Actively Recruiting
Pembrolizumab Plus Bevacizumab and Chemotherapy for ALK-rearranged NSCLC With Persistent 5'ALK
Led by Hunan Province Tumor Hospital · Updated on 2024-05-30
78
Participants Needed
1
Research Sites
141 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 ALK-rearranged Advanced Lung Adenocarcinoma with Persistent 5'ALK. The eligible patients should have Stage IV Adenocarcinoma ALK-rearranged tested by NGS Perisitent with 5'ALK Failed from first line Alectinib. The patients should meet the physical requirements to receive Pembrolizumab, Bevacizumab with Chemotherapy. All the patients who meet these requirements will be enrolled in this study. The eligible patients will be treated with Pembrolizumab 200 mg intravenously (IV) plus Bevacizumab 15mg/kg+ Pemetrexed 500mg/m2+Carboplatin AUC=4 for up to 4 cycles followed by Pembrolizumab 200mg Q3W+ Bevacizumab 15mg/kg+Pemetrexed 500mg/m2 for up to 31cycles or until disease progression, intolerable toxicity, or physician or participant decision.
CONDITIONS
Official Title
Pembrolizumab Plus Bevacizumab and Chemotherapy for ALK-rearranged NSCLC With Persistent 5'ALK
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older on day of signing informed consent
- Stage IV ALK-rearranged lung adenocarcinoma with persistent 5'ALK after first-line Alectinib failure
- At least one measurable lesion per RECIST 1.1 criteria suitable for target lesion selection
- Availability of formalin-fixed paraffin-embedded tissue samples or willingness to undergo biopsy
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Life expectancy of at least 3 months
- Adequate blood counts and organ function to receive study treatments
You will not qualify if you...
- Active or untreated central nervous system metastases
- Malignancies other than non-small cell lung cancer within 5 years prior to randomization, except those with negligible risk of metastasis or death after curative treatment
- Pregnant or lactating women
- Active autoimmune disease requiring systemic treatment in past 2 years
- History of certain lung diseases including idiopathic pulmonary fibrosis or pneumonitis
- Positive test for HIV
- Active hepatitis B or C infection
- Severe infection within 4 weeks before randomization
- Significant cardiovascular disease
- Any condition interfering with ability to understand or comply with study procedures
- Participation in another investigational treatment study within 4 weeks prior to first dose
- Prior treatment with anti-PD-1, anti-PD-L1 antibodies, or anti-VEGF agents
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hunan Cancer Hospital
Changsha, Hunan, China, 410013
Actively Recruiting
Research Team
Y
Yongchang C Zhang, MD
CONTACT
N
Nong C Yang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here