Actively Recruiting
Study of Cadonilimab with Bevacizumab and Docetaxel in Patients with Advanced Non-Small Cell Lung Cancer Phase II Trial for Patients Experienced with Checkpoint Inhibitors
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
Researchers are investigating how well cadonilimab combined with bevacizumab and docetaxel works in treating patients with advanced non-squamous stage IV non-small cell lung cancer (NSCLC) who have previously experienced checkpoint inhibitor therapy. Cadonilimab is a PD-1/CTLA-4 bispecific antibody that may help the immune system attack cancer and slow tumor growth. Bevacizumab aims to regulate the tumor environment, while docetaxel is a chemotherapy drug that stops tumor cells from growing or spreading. This phase II trial evaluates whether this combination works better than standard care for these patients. Participants receive cadonilimab intravenously over 90 minutes on day 1, along with bevacizumab given at 7.5 mg/kg IV and docetaxel at 60-75 mg/m2 IV over 60 minutes, also on day 1. These treatment cycles repeat every 21 days as long as the disease does not progress and side effects remain manageable. This regimen is designed to assess the combined effect of these drugs on advanced NSCLC. Throughout the study, patients will be monitored for disease progression and side effects, with evaluations based on a 6-month progression-free survival outcome. Researchers will measure tumor changes using standard criteria and ensure patient safety with laboratory tests and physical assessments. The study includes ongoing monitoring until disease progression or unacceptable toxicity occurs, giving a clear picture of how well the treatment controls cancer over time.
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
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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
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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