Trial Title:
Cadonilimab Plus Chemotherapy as First-line Treatment for PD-L1 Negative NSCLC
NCT ID:
NCT06424821
Condition:
NSCLC
Conditions: Keywords:
PD-L1 negative
PD-1/CTLA-4 bispecific antibody
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Cadonilimab
Description:
Cadonilimab + chemotherapy
Arm group label:
Trial group
Other name:
Cadonilimab group
Summary:
The goal of this clinical trial is to investigate the efficacy, safety and tolerability
of PD-1/CTLA-4 inhibitor (Cadonilimab) combination with chemotherapy as first-line
treatment for PD-L1 negative advanced non small cell lung cancer patients. And also
explore the potential biomarkers for predicting the efficacy of PD-1/CTLA-4 inhibitor for
advanced non small cell lung cancer.
Detailed description:
LungCadX is a multi-center, open-label, single-arm, investigator initiated, phase Ⅱ
study. Patients received cadonilimab (10 mg/kg, IV, every 3 weeks) plus platinum-based
chemotherapy (carboplatin [area under the curve (AUC) 5 mg/mL per min, IV] and paclitaxel
[175 mg/m2, IV] for squamous NSCLC, or carboplatin [AUC 5 mg/mL per min, IV] and
pemetrexed [500 mg/m2, IV] for non-squamous NSCLC) for up to four cycles, followed by
maintenance therapy with cadonilimab for squamous NSCLC, and intravenous cadonilimab plus
pemetrexed for non-squamous NSCLC. The primary endpoint was 12-month PFS rate by
investigator assessment per RECIST 1.1. Secondary endpoints included PFS, OS,
ORR，DoR，DCR, and the safety. Exploratory objective was to assess blood/tumor/urine/faeces
tissue for potential biomarkers study. Adverse events will be monitored throughout the
trial and graded according to the CTCAE v5.0.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Written informed consent must be obtained before implementing any trial-related
procedures;
- Aged 18-80 years;
- Expected survival of more than 3 months;
- The investigator confirms the presence of at least one measurable lesion according
to RECIST 1.1 criteria;
- Wild-type EGFR/ALK;
- Patients with locally advanced (stage IIIb/IIIc), metastatic, or recurrent (stage
IV) NSCLC confirmed by histology or cytology, who are not eligible for curative
surgery and cannot undergo definitive radiotherapy/chemotherapy, according to the
8th edition of the TNM staging classification by the International Association for
the Study of Lung Cancer and the American Joint Committee on Cancer;
- PD-L1 expression in tumor tissue with Tumor Proportion Score (TPS) < 1%;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
- No prior systemic anti-tumor treatment for advanced/metastatic disease; patients who
have previously received platinum-based adjuvant chemotherapy/radiotherapy,
neoadjuvant chemotherapy/radiotherapy, or curative radiotherapy for advanced disease
and experienced disease progression more than 6 months after the last treatment can
participate in this study;
- Adequate hematologic function, defined as absolute neutrophil count (ANC) >= 1.5 x
10^9/L, platelet count >= 100 x 10^9/L, hemoglobin >= 90 g/L (without transfusion
history within 7 days);
- Adequate liver function, defined as total bilirubin level <= 1.5 times the upper
limit of normal (ULN) and aspartate aminotransferase (AST) and alanine
aminotransferase (ALT) levels <= 2.5 times ULN in all patients, or <= 5 times ULN in
patients with liver metastases;
- Adequate renal function, defined as serum creatinine <= 1.5 times ULN;
- Adequate coagulation function, defined as international normalized ratio (INR) or
prothrombin time (PT) <= 1.5 times ULN; for subjects receiving anticoagulant
therapy, INR/PT should be within the range planned by the anticoagulant;
- Women of childbearing potential must have a negative pregnancy test within 7 days
before starting treatment, and must use reliable contraceptive measures (such as
intrauterine device, contraceptive pills, and condoms) during the trial and for 30
days after the end of the trial; male subjects of reproductive potential must use
condoms for contraception during the trial and for 30 days after the end of the
trial;
- Willingness to comply with regular follow-up visits and trial requirements.
Exclusion Criteria:
- Currently participating in interventional clinical research treatment;
- Previously received the following therapies: anti-PD-1, anti-PD-L1, or anti-PD-L2
drugs, or drugs targeting another stimulatory or co-inhibitory T-cell receptor (such
as CTLA-4, OX-40, CD137);
- Received traditional Chinese medicine or immunomodulatory drugs (such as
thymopeptide, interferon, interleukin, etc.) with anti-tumor indications within 2
weeks prior to the first dose;
- Known allergy to the active ingredient or any excipients of Cadonilimab;
- Active hemoptysis, active diverticulitis, intra-abdominal abscess, gastrointestinal
obstruction, or peritoneal metastasis requiring clinical intervention;
- Uncontrolled pleural effusion/ascites clinically (patients who do not require
drainage of effusion or whose effusion does not increase significantly for 3 days
can be included);
- Tumor compression of important organs (such as the esophagus) with accompanying
symptoms, compression of the superior vena cava, or invasion of mediastinal large
blood vessels, heart, etc.;
- History of severe complications such as severe pulmonary or cardiac disease, with
any arterial thrombosis, embolism, or ischemia occurring within 6 months prior to
enrollment, such as myocardial infarction, unstable angina, cerebrovascular
accident, or transient ischemic attack. History of deep vein thrombosis, pulmonary
embolism, or any other serious thrombotic events within 3 months prior to enrollment
(thrombotic events related to implanted venous infusion ports or catheters, or
superficial vein thrombosis are not considered "serious" thrombotic events);
- History of autoimmune diseases, including but not limited to myasthenia gravis,
myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis,
inflammatory bowel disease, vasculitis, or glomerulonephritis related to
antiphospholipid syndrome; Patients with stable hypothyroidism on replacement
therapy with thyroid hormones are eligible to participate in this study; Patients
with controlled type 1 diabetes after receiving a stable insulin treatment regimen
are eligible to participate in this study;
- Received systemic corticosteroids (> 10 mg/day of prednisone or equivalent) or other
systemic immunosuppressive agents (including but not limited to prednisone,
dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and
anti-tumor necrosis factor [anti-TNF] drugs) within 2 weeks prior to randomization;
Use of topical, ocular, intra-articular, intranasal, and inhaled corticosteroids is
allowed;
- Active systemic infections, including tuberculosis (TB) (clinical diagnosis based on
clinical history, physical examination, radiographic findings, and TB testing
according to local medical practices), hepatitis B (known positive for hepatitis B
surface antigen (HBsAg) with HBV DNA >= 1,000 cps/mL or its lower limit of reference
range), hepatitis C, or human immunodeficiency virus (HIV) (positive for HIV
antibody);
- Known presence of mental illness or substance abuse that may affect compliance with
trial requirements;
- History of conditions, diseases, treatments, or laboratory abnormalities that may
interfere with trial results or hinder the subject's full participation in the
study, or as determined by the investigator that participation in the study is not
in the best interest of the subject.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai Chest Hospital
Address:
City:
Shanghai
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Tianqing Chu
Email:
tianqingchu@126.com
Facility:
Name:
NINGBO No.2 Hospital
Address:
City:
Ningbo
Zip:
315016
Country:
China
Status:
Recruiting
Contact:
Last name:
Liangqing Nie
Phone:
15356884370
Start date:
July 4, 2023
Completion date:
September 4, 2025
Lead sponsor:
Agency:
Shanghai Pulmonary Hospital, Shanghai, China
Agency class:
Other
Source:
Shanghai Pulmonary Hospital, Shanghai, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06424821
