Actively Recruiting
Bevacizumab and Chemotherapy With or Without Pembrolizumab in First Line Alectinib Failed ALK-rearranged Advanced Lung Adenocarcinoma Patients With Persistent 5'ALK: A Phase II Randomized Control Trial
Led by Hunan Province Tumor Hospital · Updated on 2024-05-30
78
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of Pembrolizumab, Bevacizumab, and chemotherapy in people with advanced lung adenocarcinoma that has a specific ALK gene rearrangement and has not responded to first-line treatment with Alectinib. This phase II, open-label study is conducted at multiple centers and aims to see if this combination can improve progression-free survival in these patients. Eligible patients must have stage IV adenocarcinoma with persistent 5'ALK mutation confirmed by genetic testing and meet physical requirements to receive the treatments. Participants will be randomly assigned to one of two groups: one receiving Pembrolizumab 200 mg intravenously every three weeks plus Bevacizumab 15 mg/kg and chemotherapy (Pemetrexed 500 mg/m2 and Carboplatin) for up to four cycles, followed by maintenance therapy with Pembrolizumab, Bevacizumab, and Pemetrexed for up to 31 cycles or until disease progression or other reasons for stopping. The other group receives Bevacizumab plus chemotherapy without Pembrolizumab. Samples will be collected for advanced molecular testing to evaluate the tumor environment and predict treatment response. During the study, participants will undergo regular evaluations including imaging scans to measure tumor response and monitor side effects. Researchers will track progression-free survival as the primary outcome over two years, along with objective response rate and disease control rate. Safety and tolerability will be closely monitored throughout treatment. The total duration of participation varies depending on treatment response, progression, or participant decision. The study began in May 2024 and is expected to continue until February 2027.
CONDITIONS
Brief 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 the 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 suitable as a target lesion per RECIST 1.1 and not previously treated with palliative radiation
- Availability of at least 20 formalin-fixed paraffin-embedded (FFPE) slides or willingness to undergo biopsy for tissue sample
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of 3 months or more
- Adequate blood and organ function to receive study treatments
You will not qualify if you...
- Active or untreated central nervous system metastases
- Other malignancies within 5 years prior to randomization except those with negligible risk and curative treatment
- Pregnant or lactating women
- Active autoimmune disease requiring systemic treatment in the past 2 years
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or active pneumonitis on chest CT
- Positive test for human immunodeficiency virus (HIV)
- Active hepatitis B or hepatitis C infection
- Severe infection within 4 weeks prior to randomization
- Significant cardiovascular disease
- Conditions interfering with understanding or following study procedures
- Current participation or recent participation (within 4 weeks) in other investigational studies or therapies
- Prior treatment with anti-PD-1, anti-PD-L1, or anti-VEGF agents
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 21-day cycles until disease progression or discontinuation
Participants receive Pembrolizumab, Bevacizumab, and Chemotherapy or Bevacizumab with Chemotherapy to treat ALK-rearranged NSCLC with Persistent 5'ALK after Alectinib failure.
Visits every 21 days for treatment administration
Trial Site Locations
Total: 1 location
1
Hunan Cancer Hospital
Changsha, Hunan, China, 410013
Actively Recruiting
Research Team
Y
Yongchang C Zhang, MD
N
Nong C Yang, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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