Status:
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
Lead Sponsor:
Qian Chu
Collaborating Sponsors:
Akeso Pharmaceuticals, Inc.
Conditions:
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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) nega...
Detailed Description
This trial enrolled advanced or metastatic non-squamous Non-Small Cell Lung Cancer (NSCLC) Patients with Programmed Cell Death Ligand 1 (PD-L1) negative. Patients will receive cadonilimab (10mg/kg) pl...
Eligibility Criteria
Inclusion
- Patients with histologically/cytologically stage IIIB, IIIC, IV non-squamous Non-Small Cell Lung Cancer (NSCLC)
- PD-L1 TPS\<1%
- Life expectancy more than 3 months
- Without EGFR-sensitive mutation (19Exon del/21Exon L858R), ALK, ROS1 gene rearrangement or fusion
- Has no prior systemic therapy; (chemotherapy and/or radiotherapy is allowed as part of neoadjuvant/adjuvant therapy. Patients who have had recurrence or metastasis for more than 6 months from the end of neoadjuvant/adjuvant treatment would be enrolled)
- ECOG score 0-1
- Patients must have at least one measurable lesion according to RECIST 1.1
- Has adequate organ function
- Agree to provide tumour tissue samples for biomarker exploration (including but not limited to PD-L1 IHC or NGS testing)
- Voluntarily sign a written informed consent form
Exclusion
- Histological examination with Small Cell Lung Cancer or squamous Non-Small Cell Lung Cancer
- With active central nervous system (CNS) metastases confirmed by CT or MRI
- With other malignancy within 3 years before enrollment
- With severe infections within 4 weeks of the first dose of study treatment
- Women who are pregnant or lactating
- History of interstitial lung disease, drug-induced interstitial lung disease, or radiation pneumonia requiring hormone therapy
- History of myocarditis, cardiomyopathy, and malignant arrhythmia
- Tumor compresses important surrounding organs (such as the esophagus) with accompanying symptoms, compressing the superior vena cava or invading the mediastinal vessels, heart, etc.
- Risk of bleeding, major hemoptysis, or with history of coagulation dysfunction
- Active autoimmune diseases that require systematic treatment within 2 years before enrollment
- History of Human Immunodeficiency Virus (HIV)
- With active hepatitis B infection
- With uncontrollable pleural effusion, pericardial effusion, or ascites that require repeated drainage
Key Trial Info
Start Date :
August 7 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2027
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT06001151
Start Date
August 7 2023
End Date
August 31 2027
Last Update
August 21 2023
Active Locations (1)
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1
Qian Chu
Wuhan, Hubei, China, 430030