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

NCT ID: NCT06001151

Last Updated: 2023-08-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-07
• Study Completion Date: 2027-08-31

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.

Detailed Description

This trial enrolled advanced or metastatic non-squamous Non-Small Cell Lung Cancer (NSCLC) Patients with Programmed Cell Death Ligand 1 (PD-L1) negative. 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. The primary endpoint is 12-month progression-free-survival (PFS) rate assessed by investigators. Key secondary endpoints include objective response rate (ORR), duration of response (DOR), disease control rate (DCR), time to response (TTR), progression free survival (PFS), overall survival (OS), and safety.

Conditions

Carcinoma, Non-Small-Cell Lung

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental Arm

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.

Group Type: EXPERIMENTAL

Cadonilimab

Intervention Type: DRUG

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

Pemetrexed

Intervention Type: DRUG

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

Carboplatin

Intervention Type: DRUG

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

Interventions

Cadonilimab

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

Intervention Type: DRUG

Pemetrexed

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

Intervention Type: DRUG

Carboplatin

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

Intervention Type: DRUG

Other Intervention Names

AK104

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Akeso Pharmaceuticals, Inc.

OTHER

Sponsor Role: collaborator

Qian Chu

OTHER

Sponsor Role: lead

Responsible Party

Qian Chu

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Qian Chu

Role: PRINCIPAL_INVESTIGATOR

Tongji Hospital

Locations

Qian Chu

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Qian Chu

Role: CONTACT

qianchu@tjh.tjmu.edu.cn

13212760751 ext. +86

Facility Contacts

Qian Chu

Role: primary

qianchu@tjh.tjmu.edu.cn

13212760751 ext. +86

Other Identifiers

S019

Identifier Type: -

Identifier Source: org_study_id