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

Recruiting now · Phase 2

Conditions studied: Carcinoma, Non-Small-Cell Lung

In brief

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.

Key facts

Study ID

NCT06001151

Run by

Qian Chu

People needed

49

Starts

2023-08-07

Expected to finish

2027-08-31

Last updated by the study team

2023-08-21

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Qian Chu — Wuhan, Hubei, China (enrolling)

Full record on ClinicalTrials.gov

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