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UNKNOWNPHASE2/PHASE3

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

NCT06020352•Shanghai Pulmonary Hospital, Shanghai, China

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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.

Locations (2)

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

August 25, 2023

Primary Completion Date

July 1, 2025

Completion Date

July 1, 2025

Last Updated

August 31, 2023

Enrollment

ESTIMATED participants

Conditions

NSCLC

Interventions

KN046 plus Axitinib

DRUG

Contacts

Chang Chen, Dr

CONTACT

65115006 2031222@tongji.edu.cn

Magnetic Resonance Imaging of the Lung: Oncological Applications

NCT07486219

Lung Cancer (NSCLC)

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RECRUITINGPHASE3

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

NCT06305754

Non-small Cell Lung Cancer (NSCLC)

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RECRUITINGPHASE1/PHASE2

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 31, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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The Efficacy and Safety of KN046 Combined With Axitinib

Inclusion Criteria

Exclusion Criteria

Magnetic Resonance Imaging of the Lung: Oncological Applications

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

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