Loading clinical trials...

A Phase II Study of AK112 (PD1/VEGF Bispecific) in Combination with Chemotherapy in Patients with NSCLC | Clinical Trials | Clareo Health

RECRUITINGPHASE2

A Phase II Study of AK112 (PD1/VEGF Bispecific) in Combination with Chemotherapy in Patients with NSCLC

A Phase II Study of AK112 (PD-1/VEGF Bispecific) in Combination with Chemotherapy for Patients with Advanced Non-squamas Non-mall Cell Lung Cancer and Malignant Pleural Effusion

NCT06769295•Sichuan University

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•18 to 75 years old (at the time of inform consent obtained)；
•Have histologically- or cytologically-confirmed diagnosis of Stage IV non-squamas NSCLC；
•The presence of malignant pleural effusion (positive pleural effusion cytology or multiple pleural nodules or thickening with pleural effusion on CT imaging)；
•Driver gene mutation negative；
•Have a life expectancy of at least 3 months；
•Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2；
•Has adequate organ function；
•Have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessed by investigator；
•Be able to provide formalin fixed, paraffin-embedded (FFPE) tumor tissue obtained from either a core or excisional tumor biopsy；
•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 treatment；
+1 more criteria

Exclusion Criteria

•Histological or cytological pathology confirmed the presence of small cell carcinoma components, or the main component is squamous cell carcinoma；
•Active malignancies within the past 3 years, with the exception of tumors in this study and cured local tumors；
•Is currently participating in a study of an investigational agent or using an investigational device;
•Active autoimmune disease requiring systemic treatment within 2 years prior to the start of study treatment；
•Subjects who received any prior treatments targeting VEGFR;
•Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA \[qualitative\] is detected);
•History of myocardial infarction, unstable angina, cardiac or other vascular stenting, angioplasty, or surgery within 12 months prior to day 1 of study treatment;
•Has undergone major surgery within 30 days prior to the first dose of study treatment;
•Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment NOTE: Subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study;
•Has received a live virus vaccine within 30 days prior to first dose of study treatment；

Locations (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Key Dates

Start Date

February 1, 2025

Primary Completion Date

December 31, 2026

Completion Date

December 31, 2027

Last Updated

January 10, 2025

Enrollment

ESTIMATED participants

Conditions

Lung Cancer, Non-Small Cell

Interventions

AK112

DRUG

Contacts

Ge Gao, PhD

CONTACT

86（028）85421606 gg1023@foxmail.com

Engagement of Veterans With Lung Cancer

NCT07219251

Lung Cancer (NSCLC)Lung Adenocarcinoma+4 more

View study

RECRUITINGPHASE1/PHASE2

Evaluation of Programmed Death Ligand 1 (PDL1) Response to Treatment in Extracellular Vesicles (EVs), Patient-derived Organoid (PDOs)s and Immune-marker Positron Emission Tomography (PET) Scanning in Non-small Cell Lung Cancer (NSCLC)

NCT06405230

Lung Cancer, Non-Small Cell

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 10, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Phase II Study of AK112 (PD1/VEGF Bispecific) in Combination with Chemotherapy in Patients with NSCLC

Inclusion Criteria

Exclusion Criteria

Engagement of Veterans With Lung Cancer

Evaluation of Programmed Death Ligand 1 (PDL1) Response to Treatment in Extracellular Vesicles (EVs), Patient-derived Organoid (PDOs)s and Immune-marker Positron Emission Tomography (PET) Scanning in Non-small Cell Lung Cancer (NSCLC)

Shared Decision Making on Radiation Dose for Lung Malignancies

Perioperative Tislelizumab for Resectable II-IIIB(N2) KRAS-mutated Nonsquamous Non-small Cell Lung Cancer

Radiolabelled Nectin-4 Targeted LMW Probe PET/CT in Patients With Lung Lesions

TIL Therapy Combined With Pembrolizumab for Advanced or Metastatic Refractory Lung Cancer