Yükleniyor... / Loading...
Pembrolizumab Plus Bevacizumab and Chemotherapy for ALK-rearranged NSCLC With Persistent 5'ALK
Bu çalışma, kalıcı 5'ALK bulunan ve ALK yeniden düzenlenmesi taşıyan küçük hücreli dışı akciğer kanseri (non-small cell lung cancer, NSCLC) hastalarında Pembrolizumab ile Bevacizumab ve kemoterapinin birlikte kullanımını değerlendirmektedir. Çalışmaya, birinci basamak Alectinib tedavisi sonrası hastalığı ilerlemiş, evre IV, 18 yaş ve üzeri hastalar alınmaktadır. Faz 2 aşamasında yürütülmekte ve halen katılımcı almaktadır.
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
Inclusion Criteria:
* Age ≥ 18 years of age on day of signing informed consent.
* Stage IV ALK-rearranged Lung Adenocarcinoma Persistent with 5'ALK Failed from first line Alectinib
* Have at least 1 lesion that meets the criteria for being measurable, as defined by RECIST 1.1, and is appropriate for selection as a target lesion, as determined by local site investigator radiology review. Lesions that appear measurable, but have undergone palliative irradiation, cannot be target lesions ④20 FFPE sliders prepared,Subjects who do not have histology samples (defined as core or excisional biopsy, or resections) will need to undergo a new biopsy to provide a tissue sample ⑤Eastern Cooperative Oncology Group performance status 0 or 1
* Life expectancy ≥3 months
* Adequate hematologic and end organ function
Exclusion Criteria:
Cancer-Specific Exclusions:
①Active or untreated central nervous system metastases
②Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome
General Medical Exclusions:
* Pregnant or lactating women.
* Has active autoimmune disease that has required systemic treatment in the past 2 years.
* History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
* Positive test for human immunodeficiency virus.
⑤Active hepatitis B or hepatitis C.
⑥Severe infection within 4 weeks prior to randomization .
⑦Significant cardiovascular disease.
⑧Illness or condition that interferes with the participant's capacity to understand, follow and/or comply with study procedures.
⑨Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment for another health-related problem.
Exclusion Criteria Related to Medications: Prior treatment with anti-programmed death-1, anti-PD-L1 therapeutic antibodies，and anti-VEGF agents.