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Trial Title:
The Efficacy and Safety of KN046 Combined With Axitinib
NCT ID:
NCT06020352
Condition:
NSCLC
Conditions: Official terms:
Axitinib
Conditions: Keywords:
KN046
Axitinib
neoadjuvant
Study type:
Interventional
Study phase:
Phase 2/Phase 3
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:
KN046 plus Axitinib
Description:
KN046 combined with axitinib as a neoadjuvant treatment regimen
Arm group label:
Treatment group
Other name:
surgical resection and selective adjuvant therapy with KN046
Summary:
Evaluation of the efficacy of KN046 combined with acitinib as a neoadjuvant therapy for
resectable NSCLC through primary pathological response rate and surgical resection rate
Detailed description:
The purpose of this study is to evaluate the rate of major pathological remission (MPR)
with preoperative use of KN046 versus axitinib, and thus to assess the efficacy of KN046
in combination with axitinib in patients with Stage IB-IIIB (Stage IIIB only T3N2M0)
NSCLC (according to the 8th edition of the AJCC classification) who are scheduled to
undergo surgery. Eligible subjects for this study were candidates for surgery for
resectable stage IB-IIIB (stage IIIB only T3N2M0) NSCLC as judged by the investigator,
with no evidence of distant metastases as assessed, and no evidence of unresectable local
regional tumour extension.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. The subject is at least 18 years old and<75 years old on the day of signing the
informed consent form, regardless of gender, and is willing to follow the research
procedure;
2. Confirmed by histology or cytology as non-small cell lung cancer;
3. NSCLC patients evaluated by researchers as resectable in stage IB-IIIB (stage IIIB
only limited to T3N2M0) (AJCC 8th edition);
4. Has not received any anti-tumor treatment in the past, including but not limited to
systemic chemotherapy, immunotherapy, or radiotherapy;
5. No allergenic EGFR mutation or ALK change;
6. The ECOG score is 0-1 points.
Exclusion Criteria:
1. The lesion of squamous non-small cell lung cancer presents as a central type of lung
cancer accompanied by cavity formation or invasion of blood vessels, with a high
risk of hemoptysis;
2. Previously or currently suffering from interstitial pneumonia/lung disease that
requires systemic hormone therapy;
3. Previous history of allogeneic bone marrow or organ transplantation;
4. Subjects who have undergone major surgical treatment (such as abdominal or thoracic
surgery; excluding diagnostic puncture or peripheral vascular pathway replacement
surgery) or have not recovered from surgical treatment within 28 days before the
administration of this trial;
5. Prior to allocation, they have received systemic anti-cancer treatment, including
research drugs targeting current malignant tumors;
6. Other known malignant tumors are progressing or require active treatment within the
past 5 years. Note: Participants with basal cell carcinoma of the skin, squamous
cell carcinoma of the skin, or carcinoma in situ (excluding bladder carcinoma in
situ) who have received possible radical treatment are not excluded;
7. Pregnant and/or lactating women.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital of Nanchang University
Address:
City:
Nanchang
Country:
China
Status:
Recruiting
Contact:
Last name:
Bentong Yu, Dr
Phone:
021-65115006
Email:
1151697503@qq.com
Facility:
Name:
Shanghai Pulmonary Hospital
Address:
City:
Shanghai
Zip:
200433
Country:
China
Status:
Recruiting
Contact:
Last name:
Chang Chen, MD, PhD
Phone:
+86-021-65115006
Phone ext:
2074
Email:
chenthoracic@163.com
Start date:
August 25, 2023
Completion date:
July 1, 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/NCT06020352
