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Trial Title:
Cadonilimab Monotherapy as Neoadjuvant Therapy for Resectable II-IIIA Squamous Cell Lung Cancer
NCT ID:
NCT05784974
Condition:
Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet 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:
15 mg/kg via intravenous infusion on Day 1 of each 21-day cycle.
Arm group label:
Cadonilimab
Summary:
Cadonilimab, a tetravalent bispecific antibody targeting PD-1 and CTLA-4, is designed to
retain the efficacy benefit of combination of PD-1 and CTLA-4 and improve on the safety
profile of the combination therapy. The aim of this study is to evaluate the efficacy and
safety of Cadonilimab monotherapy as neoadjuvant therapy for patients with resectable
stage II-IIIA squamous cell lung cancer.
Criteria for eligibility:
Criteria:
Key Inclusion Criteria:
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 2. Have previously
untreated and pathologically confirmed resectable Stage II-IIIA Squamous cell lung
cancer.
Have at least one measurable lesion per RECIST 1.1 assessed by investigator. Have
adequate organ function.
Key Exclusion Criteria:
Mixed adenocarcinoma and small cell lung cancer histology. Patients with other active
malignancies within 5 years prior to enrollment. Known active autoimmune diseases. Use of
immunosuppressive agents within 14 days prior to the first dose of study treatment.
Presence of other uncontrolled serious medical conditions.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
May 1, 2023
Completion date:
May 1, 2028
Lead sponsor:
Agency:
The First Hospital of Jilin University
Agency class:
Other
Source:
The First Hospital of Jilin University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05784974
