Loading clinical trials...

Disitamab Vedotin Combined Therapy for Locally Advanced or Metastatic NSCLC Patients With HER2 Alterations | Clinical Trials | Clareo Health

UNKNOWNPHASE2

Disitamab Vedotin Combined Therapy for Locally Advanced or Metastatic NSCLC Patients With HER2 Alterations

Disitamab Vedotin Combined Therapy for Locally Advanced or Metastatic NSCLC With HER2 Alterations, a Phase II Study

NCT05847764•Sun Yat-sen University

View on ClinicalTrials.gov

Summary

Disitamab Vedotin combined therapy locally advanced or metastatic NSCLC Patients with HER2 Alterations.

Detailed Description

This study will explore the treatment of locally advanced or metastatic non-small cell lung cancer with HER2 mutation, amplification, or HER2 mutation (mutation, amplification, protein over-expression) using Disitamab Vedotin（RC48） combined with Tislelizumab or third-generation EGFR-TKI Furmonertinib, in the aim of providing new treatment strategies for lung cancer patients with HER2 pathway activation.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age: 18 (inclusive) or above, regardless of gender.
•2. Histologically or cytologically confirmed locally advanced or metastatic NSCLC, not suitable for radical surgery or radiotherapy (TNM 8th Edition).".
•3. Biomarker:
•* Arm 1: HER2 alterations, no other driver gene mutations；
•* Arm 2: EGFR mutations accompanied by HER2 alterations;
•* Arm 3: HER2 gene mutations, no other driver gene alterations;
•4. Number of treatment lines:
•* Arm 1-2: patients who have not previously received systemic treatment for advanced diseases;
•* Arm3:Failed with at least one line of standard treatment or intolerance;
•5. Patients who have previously undergone neoadjuvant chemotherapy, adjuvant chemotherapy, radiotherapy, or radiochemotherapy for the purpose of curing non metastatic diseases must have a disease-free interval of 6 months from the last chemotherapy and/or radiotherapy to the randomization date.
+3 more criteria

Exclusion Criteria

•1. Central nervous system metastasis or meningeal metastasis with clinical symptoms.
•2. Have a history of autoimmune diseases, immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation.
•3. Active hepatitis B (hepatitis B virus titer\>1000 copies/ml or 200 IU/ml); Hepatitis C virus and syphilis infection.
•4. Have undergone major organ surgery (excluding puncture biopsy) or have experienced significant trauma within 3 weeks before the first use of the study drug.
•5. Known hypersensitivity or intolerance to any component of the study protocol drug or its excipients.

Locations (1)

SunYat-senU

Guanzhou, China

Key Dates

Start Date

May 1, 2023

Primary Completion Date

October 1, 2024

Completion Date

May 1, 2025

Last Updated

May 8, 2023

Enrollment

ESTIMATED participants

Conditions

Non Small Cell Lung CancerERBB2 Mutation-Related TumorsRC48Disitamab Vedotin

Interventions

RC48+Tislelizumab+carboplatin

DRUG

RC48+Furmonertinib, 1L

DRUG

RC48+Furmonertinib, 2L+

DRUG

Contacts

Li PI Zhang, MD

CONTACT

020-87343421 zhangli@sysucc.org.cn

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

NCT06066138

Locally Advanced Alveolar Soft Part SarcomaMetastatic Alveolar Soft Part Sarcoma+8 more

View study

RECRUITING

Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors

NCT07485114

Renal Cell Carcinoma (Kidney Cancer)Non Small Cell Lung Cancer+2 more

View study

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: May 8, 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.

View ClinicalTrials.gov Terms and Conditions

Disitamab Vedotin Combined Therapy for Locally Advanced or Metastatic NSCLC Patients With HER2 Alterations

Inclusion Criteria

Exclusion Criteria

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors

Study of STK-012 Alone and With Other Treatments in Patients With Advanced Lung Cancer and Other Cancers

A Study to Evaluate the Benefit of Adding Durvalumab After Chemotherapy, Durvalumab and Surgery in Patients With Early-stage, Operable, Non-small Cell Lung Cancer.

Reduced CT + Anti-PD-1 as First Line Tx in Vulnerable Older Adults w/Adv <50% PD-L1 Non-Small Cell Lung Cancer (NSCLC)

A Study to Compare Pharmacokinetics, Efficacy, Safety, and Immunogenicity of MB12 (Proposed Pembrolizumab Biosimilar) to Keytruda® in Non-small Cell Lung Cancer (BENITO Study)