BridgeMD
New treatment option for Lung Cancer, Non-Small Cell
Official title A Phase II Study of AK112 (PD1/VEGF Bispecific) in Combination with Chemotherapy in Patients with NSCLC
ClinicalTrials.gov ID: NCT06769295
What this study is testing
What is AK112?
AK112 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for lung cancer, non-small cell.
Also referred to as Pemetrexed, Carboplatin/Cisplatin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- Driver gene mutation negative；
- Have a life expectancy of at least 3 months；
You likely can't join if
- 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；
- people 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);
See the full eligibility 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 people 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；
- Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures).
- 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；
- people 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...
- Has received a live virus vaccine within 30 days prior to first dose of study treatment；
The study team makes the final eligibility decision.
Where it's taking place
- Chengdu, Sichuan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chengdu, Sichuan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.