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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)

Primary Purpose

Carcinoma, Non-Small-Cell Lung

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Cadonilimab
Pemetrexed
Carboplatin
Sponsored by
Qian Chu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung focused on measuring non-squamous Non-Small Cell Lung Cancer, Programmed Cell Death Ligand 1, cadonilimab

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Qian ChuRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental Arm

Arm Description

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.

Outcomes

Primary Outcome Measures

12-month progression-free-survival (PFS) rate
Rate of patients with complete/partial response at 12-month from enrollment

Secondary Outcome Measures

objective response rate (ORR)
objective response rate using RECIST 1.1 criteria
duration of response (DOR)
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
disease control rate (DCR)
disease control rate using RECIST 1.1 criteria
time to response (TTR)
Time from the date of enrollment to the first documented response (CR or PR) (RECIST 1.1)
progression free survival (PFS)
Time from enrollment to first observation of progression (RECIST1.1) or date of death (from any cause)
overall survival (OS)
Time from enrollment until death due to any cause
incidence, type and severity of adverse events
Descriptive statistics of safety will be presented using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0

Full Information

First Posted
August 12, 2023
Last Updated
August 18, 2023
Sponsor
Qian Chu
Collaborators
Akeso Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT06001151
Brief 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
Acronym
ACHELOUS
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 7, 2023 (Actual)
Primary Completion Date
August 31, 2025 (Anticipated)
Study Completion Date
August 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Qian Chu
Collaborators
Akeso Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Non-Small-Cell Lung
Keywords
non-squamous Non-Small Cell Lung Cancer, Programmed Cell Death Ligand 1, cadonilimab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
49 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Cadonilimab
Other Intervention Name(s)
AK104
Intervention Description
Patients receive cadonilimab (10mg/kg) every 3 weeks.
Intervention Type
Drug
Intervention Name(s)
Pemetrexed
Intervention Description
Patients receive pemetrexed (500mg/m2) every 3 weeks.
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Patients receive carboplatin (AUC=5) every 3 weeks for 4 cycles.
Primary Outcome Measure Information:
Title
12-month progression-free-survival (PFS) rate
Description
Rate of patients with complete/partial response at 12-month from enrollment
Time Frame
At 12 months
Secondary Outcome Measure Information:
Title
objective response rate (ORR)
Description
objective response rate using RECIST 1.1 criteria
Time Frame
about 24 months
Title
duration of response (DOR)
Description
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
Time Frame
about 24 months
Title
disease control rate (DCR)
Description
disease control rate using RECIST 1.1 criteria
Time Frame
about 24 months
Title
time to response (TTR)
Description
Time from the date of enrollment to the first documented response (CR or PR) (RECIST 1.1)
Time Frame
about 24 months
Title
progression free survival (PFS)
Description
Time from enrollment to first observation of progression (RECIST1.1) or date of death (from any cause)
Time Frame
about 24 months
Title
overall survival (OS)
Description
Time from enrollment until death due to any cause
Time Frame
about 24 months
Title
incidence, type and severity of adverse events
Description
Descriptive statistics of safety will be presented using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0
Time Frame
From time of informed consent through treatment period and up to 30 days post last dose of study treatment (about 24 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qian Chu
Phone
13212760751
Ext
+86
Email
qianchu@tjh.tjmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qian Chu
Organizational Affiliation
Tongji Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Qian Chu
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qian Chu
Phone
13212760751
Ext
+86
Email
qianchu@tjh.tjmu.edu.cn

12. IPD Sharing Statement

Learn more about this trial

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

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