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
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：A Multi-center, Single-arm, Phase II Study
Qian Chu
49 participants
Aug 7, 2023
INTERVENTIONAL
Conditions
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) 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.
Eligibility
Inclusion Criteria10
- 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 Criteria13
- 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
Interventions
Patients receive cadonilimab (10mg/kg) every 3 weeks.
Patients receive pemetrexed (500mg/m2) every 3 weeks.
Patients receive carboplatin (AUC=5) every 3 weeks for 4 cycles.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06001151