Pembrolizumab Plus Bevacizumab and Chemotherapy for ALK-rearranged NSCLC With Persistent 5'ALK

Launched by HUNAN PROVINCE TUMOR HOSPITAL · Mar 1, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a combination of three treatments—Pembrolizumab, Bevacizumab, and chemotherapy—to see if they can help patients with a specific type of lung cancer called advanced ALK-rearranged lung adenocarcinoma. This study is aimed at patients whose cancer did not respond to a previous treatment called Alectinib. To participate, patients must be at least 18 years old, have advanced cancer that can be measured, and meet certain health criteria.

Participants in this trial will receive the combination treatment for a set number of cycles, with the possibility of continuing for up to several years if their cancer does not get worse and they can tolerate the treatment. The trial is currently recruiting patients of all genders, and it aims to find out if this new treatment combination can improve how long patients live without their cancer progressing. It's important for potential participants to discuss any other health conditions or treatments they have had with their doctor, as there are specific eligibility requirements to ensure everyone’s safety during the study.

Gender

ALL

Eligibility criteria

• 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.