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Clinical Trials in China / NCT06001151
Recruiting Phase 2

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

NCT06001151 · tracked via the Priya Life Science China tracker
Sponsor
Qian Chu
Phase
Phase 2
Started
2023-08-07
Last updated
2023-08-21

Condition(s) studied

Carcinoma, Non-Small-Cell Lung

Investigational drug(s) / intervention(s)

CadonilimabPemetrexedCarboplatin

Cadonilimab: Patients receive cadonilimab (10mg/kg) every 3 weeks.

Pemetrexed: Patients receive pemetrexed (500mg/m2) every 3 weeks.

Carboplatin: Patients receive carboplatin (AUC=5) every 3 weeks for 4 cycles.

Study 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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Qian Chu Wuhan Hubei Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06001151 on ClinicalTrials.gov ↗ ← All trials in China