Status:
RECRUITING
Pembrolizumab Plus Bevacizumab and Chemotherapy for ALK-rearranged NSCLC With Persistent 5'ALK
Lead Sponsor:
Hunan Province Tumor Hospital
Conditions:
ALK Gene Mutation
Lung Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is an open-label, multiple centers, two-arms phase II study to evaluate the safety and efficacy Pembrolizumab,Bevacizumab in combination with Chemotherapy could improve PFS in Alectinib Failed AL...
Detailed Description
This is an open-label, multiple centers, two-arms phase II study to evaluate the safety and efficacy Pembrolizumab,Bevacizumab in combination with Chemotherapy could improve PFS in Alectinib Failed AL...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 29 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 16 2027
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT05266846
Start Date
May 29 2024
End Date
February 16 2027
Last Update
May 30 2024
Active Locations (1)
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1
Hunan Cancer Hospital
Changsha, Hunan, China, 410013