Carcinoma, Non-Small-Cell Lung Clinical Trial
— ACHELOUSOfficial 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) Negativeļ¼A Multi-center, Single-arm, Phase II Study
Verified date | August 2023 |
Source | Tongji Hospital |
Contact | Qian Chu |
Phone | 13212760751 |
qianchu[@]tjh.tjmu.edu.cn | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 49 |
Est. completion date | August 31, 2027 |
Est. primary completion date | August 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
China | Qian Chu | Wuhan | Hubei |
Lead Sponsor | Collaborator |
---|---|
Qian Chu | Akeso Pharmaceuticals, Inc. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 12-month progression-free-survival (PFS) rate | Rate of patients with complete/partial response at 12-month from enrollment | At 12 months | |
Secondary | objective response rate (ORR) | objective response rate using RECIST 1.1 criteria | about 24 months | |
Secondary | duration of response (DOR) | Time from the date of the first documented response (CR or PR) to the earliest date of disease progression (RECIST 1.1), or death due to any cause | about 24 months | |
Secondary | disease control rate (DCR) | disease control rate using RECIST 1.1 criteria | about 24 months | |
Secondary | time to response (TTR) | Time from the date of enrollment to the first documented response (CR or PR) (RECIST 1.1) | about 24 months | |
Secondary | progression free survival (PFS) | Time from enrollment to first observation of progression (RECIST1.1) or date of death (from any cause) | about 24 months | |
Secondary | overall survival (OS) | Time from enrollment until death due to any cause | about 24 months | |
Secondary | incidence, type and severity of adverse events | Descriptive statistics of safety will be presented using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0 | From time of informed consent through treatment period and up to 30 days post last dose of study treatment (about 24 months) |
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