CTIS2024-511268-10-00进行中（未招募）1 期
Phase II clinical trial of AMG510 (Sotorasib) in stage III unresectable NSCLC KRAS p.G12C patients_MERIT-lung
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 43
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •1. Male or female, aged = 18 years old, 10. Patients with at least 1 measurable lesion, as defined by RECIST v1.1., 11. Adequate hematologic and organ function defined by the following laboratory results obtained within 14 days prior to enrolment: · Absolute neutrophil count (ANC) Neutrophils = 1500 cells/µL (without granulocyte colony-stimulating factor support within 10 days of laboratory test used to determine eligibility) · Lymphocyte count = 500/µL. · Platelet count = 100,000/µL (without transfusion within 2 weeks of laboratory test used to determine eligibility) · Haemoglobin = 9.0 g/dL (without transfusion within 2 weeks of laboratory test used to determine eligibility) · INR or aPTT = 1.5 × upper limit of normal (ULN). This applies only to patients who are not receiving therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be on a stable dose. · AST, ALT, and alkaline phosphatase = 2.5 times the upper limit of normal (ULN), except if alkaline phosphatase >2.5 times the ULN, then AST and/or ALT must be = 1.5 × ULN · Serum bilirubin = 1.0 × ULN. Patients with known Gilbert disease who have serum bilirubin level < 3 × ULN may be enrolled. · Serum creatinine = 1.5 × ULN, 12. All patients are notified of the investigational nature of this study and signed a written informed consent in accordance with institutional and national guidelines, including the Declaration of Helsinki prior to any trial-related intervention., 13. Willingness and ability to comply with scheduled visits and study procedures., 14. For female patients of childbearing potential, a negative pregnancy test must have been documented prior to enrolment (within 14 days prior to enrolment)., 15. For female patients of childbearing potential, agreement (by patient and/or partner) to use a highly effective form(s) of contraception that results in a low failure rate (< 1% per year) when used consistently and correctly, and to continue its use for 7 days after the last dose of AMG510 (Sotorasib). No hormonal methods and preferably barrier method always containing a spermicide, intrauterine device (IUD): intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner (on the understanding that this is the only one partner during the whole study duration), and sexual abstinence., 16. For male patients with female partners of childbearing potential, agreement (by patient and/or partner) to use a highly effective form(s) of contraception that results in a low failure rate [< 1% per year] when used consistently and correctly, and to continue its use for 7 days after the last dose of AMG510 (Sotorasib)., 17. Women who are not postmenopausal (= 12 months of non-therapy-induced amenorrhea) or surgically sterile must have a negative serum pregnancy test result within 14 days prior to enrolment., 18. QTc interval must be = 470 msec in females and = 450 msec in males, based on the average obtained from three ECG., 2. ECOG performance status of 0-1, 3. Histologically or cytologically confirmed, unresectable Stage III (IIIA, IIIB and IIIC) NSCLC according to 8th version of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology : a. Patients Stage III that did not respond to or progressed on to concurrent chemoradiotherapy could be included. Note: between 2-4 weeks should elapse between the end of radiotherapy and the start of Sotorasib b. Patients that did not respond or prog
排除标准
- •1. Patients with a known sensitizing mutation in the epidermal growth factor receptor (EGFR) gene, ALK translocations or ROS1 mutations, 10. Therapeutic oral or intravenous antibiotics within 2 weeks prior to enrolment, 11. Patients with any concomitant and uncontrolled medical disorder, 12. Patients with vena cava syndrome, 13. Malignant pleural or pericardial effusion: both will be considered as suggestive of metastatic disease. Also, are excluded those with negative cytology but being exudates. Patients with non-visible by thoracic X-ray pleural effusion or too small to be safely punctured could be included., 14. Malignancies other than NSCLC within 3 years prior to enrolment (except for adequately treated non-melanoma skin cancer, basal cell cancer, carcinoma in situ of the cervix, localized prostate cancer treated surgically with curative intent, which were allowed within 3 years), 15. Women who are pregnant, lactating, or intending to become pregnant during the study, 16. Positive test for HIV. All patients will be tested for HIV prior to inclusion into the study; patients who test positive for HIV will be excluded from the clinical study., 17. Patients with active hepatitis B (chronic or acute; defined as having a positive hepatitis B surface antigen [HBsAg] test at screening) or hepatitis C. -Patients with past hepatitis B virus (HBV) infection or resolved HBV infection (defined as the presence of hepatitis B core antibody [HBcAb] and absence of HBsAg) are eligible only if they are negative for HBV DNA. -Patients positive for hepatitis C virus (HCV) antibody are eligible only if PCR is negative for HCV RNA., 18. Active tuberculosis., 19. Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the patient at high risk from treatment complications., 2. Weight loss >10% within the previous 3 months, 20. Patients with illnesses or conditions that interfere with their capacity to understand follow and/or comply with study procedures., 21. Known or suspected hypersensitivity to drugs with similar chemical structures to the study drug, 22. Evidence of any other disorder or significant laboratory finding that makes the patient undesirable to participate in the study, 23. Use of strong inducers of CYP3A4 (including herbal supplements such as St John’s wort) within 14 days or 5 of half-lives (whichever is longer) prior to enrolment, 24. Use of proton pump inhibitors within 14 days to enrolment, 25. Previous treatment with sotorasib or other KRASG12C inhibitor, 3. Patients with uncontrolled neuropathy (sensory) grade 2 or greater regardless of cause according to CTCAE v5.0, 4. Major surgery within 28 days of enrolment, 5. Unresolved toxicities from prior anti-tumor therapy, defined as not having resolved to CTCAE version 5.0 grade 0 or 1, or to levels dictated in the eligibility criteria with the exception of alopecia (any grade allowed) or toxicities from prior anti-tumor therapy that are considered irreversible (defined as having been present and stable for > 6 months); endocrine adverse events that are stably maintained on appropriate replacement therapy are allowed, 6. Significant gastrointestinal disorder that results in significant malabsorption, requirement for intravenous alimentation, or inability
研究者
相似试验
招募中
2 期
A research study to evaluate the activity of Sotorasib for the treatment of patients with non-operable non-small cell lung cancer with a KRAS mutation2024-511268-10-00Fundacion GECP, Fundacion GECP19
招募中
2 期
Clinical Trial of AMG510 in Stage III Unresectable NSCLC KRAS p.G12C Patients and Ineligible for Chemo-radiotherapyNon-small Cell Lung Cancer Stage IIIKRAS P.G12CNCT05398094Fundación GECP19
进行中（未招募）
2 期
Testing the Use of AMG 510 (Sotorasib) and Panitumumab as a Targeted Treatment for KRAS G12C Mutant Solid Tumor Cancers (A ComboMATCH Treatment Trial)Advanced Malignant Solid NeoplasmMetastatic Malignant Solid NeoplasmNCT05638295National Cancer Institute (NCI)105
进行中（未招募）
不适用
A Phase 2, Open-label Study of AMG 706 to Treat Subjects with Locally Advanced or Metastatic Thyroid CancerTreatment of subjects with locally advanced or metastatic thyroid cancer.MedDRA version: 6.1Level: PTClassification code 10043744EUCTR2005-001618-42-ITAMGE88
招募中
2 期
SHERLOCK: Phase 2 trial of sotorasib in combination with carboplatin-pemetrexed and bevacizumab-biosimilar as first line treatment for advanced non-squamous non-small cell lung cancerwith KRAS G12C mutatioACTRN12622000973718The University of Sydney52