resectable stage IIA-IIIA non-small cell lung cancer
Conditions
Interventions
A group:Squamous cell carcinoma: Albumin paclitaxel 260mg/m2 + carboplatin AUC=5
D1,D22/D1D22D43/D1D22D43D64,2-4 cycles in total. For those who achieve PCR after surgery, continue to consolidate pembrolizumab immunotherapy for 1 year. For those who have not reached PCR after surge
A group:Non squamous cell carcinoma: Pemetrexed 500mg/m2 + AUC=5
D1,D22/D1D22D43/D1D22D43D64,2~4,2-4 cycles in total. For those who achieve PCR after surgery, continue to consolidate pembrolizumab immunotherapy for 1 year. For those who have not reached PCR after s
Sponsors
Jiangsu Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: a. The patient voluntarily participated in this study, signed an informed consent form, had good compliance, and cooperated with follow-up; b. Non small cell lung cancer patients confirmed by biopsy pathology; Wild-type driver gene; c. AJCC/UICC 9th edition stage IIA-IIIA resectable NSCLC patients, stage confirmed by EBUS-TBNA; d. Age greater than or equal to 18 years old and less than or equal to 75 years old, both male and female are eligible; e. ECOG score 0-1 points; f. There are measurable and/or unmeasurable lesions that meet the criteria for evaluating the efficacy of solid tumors (RECIST 1.1); g. Have not received any systemic anti-tumor therapy in the past (including but not limited to systemic chemotherapy, radiotherapy, molecular targeted drug therapy, immunotherapy, biological therapy, local therapy, and other research treatment drugs); h. The function of important organs meets the following requirements (no blood components or cell growth factors are allowed to be used 2 weeks before the screening examination begins): Absolute neutrophil count (ANC) = 1.5 × 109/L; Platelets = 100 × 109/L; Hemoglobin = 9g/dL; Serum albumin = 2.8g/dL; Total bilirubin = 1.5 × ULN, ALT, AST, and/or AKP = 2.5 × ULN; Serum creatinine = 1.5 × ULN or creatinine clearance rate = 60mL/min (calculated according to the Cockcroft Gault formula); International normalized ratio (INR) and activated partial thromboplastin time (APTT) = 1.5 × ULN (for stable dose anticoagulant therapy such as low molecular weight heparin or warfarin, and INR can be screened within the expected treatment range of anticoagulants); i. Female subjects with fertility should undergo a urine or serum pregnancy test within 72 hours before receiving the first dose of the study drug, and demonstrate a negative result, and be willing to use effective contraception methods during the trial period until 5 months after the last dose. For male participants whose partners are women of childbearing age, effective contraception methods should be used during the trial period and within 7 months after the last dose.
Exclusion criteria
Exclusion criteria: a. History of lung cancer surgery; b. History of malignant tumors other than prostate cancer; c. There is a high risk of respiratory bleeding, tracheal fistula, or tracheal perforation; d. Subjects with poor nutritional status, BMI less than 18.5kg/m2, or PG-SGA score = 9; e. Having undergone major surgery or suffered severe trauma within 4 weeks prior to the first use of the investigational drug; f. There are uncontrollable pleural effusion, pericardial effusion, or ascites that require repeated drainage; g. Previously received or currently receiving any of the following treatments: h. Anti-PD-1 or anti-PD-L1 antibody therapy, chemotherapy, radiotherapy, targeted therapy; i. Received any investigational drug within the first 4 weeks prior to the first use of the investigational drug; j. Subjects who require systemic treatment with corticosteroids (equivalent to>10mg of prednisone per day) or other immunosuppressive agents within 2 weeks prior to the first use of the investigational drug, except for the use of corticosteroids for pulmonary inflammation and prevention of allergies, nausea, and vomiting. Other special circumstances require communication with the sponsor. In the absence of active autoimmune diseases, inhalation or local use of steroids and corticosteroids with a dosage greater than 10mg/day of prednisone efficacy dose are allowed as substitutes for adrenal cortex hormones; k. Individuals who have received anti-tumor vaccines or have received live vaccines within 4 weeks prior to the first administration of the study drug; l. Suffering from any active autoimmune disease or history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism); Excluding vitiligo or patients with asthma/allergies of the same age who have already recovered and do not require any intervention in adulthood; Patients with autoimmune mediated hypothyroidism treated with thyroid replacement hormone at a stable dose and type I diabetes patients treated with insulin at a stable dose can be included; m. History of immunodeficiency, including HIV testing positive, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation and allogeneic bone marrow transplantation; n. Subjects with uncontrolled clinical symptoms or diseases of the heart, such as (1) NYHA II and above heart failure, (2) unstable angina, (3) myocardial infarction within 1 year, and (4) clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention; o. Within the first 4 weeks prior to the initial use of the investigational drug, there has been a severe infection (CTCAE>grade 2), such as severe pneumonia requiring hospitalization, bacteremia, infection complications, etc; Baseline chest imaging examination suggests the presence of active pulmonary inflammation and symptoms and signs of infection within 2 weeks prior to the first use of the study drug, requiring oral or intravenous antibiotic treatment, except for prophylactic use of antibiotics; p. History of interstitial lung disease, non infectious pneumonia, pulmonary fibrosis, or other uncontrolled acute lung diseases; q. Patients with active pulmonary tuberculosis infection detected through medical history or CT examination, or patients with a history of active pulmonary tuberculosis infection within the past year before enrollment, or patients wit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete remission rate, pCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progress-free survival, PFS;Overall Survival, OS;Major pathological response, MPR;Objective Response Rate, ORR;Safety; | — |
Countries
China
Contacts
Public ContactLi Ming
Jiangsu Cancer Hospital
Outcome results
None listed