Actively Recruiting
A Prospective, Open-label, Single-center, Single-arm Phase II Clinical Study of Cadonilimab (AK104) Combined With Monotherapy Chemotherapy in Patients With Advanced Non-small Cell Lung Cancer With Negative Driver Genes and Failed Immunotherapy
Led by Xin-Hua Xu · Updated on 2024-06-21
48
Participants Needed
1
Research Sites
147 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The aim of evaluating the efficacy and safety of cadonilimab combined with monotherapy chemotherapy in patients with advanced non-small cell lung cancer (NSCLC) with negative driver genes who have failed previous immunotherapy is to provide a more effective and safe treatment option for these patients.
CONDITIONS
Official Title
A Prospective, Open-label, Single-center, Single-arm Phase II Clinical Study of Cadonilimab (AK104) Combined With Monotherapy Chemotherapy in Patients With Advanced Non-small Cell Lung Cancer With Negative Driver Genes and Failed Immunotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily participate and sign informed consent
- Age between 18 and 75 years, male or female
- ECOG performance status of 0 to 2
- Histologically confirmed advanced non-small cell lung cancer (squamous or non-squamous)
- Negative for driver genes after genetic testing
- Previous systemic therapy with failed anti-PD-1/PD-L1 immunotherapy
- At least one measurable lesion by RECIST 1.1
- Liver function within specified limits
- Renal function within specified limits
- Adequate blood counts and hemoglobin levels
- Expected survival longer than 3 months
You will not qualify if you...
- ECOG performance status greater than 2
- Prior treatment with bispecific antibodies
- Participation in other clinical trials within 30 days
- Brain or leptomeningeal metastasis
- History of other malignancies except certain cured cancers
- Serious diseases such as uncontrolled heart failure, unstable angina, arrhythmia, hypertension, severe infection, uncontrolled diabetes, or mental illness
- Allergy to study drugs or ingredients
- Pregnant or breastfeeding, or unwilling/unable to use contraception
- Investigator deems participation inappropriate
- Unwilling or unable to sign informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of Medical Oncology, Central Hospital of Yichang City, the First Clinical Medical College of Three Gorges University
Yichang, China, 443002
Actively Recruiting
Research Team
X
Xinhua Xu, Master
CONTACT
X
Xinhua Xinhua, Master
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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