Actively Recruiting
A Phase II Study of AK112 (PD1/VEGF Bispecific) in Combination with Chemotherapy in Patients with NSCLC
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
This is a phase II study. All patients are stage IV non-squamas non-small cell lung cancer(NSCLC) with malignant pleura effusion, Eastern Cooperative Oncology Group (ECOG) performance status 0-2. The purpose of this study is to evaluate the efficacy and safety of AK112 in combination with chemotherapy in patients with NSCLC with malignant pleura effusion.
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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Actively Recruiting
Research Team
G
Ge Gao, PhD
CONTACT
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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