The Efficacy and Safety of KN046 Combined With Axitinib

NCT06020352 | Unknown Phase 2

• 1 other identifier: STAR003
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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

Conditions

NSCLC

Keywords

KN046; Axitinib; neoadjuvant

Outcome Measures

Primary Outcomes (2)

• MPR

  MPR is defined as the presence of ≤ 10% of active tumor cells in postoperative pathology (primary lesion).

  one month within postsurgery

• Surgical resection rate

  Surgical resection rate: refers to the proportion of subjects who completed the surgery according to the plan, defined as the distance from the last neoadjuvant treatment administration, and the surgical time ≤ 6 weeks.

  six weeks after last cycle of neoadjuvant therapy

Secondary Outcomes (3)

• Complication rate

  three months within postsurgery

• pCR

  one month within postsurgery

• ORR

  one month within postsurgery

Study Arms (1)

Treatment group

EXPERIMENTAL

KN046 combined with axitinib as a neoadjuvant treatment regimen

Drug: KN046 plus Axitinib

Interventions

KN046 plus Axitinib DRUG

KN046 combined with axitinib as a neoadjuvant treatment regimen

Also known as: surgical resection and selective adjuvant therapy with KN046

Treatment group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Confirmed by histology or cytology as non-small cell lung cancer;
• NSCLC patients evaluated by researchers as resectable in stage IB-IIIB (stage IIIB only limited to T3N2M0) (AJCC 8th edition);
• Has not received any anti-tumor treatment in the past, including but not limited to systemic chemotherapy, immunotherapy, or radiotherapy;
• No allergenic EGFR mutation or ALK change;
• The ECOG score is 0-1 points.

You may not qualify if:

• 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;
• Previously or currently suffering from interstitial pneumonia/lung disease that requires systemic hormone therapy;
• Previous history of allogeneic bone marrow or organ transplantation;
• 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;
• Prior to allocation, they have received systemic anti-cancer treatment, including research drugs targeting current malignant tumors;
• 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;
• Pregnant and/or lactating women.

Sponsors & Collaborators

• Shanghai Pulmonary Hospital, Shanghai, China: lead

Study Sites (2)

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

RECRUITING

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

MeSH Terms

Interventions

Axitinib

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• l: 2031222@tongji.edu.cn Chen, Dr

  Shanghai Pulmonary Hospital, Shanghai, China

  STUDY CHAIR

Central Study Contacts

Chang Chen, Dr

CONTACT

65115006; 2031222@tongji.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 23, 2023
• First Posted: August 31, 2023
• Study Start: August 25, 2023
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: August 31, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)