Actively Recruiting
Cadonilimab (AK104) Plus Chemotherapy as First-line Treatment in Non-squamous Non-Small Cell Lung Cancer (NSCLC) Patients With Programmed Cell Death Ligand 1 (PD-L1) Negative
Led by Qian Chu · Updated on 2023-08-21
49
Participants Needed
1
Research Sites
212 weeks
Total Duration
On this page
Sponsors
Q
Qian Chu
Lead Sponsor
A
Akeso Pharmaceuticals, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a single arm, multi-center clinical trial. Target population is advanced or metastatic non-squamous Non-Small Cell Lung Cancer (NSCLC) Patients with Programmed Cell Death Ligand 1 (PD-L1) negative, aiming to evaluate the efficacy and safety of the combination therapy of Cadonilimab and chemotherapy. Cadonilimab is a PD-1/CTLA-4 bi-specific antibody.
CONDITIONS
Official Title
Cadonilimab (AK104) Plus Chemotherapy as First-line Treatment in Non-squamous Non-Small Cell Lung Cancer (NSCLC) Patients With Programmed Cell Death Ligand 1 (PD-L1) Negative
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with histologically or cytologically confirmed stage IIIB, IIIC, or IV non-squamous Non-Small Cell Lung Cancer (NSCLC)
- PD-L1 tumor proportion score (TPS) less than 1%
- Life expectancy longer than 3 months
- No EGFR-sensitive mutations (19Exon deletion or 21Exon L858R), ALK, ROS1 gene rearrangements or fusions
- No prior systemic therapy; chemotherapy or radiotherapy allowed as neoadjuvant/adjuvant if recurrence or metastasis occurred more than 6 months after treatment
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- At least one measurable lesion according to RECIST 1.1 criteria
- Adequate organ function
- Agree to provide tumor tissue samples for biomarker research including PD-L1 testing
- Voluntarily sign written informed consent
You will not qualify if you...
- Small Cell Lung Cancer or squamous Non-Small Cell Lung Cancer diagnosed by histology
- Active central nervous system metastases confirmed by CT or MRI
- Other malignancies within 3 years before enrollment
- Severe infections within 4 weeks before first treatment dose
- Women who are pregnant or breastfeeding
- History of interstitial lung disease, drug-induced interstitial lung disease, or radiation pneumonitis needing hormone therapy
- History of myocarditis, cardiomyopathy, or dangerous heart arrhythmias
- Tumors compressing vital organs causing symptoms or invading major vessels or heart
- Risk of bleeding, major hemoptysis, or history of clotting disorders
- Active autoimmune diseases needing systemic treatment within 2 years before enrollment
- History of HIV infection
- Active hepatitis B infection
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Qian Chu
Wuhan, Hubei, China, 430030
Actively Recruiting
Research Team
Q
Qian Chu
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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