A Phase II Study of AK112 (PD1/VEGF Bispecific) in Combination with Chemotherapy in Patients with… (NCT06769295) | Clinical Trial Compass
RecruitingPhase 2
A Phase II Study of AK112 (PD1/VEGF Bispecific) in Combination with Chemotherapy in Patients with NSCLC
China28 participantsStarted 2025-02-01
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* 18 to 75 years old (at the time of inform consent obtained)ï¼›
* Have histologically- or cytologically-confirmed diagnosis of Stage IV non-squamas NSCLCï¼›
* The presence of malignant pleural effusion (positive pleural effusion cytology or multiple pleural nodules or thickening with pleural effusion on CT imaging)ï¼›
* Driver gene mutation negativeï¼›
* Have a life expectancy of at least 3 monthsï¼›
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2ï¼›
* Has adequate organ functionï¼›
* Have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessed by investigatorï¼›
* Be able to provide formalin fixed, paraffin-embedded (FFPE) tumor tissue obtained from either a core or excisional tumor biopsyï¼›
* All female and male subjects of reproductive potential must agree to use an effective method of contraception, as determined by the Investigator, during and for 120 days after the last dose of study treatmentï¼›
* Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures).
Exclusion Criteria:
* Histological or cytological pathology confirmed the presence of small cell carcinoma components, or the main component is squamous cell carcinomaï¼›
* Active malignancies within the past 3 years, with the exception of tumors in this study and cured local tumorsï¼›
* Is currently participating in a study of an investigational agent or using…