NSCLC
Conditions
Interventions
Active Comparator Arm:Cisplatin(75mg/m2),and 500 milligrams per square meter (mg/m2) Pemetrexed
Sponsors
Cancer Hospital Chinese Acadmey of Medical Sciences, Shenzhen Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Objects over 18 years old (including 18 years old) and under 75 years old (including 75 years old); 2.Histologically confirmed as unresectable stage III NSCLC (according to AJCC eighth edition lung cancer staging standards); a. Unresectable stage III NSCLC includes some IIIA, IIIB and all IIIC stages, usually including single station N2 mediastinal lymph nodes with a short diameter >=3 cm or multiple stations and multi-station lymph nodes fused into clusters (lymph nodes on CT with a short diameter >=2 cm) N2 patients, T4 and all N3 patients invading the esophagus, heart, aorta, and pulmonary vein; 3. The stage III NSCLC diagnosed as unresectable has not received any systemic treatment or local treatment. 4. Tumor tissue samples or blood samples of stage III NSCLC diagnosed as unresectable are confirmed to be EGFR sensitive mutations (including exon 19 deletion or L858R, both alone or coexist with other EGFR mutations). ). If the tumor tissue is accessible, it is recommended to send the tumor tissue; if the tumor tissue is not accessible or the patient does not accept a tissue biopsy, take a blood sample for test; 5. Patients in the eastern tumor tissue cooperation group (ECoG) with a physical state score of 0 or 1 and no deterioration in the previous 2 weeks had a minimum expected survival of 12 weeks; 6. At least one tumor focus can be accurately measured at baseline, and the longest diameter at baseline is >= 10 mm (in case of lymph nodes, the shortest diameter is required to be >= 15 mm). The selected measurement method is suitable for accurate repeated measurement, which can be computed tomography (CT) or magnetic resonance imaging (MRI). If there is only one measurable lesion, it can be accepted as the target lesion. The baseline evaluation of tumor lesions should be conducted at least 14 days after the diagnostic biopsy; 7. Women of childbearing age need to take appropriate contraceptive measures and should not breastfeed 3 months after screening and stopping the research and treatment. Prior to the start of administration, the pregnancy test was negative, or one of the following criteria was met to demonstrate that there was no risk of pregnancy: (1) Postmenopause is defined as amenorrhea in patients over 50 years of age and at least 12 months after cessation of all hormone replacement therapy; (2) Women younger than 50 years old can also be considered as postmenopausal women if they have amenorrhea for 12 months or more after stopping all exogenous hormone treatment, and the levels of luteinizing hormone (LH) and follicle stimulating hormone (FSH) are within the laboratory postmenopausal reference values; (3) Subjects who had undergone irreversible sterilization, including hysterectomy, bilateral ovariectomy or bilateral salpingectomy, except for bilateral tubal ligation; 8. Barrier contraception (i.e. condom) should be used in male patients from screening to 3 months after discontinuation of study treatment; 9. The subject voluntarily participated and signed the informed consent in writing.
Exclusion criteria
Exclusion criteria: 1. Patients who relapse after surgery; 2. Non-newly diagnosed patients have previous treatment; 3. Have received any of the following treatments: (1) Have used any EGFR tyrosine kinase inhibitor in the past; (2) Any previous chemotherapy for lung cancer (3) Any previous radiotherapy for lung cancer (4) The patient had undergone major surgery within 4 weeks before the first administration of the study drug; (5) Within 7 days before the first administration of the study drug, CYP3A4 strong inhibitors, inducers, or drugs with a narrow therapeutic window for CYP3A4 sensitive substrates have been used. 4. Any concurrent and/or other active malignancy that has required treatment within 2 years of first dose of study drug; 5. Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 at the time of starting study treatment, with the exception of alopecia and Grade 2, prior platinum-therapy related neuropathy; 9. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension or active bleeding diatheses, which, in the Investigator's opinion, makes it undesirable for the patient to participate in the trial OR which would jeopardize compliance with the protocol such as active infection. Screening for chronic conditions is not required; 8. Any of the following cardiac criteria: (1) Mean resting corrected QT interval (QTc) > 470 ms obtained from 3 electrocardiograms (ECGs), using the screening clinic's ECG machine and Fridericia's formula for QT interval correction (QTcF); (2) Any clinically important abnormalities in rhythm, conduction, or morphology of the resting ECG (e.g., complete left bundle branch block, third-degree heart block, second-degree heart block, PR interval > 250 ms); (3) Any factors that increase the risk of QTc prolongation or risk of arrhythmic events, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval. (4) Left ventricular ejection fraction (LVEF) 2.5 ULN if no demonstrable liver metastases or > 5 ULN in the presence of liver metastases. (5) Aspartate aminotransferase (AST) > 2.5 ULN if no demonstrable liver metastases or > 5 ULN in the presence of liver metastases; (6) Total bilirubin (TBL) > 1.5 ULN if no liver metastases or > 3 ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or liver metastases; (7) Creatinine > 1.5 ULN concurrent with creatinine clearance 1.5 ULN; 12. Women who are breastfeeding or have a positive urine or serum pregnancy test at the Screening Visit. 13. History of hypersensitivity to any active or inactive ingredient of Almonertinib, or to drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;ORR;DCR;DoR;Safety; | — |
Countries
China
Contacts
Public ContactLvhua Wang
Cancer Hospital Chinese Acadmey of Medical Sciences, Shenzhen Center
Outcome results
None listed