NSCLC
Conditions
Interventions
Test group:adaptive adjuvant sintilimab therapy guided by MRD
Sponsors
Chengdu Third People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Written informed consent obtained prior to the initiation of any trial-related procedures; 2. Male or female aged >=18 years and 6 months. 13. Sufficient organ function: - Absolute neutrophil count (ANC) >=1.5×10^9/L without the use of granulocyte colony-stimulating factor within the past 14 days. - Platelets >=100×10^9/L without transfusion within the past 14 days. - Hemoglobin >9 g/dL without transfusion or use of erythropoiesis-stimulating agents within the past 14 days. - Total bilirubin <=1.5×upper limit of normal (ULN). - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <=2.5×ULN (patients with liver metastasis are allowed to have ALT or AST <=5×ULN). - Serum creatinine <=1.5×ULN and creatinine clearance (calculated using the Cockcroft-Gault formula) =60 ml/min. - Good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) <=1.5×ULN. - Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within the normal range. Patients with baseline TSH outside the normal range are also eligible if total T3 (or FT3) and FT4 are within the normal range. - Cardiac enzyme spectrum within the normal range (patients with isolated laboratory abnormalities deemed clinically insignificant by the investigator are also eligible). 14. For women of childbearing potential, a negative urine or serum pregnancy test must be obtained within 3 days prior to the first administration of the study drug (Day 1 of Cycle 1). If the urine pregnancy test result is inconclusive, a serum pregnancy test is required. Postmenopausal women are defined as those who have been amenorrheic for at least 1 year, or have undergone surgical sterilization or hysterectomy. 15. All subjects (regardless of gender) who are at risk of conception must use contraception with a failure rate of less than 1% per year throughout the tre
Exclusion criteria
Exclusion criteria: 1. Diagnosis of any malignancy other than non-small cell lung cancer within 5 years prior to the first dose (excluding completely treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or carcinoma in situ that has been completely excised). 2. Received adjuvant radiotherapy prior to dosing. 3. Patients who have undergone pneumonectomy; 4. Currently participating in an interventional clinical study or received another investigational drug or used an investigational device within 4 weeks prior to the first dose; 5. Neoadjuvant treatment with anti-tumor therapies other than chemotherapy or immunotherapy; 6. Presence of unhealed surgical incisions, ulcers, or fractures; 7. In the investigator's opinion, severe concomitant systemic diseases that may affect the patient's ability to complete the study; patients with positive autoimmune antibodies must be assessed and confirmed by the investigator to not have autoimmune diseases requiring systemic therapy in order to be eligible; 8. Presence of primary immunodeficiency diseases; 9. Receipt of systemic corticosteroid therapy within 7 days prior to the first dose of the study (excluding topical corticosteroids administered via nasal, inhalation, or other local routes); Note: The use of physiologic doses of corticosteroids (=10 mg/day prednisone or equivalent) is permitted; 10. History of allogeneic organ transplantation (excluding corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 11. Known allergy to the active ingredient or excipients of the study drug, sintilimab; 12. Not fully recovered from toxicity and/or complications caused by any prior intervention (i.e., <=Grade 1 or returned to baseline, excluding fatigue or alopecia) prior to the start of treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year EFS rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| mOS;Evaluate the relationship between MRD status under landmark assessment and continuous monitoring and Event-Free Survival (EFS).;mEFS;2-year OS rate;Analyze the proportion of the four types of pathological response results based on irRVT (1%-5% irRVT vs. >5%-30% irRVT vs. >30%-80% irRVT vs. >80% irRVT), as well as their relationship with median Ev;To investigate the proportion of patients with sustained MRD-negative status and their median event-free survival (EFS).;AEs;QoL; | — |
Countries
China
Contacts
Public ContactYi Yang
Chengdu Third People's Hospital
Outcome results
None listed