resectable stage IIA-IIIA non-small cell lung cancer
Conditions
Interventions
A group:Pemetrexed 500mg/m2+ carboplatin AUC=5
D1, D22
A group:Vometinib 80mg/ time orally, once a day, chemotherapy was started simultaneously, D1 ~ D49/56/63, until 1 week before surgery. Starting from 4 to 6 weeks after surgery, and no later than 8 wee
Sponsors
Jiangsu Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: a. Patients voluntarily participated in this study, signed informed consent, had good compliance, and cooperated with follow-up; b. Patients with lung adenocarcinoma confirmed by biopsy and pathology; EGFR gene mutation (19Del and/or 21 L858R); c. Patients with resectable lung adenocarcinoma with stage IIA-IIIA in AJCC/UICC 9th edition, whose stage was confirmed by EBUS-TBNA; d. Age = 18 years old, less than or equal to 75 years old, male or female; e. ECOG score 0-1; f. There are measurable and/or unmeasurable lesions that meet the definition of solid tumor response Evaluation Criteria (RECIST1.1); g. has not received any systemic anti-tumor therapy (including but not limited to systemic chemotherapy, radiotherapy, molecular-targeted drug therapy, immunotherapy, biotherapy, local therapy and other investigational therapeutic drugs); h. Vital organ function meets the following requirements (no blood components and cell growth factors are allowed 2 weeks before screening) : • 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 =60mL/min (calculated according to the Cockcroft-Gault formula); • International Standardized ratio (INR) and activated partial thromboplastin time (APTT) =1.5× ULN (for stable dose anticoagulants such as low molecular weight heparin or warfarin and INR can be screened within the intended therapeutic range of anticoagulants); i. Fertile female subjects should undergo a urine or serum pregnancy test that proves negative within 72 hours prior to receiving the initial study drug administration and be willing to use an effective method of contraception between the trial period and 5 months after the last dose. For male subjects whose partner is a woman of reproductive age, effective contraception should be used during the trial and for 7 months after the last dose.
Exclusion criteria
Exclusion criteria: a. History of lung cancer surgery; b. A history of malignancies other than prostate cancer; c. Has a higher 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. Major surgery or severe injury within 4 weeks prior to the first use of the study drug; f. The presence of uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage; g. Have previously received or are receiving any of the following treatment: h. Anti-pd-1 or anti-PD-L1 antibody therapy, chemotherapy, radiotherapy, targeted therapy; i. Received any investigational drug within 4 weeks prior to the first use of the investigational drug; j. Subjects with uncontrolled cardiac clinical symptoms or diseases, such as (1) NYHA II and above heart failure (2) unstable angina pectoris (3) myocardial infarction within 1 year (4) Clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention; o. Serious infections (CTCAE > Grade 2), such as severe pneumonia, bacteremia, and comorbiditis requiring hospitalization, occurred within 4 weeks prior to the first use of the investigatory drug; Baseline chest imaging indicated active pulmonary inflammation, signs and symptoms of infection within 2 weeks prior to the first use of the study drug requiring treatment with oral or intravenous antibiotics, except in cases of prophylactic antibiotic use; k. A history of interstitial lung disease, noninfectious pneumonia, pulmonary fibrosis, or other uncontrolled acute lung disease; l. Patients with a history of active pulmonary tuberculosis infection found through medical history or CT examination, or a history of active pulmonary tuberculosis infection within 1 year before enrollment, or a history of active pulmonary tuberculosis infection more than 1 year ago without formal treatment; m. subjects had active hepatitis B (HBV DNA=2000 IU/mL or 104copies/mL), hepatitis C (hepatitis C antibody positive and HCV-RNA above the lower limit of assay); n. Abnormal laboratory values of sodium, potassium and calcium greater than grade 1 existed within 2 weeks before randomization and could not be improved after treatment; o. Known allergy, hypersensitivity or contraindications to pemetrexed/carboplatin/volmetinib or any component used in their preparations; p. Malignancies other than prostate cancer that were diagnosed prior to the first use of the investigational drug, except malignancies with a low risk of metastasis and risk of death (5-year survival > 90%), such as adequately treated basal or squamous cell skin cancer or cervical carcinoma in situ; q. Pregnant or lactating women; The fertile subject is unwilling or unable to take effective contraceptive measures; r. As determined by the investigator, subjects have other factors that may cause them to be forced to terminate the study, such as other serious diseases (including mental illness) requiring co-treatment, recent co-existing serious diseases (such as myocardial infarction, cerebrovascular accident) considering high risk of recurrence, serious abnormalities in laboratory test values, family or social factors, etc. Circumstances that may affect the safety of subjects or the collection of test data.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological complete remission rate, pCR;Major pathological response, MPR;Stage decrease rate;Progression free survival, PFS; | — |
Countries
China
Contacts
Public ContactLi Ming
Jiangsu Cancer Hospital
Outcome results
None listed