Non-small cell lung cancer
Conditions
Interventions
Group A-R:In the neoadjuvant stage, almonertinib (for 18 weeks) + pemetrexed + carboplatin (every 3 weeks, for 4 cycles) ? After image-based assessment ? If the tumor shrinks by more than 80%, randomi
Group A-S:In the neoadjuvant stage, almonertinib (for 18 weeks) + pemetrexed + carboplatin (every 3 weeks, for 4 cycles) ? After image-based assessment ? If the tumor shrinks by more than 80%, randomi
Group B-R:In the neoadjuvant stage, ensartinib (for 13 weeks) + pemetrexed + carboplatin (every 3 weeks, for 3 cycles) ? After image-based assessment ? If the tumor shrinks by more than 80%, randomiza
Group B-S:In the neoadjuvant stage, ensartinib (for 13 weeks) + pemetrexed + carboplatin (every 3 weeks, for 3 cycles) ? After image-based assessment ? If the tumor shrinks by more than 80%, randomiza
Group C-R:In the neoadjuvant stage, adebrelimab + pemetrexed/albumin-bound paclitaxel + carboplatin (every 3 weeks, for 3 cycles) ? After image-based assessment ? If the tumor shrinks by more than 80%
Group C-S:In the neoadjuvant stage, adebrelimab + pemetrexed/albumin-bound paclitaxel + carboplatin (every 3 weeks, for 3 cycles) ? After image-based assessment ? If the tumor shrinks by more than 80%
Sponsors
Jiangsu Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age should be above 18 years (inclusive) and below 75 years (inclusive). 2. The disease should be confirmed by pathological histology or cytology, and judged by the investigator to be stage II-III non-small cell lung cancer (according to the 8th edition of the International Lung Cancer Research Association's lung cancer staging system). 3. Tumor tissue samples or blood samples should be confirmed as NSCLC by the sponsor-approved laboratory tests. According to molecular pathology, it can be classified as: A - EGFR mutation group (i.e., 19 exon deletion or 21 exon L858R mutation, either alone or coexisting, with primary T790M mutation can be included, those with 20 exon insertion mutation or other rare mutations cannot be included); B - ALK mutation group (excluding immunohistochemical detection, it is recommended to perform NGS detection); C - immune group, except for the above mutations, all can be included in this group, and PDL-1 detection should be additionally performed. 4. According to the RECIST1.1 standard, the subjects must have at least one measurable lesion on imaging. The baseline imaging assessment of the tumor should be conducted within 28 days before the first administration of the study drug. 5. There should be no history of previous malignant tumors and no concurrent other malignant tumors, and no anti-tumor treatment has been received. 6. The Eastern Cooperative Oncology Group (ECOG) performance status score should be 0 or 1, and it should not have deteriorated within 2 weeks before the start of the study drug treatment. The expected survival period should be no less than 12 weeks. 7. For women of childbearing age, from the screening to the end of the study treatment, appropriate contraceptive measures should be taken and breastfeeding is not allowed. Before starting the medication, the pregnancy test should be negative, or one of the following criteria should be met to prove no pregnancy risk: a. Postmenopausal defined as an age greater than 50 years and amenorrhea for at least 12 months after discontinuation of all exogenous hormone replacement therapy; b. Women younger than 50 years old, if amenorrhea occurs after discontinuation of all exogenous hormone therapy for 12 months or more, and the levels of luteinizing hormone (LH) and follicle-stimulating hormone (FSH) are within the laboratory reference range for postmenopause, can also be considered postmenopausal; c. Those who have undergone irreversible sterilization surgery, including hysterectomy, bilateral oophorectomy or bilateral fallopian tube resection, but excluding bilateral tubal ligation. 8. For male subjects from the screening to the end of the study treatment, barrier contraception (i.e., condoms) should be used. 9. The subjects should voluntarily participate and sign the informed consent form in person.
Exclusion criteria
Exclusion criteria: 1. Any of the following conditions shall apply: a. Previous pulmonary surgery has been performed; b. Any EGFR tyrosine kinase inhibitor or ALK inhibitor has been used previously; c. Any systemic chemotherapy or immunotherapy targeting lung cancer has been received previously; d. Any radiotherapy for lung cancer has been received previously. 2. Within 14 days prior to the subject's use of the study drug, an open surgical procedure other than on the lungs has been performed. 3. Within the past 5 years, another malignant disease has been diagnosed (excluding completely resected basal cell carcinoma, in situ bladder cancer, and cervical in situ cancer). 4. Antitumor effects of traditional Chinese medicine have been used previously. If the use time was no more than 7 days and the subject has discontinued the medication for 2 weeks or more before the treatment with the study drug, they can be included. 5. There is evidence of severe or uncontrolled systemic diseases (such as severe mental, neurological disorders, epilepsy or dementia, unstable or non-compensatory respiratory, cardiovascular, liver or kidney diseases, left ventricular ejection fraction (LVEF) = 2 chronic heart failure. 9. Within 3 months, myocardial infarction, coronary artery/ peripheral artery bypass surgery or cerebrovascular accident has occurred. 10. QT interval (QTc) of 12-lead electrocardiogram for males >= 450 ms, for females >= 470 ms. 11. There are risk factors causing QT interval prolongation or increasing the risk of arrhythmia, such as heart failure, >=CTCAE (version 4.03) grade 2 hypokalemia (grade 2 hypokalemia defined as: serum potassium < lower limit of normal value - 3.0 mmol/L and with symptoms requiring treatment), congenital long QT syndrome, family history of long QT syndrome. 12. Within 2 weeks before the first administration, any known drug that prolongs the QT interval is being used. 13. Bone marrow reserve or organ function is insufficient, and meets any of the following laboratory limits (no corrective treatment within 1 week before laboratory tests): a. Absolute neutrophil count < 1.5 × 10^9 / L; b. Platelet count < 90 × 10^9 / L; c. Hemoglobin < 90 g/L (< 9 g/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event-free survival period; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease-free survival; overall survival ;organ preservation rate;complete pathological remission rate of the surgical group;primary pathological remission rate of the surgical group; | — |
Countries
China
Contacts
Public ContactYin Rong, Fan Chaohui, Shen Bo, Liu Yantian
Jiangsu Cancer Hospital
Outcome results
None listed