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

NCT ID: NCT05847764

Last Updated: 2023-05-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 95 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-31
• Study Completion Date: 2025-05-31

Brief 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.

Conditions

Non Small Cell Lung Cancer; ERBB2 Mutation-Related Tumors; RC48; Disitamab Vedotin

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1: RC48+PD-1/PD-L1 inhibitor

Group Type: EXPERIMENTAL

RC48+Tislelizumab+carboplatin

Intervention Type: DRUG

RC48+PD-1/PD-L1 inhibitor+chemo in treatment-naive patients harboring HER2 alterations

Arm 2: RC48+Furmonertinib, 1L

Group Type: EXPERIMENTAL

RC48+Furmonertinib, 1L

Intervention Type: DRUG

RC48+Furmonertinib in treatment-naive patients harboring EGFR mutations as well as HER2 alterations

Arm 3: RC48+Furmonertinib, 2L+

Group Type: EXPERIMENTAL

RC48+Furmonertinib, 2L+

Intervention Type: DRUG

RC48+Furmonertinib in patients who failed at least one line of standard treatment and harboring HER2 alterations

Interventions

RC48+Tislelizumab+carboplatin

RC48+PD-1/PD-L1 inhibitor+chemo in treatment-naive patients harboring HER2 alterations

Intervention Type: DRUG

RC48+Furmonertinib, 1L

RC48+Furmonertinib in treatment-naive patients harboring EGFR mutations as well as HER2 alterations

Intervention Type: DRUG

RC48+Furmonertinib, 2L+

RC48+Furmonertinib in patients who failed at least one line of standard treatment and harboring HER2 alterations

Intervention Type: DRUG

Eligibility Criteria

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.

6. There is at least one measurable lesion that meets the definition of the RECIST 1.1 standard at baseline.

7. ECOG fitness status score: 0 or 1 point.

8. Estimated survival time ≥ 3 months.

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.

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

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Li Zhang, MD

Head of Oncology Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Li PI Zhang, MD

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

SunYat-senU

Guanzhou, , China

Countries

China

Central Contacts

Li PI Zhang, MD

Role: CONTACT

zhangli@sysucc.org.cn

020-87343421

Facility Contacts

Li Zhang, MD

Role: primary

Other Identifiers

RCVDODIIR006

Identifier Type: -

Identifier Source: org_study_id