Actively Recruiting
A Phase II Study of AK112 (PD-1/VEGF Bispecific) in Combination with Chemotherapy for Patients with Advanced Non-squamous Non-small Cell Lung Cancer and Malignant Pleural Effusion
Led by Sichuan University · Updated on 2025-01-10
28
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of AK112, a PD-1/VEGF bispecific drug, with chemotherapy in patients who have stage IV non-squamous non-small cell lung cancer (NSCLC) with malignant pleural effusion. This phase II study aims to assess the effectiveness and safety of this treatment approach in this specific lung cancer population with an ECOG performance status of 0 to 2. Participants receive AK112 along with chemotherapy drugs Pemetrexed and either Carboplatin or Cisplatin on the first day of every three-week cycle for four cycles. After these initial cycles, they continue treatment with AK112 plus Pemetrexed until their disease progresses. This treatment schedule is designed to evaluate the combination's impact on cancer with malignant pleural effusion over time. During the study, participants will be monitored for tumor response using RECIST 1.1 criteria and assessed for objective response rate of malignant pleural effusion over approximately two years. Additional measurements include progression-free survival, overall survival rates, duration of response, and disease control rates. Safety monitoring and organ function assessments are also conducted throughout. The total participation period may last up to two years, with ongoing evaluation of treatment effects and patient health.
CONDITIONS
Brief Title
A Phase II Study of AK112 (PD1/VEGF Bispecific) in Combination with Chemotherapy in Patients with NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years at consent
- Histologically or cytologically confirmed diagnosis of stage IV non-squamous NSCLC
- Presence of malignant pleural effusion confirmed by cytology or CT imaging
- Negative for driver gene mutations
- Life expectancy of at least 3 months
- ECOG performance status of 0 to 2
- Adequate organ function
- Measurable disease based on RECIST 1.1 criteria
- Ability to provide formalin fixed, paraffin-embedded tumor tissue from biopsy
- Agreement to use effective contraception during and for 120 days after last treatment dose if of reproductive potential
- Ability and willingness to provide written informed consent and comply with study requirements
You will not qualify if you...
- Presence of small cell carcinoma components or squamous cell carcinoma as main tumor type
- Active malignancies within past 3 years except for study tumor or cured local tumors
- Current participation in another investigational agent or device study
- Active autoimmune disease requiring systemic treatment within 2 years prior to study
- Prior treatments targeting VEGFR
- Known active Hepatitis B or Hepatitis C infection
- History of recent serious heart conditions or vascular procedures within 12 months
- Major surgery within 30 days before first study treatment dose
- Use of live virus vaccine within 30 days prior to first study treatment
- Active autoimmune disease requiring systemic treatment in past 2 years except certain exceptions such as vitiligo or resolved childhood asthma/atopy
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.
Duration - Repeated 3-week cycles until disease progression or discontinuation
Participants receive AK112 plus chemotherapy on Day 1 of every 3-week cycle for 4 cycles followed by AK112 plus Pemetrexed until disease progression.
1 visit every 3 weeks for treatment
Trial Site Locations
Total: 1 location
1
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Actively Recruiting
Research Team
G
Ge Gao, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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