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 | Recruiting Phase 2

• 1 other identifier: S019
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

non-squamous Non-Small Cell Lung Cancer; Programmed Cell Death Ligand 1; cadonilimab

Outcome Measures

Primary Outcomes (1)

• 12-month progression-free-survival (PFS) rate

  Rate of patients with complete/partial response at 12-month from enrollment

  At 12 months

Secondary Outcomes (7)

• objective response rate (ORR)

  about 24 months

• duration of response (DOR)

  about 24 months

• disease control rate (DCR)

  about 24 months

• time to response (TTR)

  about 24 months

• progression free survival (PFS)

  about 24 months

Study Arms (1)

Experimental Arm

EXPERIMENTAL

Patients will receive cadonilimab (10mg/kg) plus pemetrexed(500mg/m2) and carboplatin (AUC=5) every 3 weeks for 4 cycles, follwed with cadonilimab (10mg/kg) plus pemetrexed (500mg/m2) every 3 weeks as maintenance therapy.

Drug: Cadonilimab; Drug: Pemetrexed; Drug: Carboplatin

Interventions

Cadonilimab DRUG

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

Also known as: AK104

Experimental Arm

Pemetrexed DRUG

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

Experimental Arm

Carboplatin DRUG

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

Experimental Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Qian Chu: lead
• Akeso Pharmaceuticals, Inc.: collaborator

Study Sites (1)

Qian Chu

Wuhan, Hubei, 430030, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Pemetrexed; Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Coordination Complexes; Organic Chemicals

Study Officials

• Qian Chu

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qian Chu

CONTACT

13212760751; qianchu@tjh.tjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 12, 2023
• First Posted: August 21, 2023
• Study Start: August 7, 2023
• Primary Completion: August 31, 2025
• Study Completion (Estimated): August 31, 2027
• Last Updated: August 21, 2023

Record last verified: 2023-08

Locations

CN (1)