrophil count = 1.5 x 109/L; Platelet count = 100 x 109/L; • Kidney function: ? serum creatinine = 1.5 x ULN or serum creatinine clearance =60 mL/min (calculated according to the Cockcroft-Gault formula) • Liver function: Total bilirubin = 1.5 x ULN (total bilirubin =2.5 x ULN in subjects with Gilbert's syndrome or liver metastasis); Aminotransferase (ALT and AST) = 3 x ULN; • Coagulation function: INR or aPTT =1.5 x ULN; 11.Fertile female subjects must have a negative serum pregnancy test within 7 days prior to first dosing; 12.Fertile female subjects or male subjects with fertile partners agreed to use highly effective contraception (with an annual failure rate of less than 1%) from 7 days before the first dosing until 24 weeks after the end of dosing.
Exclusion criteria
Exclusion criteria: 1.Subjects who had only undergone segmentectomy or cuneiform resection, and patients who had not undergone systemic or lob-specific lymph node dissection; 2.Have received anti-tumor therapy outside the protocol (such as radiotherapy, chemotherapy, targeted therapy, other immunotherapy, etc.); Anti-tumor Chinese medicine treatment requires a 2-week washout period) ; 3.Severe grade 3 or higher irAE or severe organ damage occurred during neoadjuvant immunotherapy; 4.Past or current interstitial pneumonia/lung disease that requires systemic hormonal therapy; 5.Have a past or current autoimmune disease, Including, but not limited to, Crohn's disease, ulcerative colitis, systemic lupus erythematosus, sarcoidosis, Wegener syndrome (polyvasculitic granulomatosis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis), autoimmune hepatitis, systemic sclerosis (scleroderma, etc.), Hashimoto's thyroiditis (exceptions see below) Autoimmune vasculitis, autoimmune neuropathy (Guillain-Barre syndrome) and so on. The following conditions are excluded: Type I diabetes, hypothyroidism stable on hormone replacement therapy (including hypothyroidism due to autoimmune thyroid disease), psoriasis or vitiligo that does not require systemic treatment; 6.Concomitant with other malignancies within 5 years prior to initial administration and requiring active treatment, except for tumors that have been evaluated by the investigator to be cured; 7.The expected survival time is less than 3 months; 8.Have uncontrolled comorbidities, including but not limited to the following: • active HBV or HCV infection; Subjects who are HBsAg positive and/or HCV antibody positive during screening should be tested for HBV DNA and/or HCV RNA. Participants with HBV DNA=2000 IU/mL and/or HCV RNA negative were eligible for admission. HBsAg positive subjects should take antiviral drugs and monitor HBV DNA during treatment; • Known history of HIV infection or AIDS; • Active tuberculosis; • Active infection; 9.Previous history of allogeneic bone marrow or organ transplantation; 10.Uncontrolled hypertension (resting blood pressure =150/90 mmHg) in patients with known hypertension requires a steady dose of antihypertensive medication for 7 days prior to initial dosing; 11.Clinically significant cardiovascular diseases: These include cerebrovascular accident within 6 months, symptomatic cardiac insufficiency (NYHA II-IV), unstable angina or myocardial infarction within 6 months, or prolonged QTc or arrhythmia risk (baseline QTc>470 msec) , hypokalemia, long QT syndrome, resting heart rate >100 bpm atrial fibrillation or severe valvular disease); 12.A history of allergic reaction intolerance to antibody drugs (= grade 3 NCI-CTCAE v5.0); Any previous history of rapid allergic reactions, uncontrolled asthma (i.e., uncontrolled asthma symptoms on 3 or more of 3 or more features of partially controlled asthma); Prior apparent allergy to the drug (e.g. severe allergic reaction, immune-mediated hepatotoxicity, immune-mediated thrombocytopenia or anemia); 13.Pregnant and/or lactating women; 14.Other conditions that may affect the safety or compliance with the medication in this study include, but are not limited to, psychiatric disorders, uncontrolled large serous effusion, or moderate to large serous effusion requiring repeated drainage (recurring within 2 weeks after the intervention) such as pleural effusion, pericardial effusion, ascites, and dy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year DFS rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety evaluation;2-year OS rate; | — |
Countries
China
Contacts
Public ContactChang Chen
Shanghai Pulmonary Hospital
Outcome results
None listed