non-small cell lung cancer
Conditions
Interventions
Escalation Immunotherapy for MRD-positive:Adjuvant immunotherapy plus chemotherapy
Standard Immuntherapy for MRD-positive :Adjuvant Immunotherapy
De-escalation Immunotherapy for MRD-negative:Follow-up
Standard Immuntherapy for MRD-negative:Adjuvant Immunotherapy
Sponsors
Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1 Sign a written informed consent before undergoing any trial-related procedures; 2 Male or female aged >=18 years and 6 months; 10 Adequate organ function, with participants required to meet the following laboratory criteria: 1) Absolute neutrophil count (ANC) >=1.5x10^9/L without the use of granulocyte colony-stimulating factors in the past 14 days. 2) Platelets >=100×10^9/L without transfusion in the past 14 days. 3) Hemoglobin >9g/dL without transfusion or use of erythropoietin in the past 14 days; 4) Total bilirubin ULN but direct bilirubin =60 ml/min; 7) Good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) <=1.5 times ULN; 8) Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within the normal range, If baseline TSH is outside the normal range, participants with total T3 (or free T3) and free T4 within the normal range may also be enrolled; 9) Normal myocardial enzyme profile (laboratory abnormalities considered clinically insignificant by the investigator are also allowed for enrollment); 11 For female participants of childbearing potential, a urine or serum pregnancy test must be performed within 3 days before the first administration of the study drug (Cycle 1, Day 1) and the result must be negative, If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required, Non-childbearing potential is defined as postmenopausal for at least 1 year, or having undergone surgical sterilization or hysterectomy; 12 If there is a risk of pregnancy, all participants (both male and female) must use contraceptive measures with an annual failure rate of less than 1% throughout the treatment period until 120 days after the last administration of the study drug (or 180 days after the last chemotherapy drug administration).
Exclusion criteria
Exclusion criteria: 1Diagnosis of other malignant diseases, excluding non-small cell lung cancer, within 5 years prior to the first dose (excluding skin basal cell carcinoma, squamous cell carcinoma of the skin, and/or in situ carcinoma after radical resection); 2Currently participating in an interventional clinical treatment study, or having received other investigational drugs or treatments with investigational devices within 4 weeks prior to the first dose; 3Previous treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs, or drugs targeting another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137); 4Receipt of Chinese herbal medicines with anti-tumor indications or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use to control pleural effusion) within 2 weeks prior to the first dose of systemic treatment; 5A history of active autoimmune disease requiring systemic treatment (e.g., use of disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapies (e.g., thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) are not considered systemic treatment; 6Currently receiving systemic corticosteroid treatment (excluding nasal, inhaled, or other locally administered corticosteroids) or any other form of immunosuppressive therapy within 7 days prior to the first dose of the study; 7Note: The use of physiological doses of corticosteroids (<=10 mg/day of prednisone or equivalent and the use of corticosteroids for pre-treatment of chemotherapy) is permitted; 8Known history of allogeneic organ transplantation (excluding corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 9Known hypersensitivity to the active ingredient or excipients of the study drug PD-1; 10Not having fully recovered from toxicity and/or complications caused by any intervention (i.e., <= Grade 1 or baseline, excluding fatigue or hair loss) before the start of treatment; 11Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive); 12Untreated active hepatitis B (defined as HBsAg positive with HBV-DNA copy number greater than the upper limit of normal as determined by the laboratory of the participating research center); Note: Hepatitis B subjects meeting the following criteria may also be enrolled:HBV viral load <1000 copies/ml (200 IU/ml) before the first dose, and the subject should receive anti-HBV treatment throughout the chemotherapy treatment period to avoid viral reactivation 1)For subjects who are anti-HBc (+), HBsAg (-), anti-HBs (-), and HBV viral load (-), no prophylactic anti-HBV treatment is required, but close monitoring for viral reactivation is necessary 2)Active hepatitis C virus (HCV) infection (HCV antibody positive with HCV-RNA levels above the limit of detection); 13Vaccination with a live vaccine within 30 days prior to the first dose (Cycle 1, Day 1); Note: Inactivated viral vaccine injections for seasonal influenza are allowed within 30 days before the first dose; however, intranasal attenuated live influenza vaccine is not permitted. 14Pregnant or lactating women; 15Presence of any serious or uncontrolled systemic disease, such as: 1)Significant and symptomatic difficult-to-control abnormalities in rhythm, conduction, or morphology on resting ECG, such as complete left bundle branch block, second-degree or higher heart block, ventricular arrhythmi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3 year Disease-free survival(DFS) ratio; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival period;Pathologic Complete Response(pCR);Safety; | — |
Countries
China
Contacts
Public ContactYang Bo
Chinese PLA General Hospital
Outcome results
None listed