Actively Recruiting
Cadonilimab in Patients (Pts) with Advanced Non-small Cell Lung Cancer (NSCLC)
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2025-01-27
44
Participants Needed
1
Research Sites
153 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase II trial studies how well cadonilimab combined with Bevacizumab and docetaxel work in treating patients with non-squamous and stage IV non-small cell lung cancer. Cadonilimab, a PD-1/CTLA-4 bispecific antibody, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Bevacizumab can regulate tumor microenvironment. Docetaxel was used in standard of care chemotherapy for non-small cell lung cancer, work to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving cadonilimab, bevacizumab and docetaxel together may work better in treating patients with non-squamous non-small lung cancer compared to standard of care.
CONDITIONS
Official Title
Cadonilimab in Patients (Pts) with Advanced Non-small Cell Lung Cancer (NSCLC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosed with locally advanced or metastatic (stage IIIB/IIIC or IV) non-squamous NSCLC confirmed by histology or cytology
- Disease progression after treatment with at most one PD-1/L1 inhibitor and platinum-based chemotherapy, with at least two cycles of PD-1/L1 inhibitor showing clinical benefit (progression-free survival of 3 months or more)
- No EGFR sensitizing mutations, EGFR T790M mutation, ALK gene fusion, ROS 1 gene rearrangement, or BRAF V600E mutation
- Measurable disease according to RECIST 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Life expectancy greater than 12 weeks
- At least one measurable lesion suitable for repeated accurate measurement
- Absolute neutrophil count (ANC) of 1500/uL or higher within 10 days before treatment
- Platelet count of 100,000/uL or higher within 10 days before treatment
- Hemoglobin level of 9.0 g/dL or higher within 10 days before treatment
- Creatinine clearance of 50 mL/min or higher
- Total bilirubin less than or equal to 1.5 times the upper limit of normal within 10 days before treatment
- AST and ALT less than or equal to 2.5 times the upper limit of normal (or 5 times for patients with liver metastases) within 10 days before treatment
- Serum albumin level of 28 g/L or higher
- INR and APTT less than or equal to 1.5 times the upper limit of normal
- Left ventricular ejection fraction of 50% or higher
- Male participants must agree to use contraception during treatment and for 120 days after the last dose, and avoid donating sperm during this time
- Female participants must not be pregnant or breastfeeding and either are not of childbearing potential or agree to use contraception during treatment and for 120 days plus one menstrual cycle after the last dose
You will not qualify if you...
- Prior treatment with tumor immune mechanism therapies other than anti-PD-1/L1 inhibitors for advanced NSCLC
- Previous exposure to docetaxel or bevacizumab
- Received systemic anti-tumor treatment within 3 weeks before starting the study
- Received TKI treatment, hormone anti-tumor treatment, palliative local treatment for non-target lesions, or non-specific immunomodulatory therapy within 2 weeks before starting the study
- Experiencing rapid or explosive disease progression
- Having any other active malignant tumors except NSCLC within 3 years before enrollment (except certain localized cancers considered cured)
- Active autoimmune diseases requiring systemic treatment in the past two years (excluding immune-related adverse events from PD-1/L1 inhibitors)
- Unable to swallow pills or have conditions affecting gastrointestinal absorption
- Active or past history of inflammatory bowel disease
- History of immune deficiency or positive HIV antibody test or long-term use of systemic corticosteroids or immunosuppressants
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China, 100000
Actively Recruiting
Research Team
X
Xifang Liu
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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