The Efficacy and Safety of KN046 Combined With Axitinib

NCT ID: NCT06020352

Last Updated: 2023-08-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-25
• Study Completion Date: 2025-07-01

Brief 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.

Conditions

NSCLC

Keywords

KN046; Axitinib; neoadjuvant

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment group

KN046 combined with axitinib as a neoadjuvant treatment regimen

Group Type: EXPERIMENTAL

KN046 plus Axitinib

Intervention Type: DRUG

KN046 combined with axitinib as a neoadjuvant treatment regimen

Interventions

KN046 plus Axitinib

KN046 combined with axitinib as a neoadjuvant treatment regimen

Intervention Type: DRUG

Other Intervention Names

surgical resection and selective adjuvant therapy with KN046

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Pulmonary Hospital, Shanghai, China

OTHER

Sponsor Role: lead

Responsible Party

Chang Chen

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

l: 2031222@tongji.edu.cn Chen, Dr

Role: STUDY_CHAIR

Shanghai Pulmonary Hospital, Shanghai, China

Locations

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Site Status: RECRUITING

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Chang Chen, Dr

Role: CONTACT

Phone: 65115006

Email: 2031222@tongji.edu.cn

Facility Contacts

Bentong Yu, Dr

Role: primary

Chang Chen, MD, PhD

Role: primary

Other Identifiers

STAR003

Identifier Type: -

Identifier Source: org_study_id