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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 (ACHELOUS)

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ClinicalTrials.gov Identifier: NCT06001151
Recruitment Status : Recruiting
First Posted : August 21, 2023
Last Update Posted : August 21, 2023
Sponsor:
Collaborator:
Akeso Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Qian Chu, Tongji Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: Cadonilimab Drug: Pemetrexed Drug: Carboplatin Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 49 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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：A Multi-center, Single-arm, Phase II Study
Actual Study Start Date : August 7, 2023
Estimated Primary Completion Date : August 31, 2025
Estimated Study Completion Date : August 31, 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Drug: Cadonilimab
Patients receive cadonilimab (10mg/kg) every 3 weeks.
Other Name: AK104

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

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


Outcome Measures
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Primary Outcome Measures :
  1. 12-month progression-free-survival (PFS) rate [ Time Frame: At 12 months ]
    Rate of patients with complete/partial response at 12-month from enrollment


Secondary Outcome Measures :
  1. objective response rate (ORR) [ Time Frame: about 24 months ]
    objective response rate using RECIST 1.1 criteria

  2. duration of response (DOR) [ Time Frame: about 24 months ]
    Time from the date of the first documented response (CR or PR) to the earliest date of disease progression (RECIST 1.1), or death due to any cause

  3. disease control rate (DCR) [ Time Frame: about 24 months ]
    disease control rate using RECIST 1.1 criteria

  4. time to response (TTR) [ Time Frame: about 24 months ]
    Time from the date of enrollment to the first documented response (CR or PR) (RECIST 1.1)

  5. progression free survival (PFS) [ Time Frame: about 24 months ]
    Time from enrollment to first observation of progression (RECIST1.1) or date of death (from any cause)

  6. overall survival (OS) [ Time Frame: about 24 months ]
    Time from enrollment until death due to any cause

  7. incidence, type and severity of adverse events [ Time Frame: From time of informed consent through treatment period and up to 30 days post last dose of study treatment (about 24 months) ]
    Descriptive statistics of safety will be presented using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06001151


Contacts
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Contact: Qian Chu 13212760751 ext +86 qianchu@tjh.tjmu.edu.cn

Locations
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China, Hubei
Qian Chu Recruiting
Wuhan, Hubei, China, 430030
Contact: Qian Chu    13212760751 ext +86    qianchu@tjh.tjmu.edu.cn   
Sponsors and Collaborators
Qian Chu
Akeso Pharmaceuticals, Inc.
Investigators
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Principal Investigator: Qian Chu Tongji Hospital
More Information
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Responsible Party: Qian Chu, Professor, Tongji Hospital
ClinicalTrials.gov Identifier: NCT06001151    
Other Study ID Numbers: S019
First Posted: August 21, 2023    Key Record Dates
Last Update Posted: August 21, 2023
Last Verified: August 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Qian Chu, Tongji Hospital:
non-squamous Non-Small Cell Lung Cancer
Programmed Cell Death Ligand 1
cadonilimab
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
 Bronchial Neoplasms
Carboplatin
Pemetrexed
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors