Actively Recruiting
Phase II Study of AK112 (PD-1/VEGF Bispecific) Combined with Chemotherapy in Advanced Non-Squamous Non-Small Cell Lung Cancer with Malignant Pleural Effusion
Led by Sichuan University · Updated on 2025-01-10
28
Participants Needed
1
Research Sites
151 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of AK112 combined with chemotherapy in patients with stage IV non-squamous non-small cell lung cancer (NSCLC) who have malignant pleural effusion. This phase II study includes participants with an ECOG performance status of 0 to 2 and aims to assess outcomes over approximately two years. The focus is on patients without driver gene mutations and with measurable disease confirmed by specific criteria. Participants receive AK112 together with Pemetrexed and either Carboplatin or Cisplatin on the first day of every 3-week cycle for four cycles. Following this, they continue treatment with AK112 plus Pemetrexed until the disease progresses. This treatment approach targets both PD-1 and VEGF pathways as part of the investigational therapy. During the study, participants will undergo regular assessments to monitor tumor response, side effects, and overall health. Researchers will collect tissue samples for analysis and ensure organ function remains adequate throughout treatment. The main outcome measured is the objective response rate of malignant pleural effusion, tracked for up to about two years, alongside safety evaluations and participant compliance with study procedures.
CONDITIONS
Official 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 time of consent
- Histologically or cytologically confirmed stage IV non-squamous NSCLC
- Presence of malignant pleural effusion confirmed by positive cytology or 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
- Use of effective contraception during and for 120 days after treatment for reproductive potential subjects
- Willingness and ability to provide informed consent and comply with study requirements
You will not qualify if you...
- Presence of small cell carcinoma components or main squamous cell carcinoma component
- Active malignancies within past 3 years except study tumors 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 myocardial infarction, unstable angina, vascular stenting, angioplasty, or surgery within 12 months prior to study
- Major surgery within 30 days prior to first dose
- Use of live virus vaccine within 30 days prior to first dose
- Systemic treatment for autoimmune disease in past 2 years (with noted exceptions for certain conditions)
AI-Screening
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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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