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

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 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

Conditions3

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