The Efficacy and Safety of KN046 Combined With Axitinib

Study on the Efficacy and Safety of KN046 Combined With Acitinib as a Neoadjuvant Therapy in Resectable Stage IB-IIIB Non-small Cell Lung Cancer (NSCLC) Patients

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

Study Overview

• Status: Recruiting
• Conditions: NSCLC
• Intervention / Treatment: Drug: KN046 plus Axitinib

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Chang Chen, Dr; Phone Number: 021 65115006; Email: 2031222@tongji.edu.cn

Study Locations

• China
  • Jiangxi
    • Nanchang, Jiangxi, China
      • Recruiting
      • The First Affiliated Hospital of Nanchang University
      • Contact: Bentong Yu, Dr; Phone Number: 021-65115006; Email: 1151697503@qq.com
  • Shanghai
    • Shanghai, Shanghai, China, 200433
      • Recruiting
      • Shanghai Pulmonary Hospital
      • Contact: Chang Chen, MD, PhD; Phone Number: 2074 +86-021-65115006; Email: chenthoracic@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group; KN046 combined with axitinib as a neoadjuvant treatment regimen	Drug: KN046 plus Axitinib; KN046 combined with axitinib as a neoadjuvant treatment regimen; Other Names: surgical resection and selective adjuvant therapy with KN046

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complication rate	The incidence and severity of AE (classified according to CTCAE v5.0), severity, and their relationship with experimental treatment; Any abnormal results of laboratory tests, vital signs, and physical examinations;	three months within postsurgery
pCR	PCR is defined as postoperative pathology (primary lesion) showing the absence of viable tumor cells	one month within postsurgery
ORR	Defined as the proportion of subjects who achieved complete remission (CR) or partial remission (PR) according to RECIST 1.1	one month within postsurgery

Collaborators and Investigators

• Sponsor: Shanghai Pulmonary Hospital, Shanghai, China
• Investigators: Study Chair: l: 2031222@tongji.edu.cn Chen, Dr, Shanghai Pulmonary Hospital, Shanghai, China

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2023
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: August 23, 2023
• First Submitted That Met QC Criteria: August 27, 2023
• First Posted (Estimated): August 31, 2023

Study Record Updates

• Last Update Posted (Estimated): August 31, 2023
• Last Update Submitted That Met QC Criteria: August 27, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: neoadjuvant; Axitinib; KN046
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Axitinib
• Other Study ID Numbers: STAR003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No