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

NCT05847764 | Unknown Phase 2

• 1 other identifier: RCVDODIIR006
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Objective Response Rate (ORR) Based on Investigator Assessment Following Treatment in Participants With HER2 alterations Non-Small-Cell Lung Cancer (NSCLC)

  Percentage of Participants who have a complete response (CR) or partial response (PR) as assessed by investigator according to RECIST 1.1

  Up to 24 months (data cut-off)

Secondary Outcomes (4)

• Disease control rate (DCR) Following Treatment in Participants With HER2 alterations Non-Small-Cell Lung Cancer (NSCLC)

  Up to 24 months (data cut-off)

• Progression-free survival (PFS) Following Treatment in Participants With HER2 alterations Non-Small-Cell Lung Cancer (NSCLC)

  Up to 24 months (data cut-off)

• Duration of Response (DoR) Following Treatment in Participants With HER2 alterations Non-Small-Cell Lung Cancer (NSCLC)

  Up to 24 months (data cut-off)

• Overall Survival (OS) Following Treatment in Participants With HER2 alterations Non-Small-Cell Lung Cancer (NSCLC)

  Up to 24 months (data cut-off)

Study Arms (3)

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

EXPERIMENTAL

Drug: RC48+Tislelizumab+carboplatin

Arm 2: RC48+Furmonertinib, 1L

EXPERIMENTAL

Drug: RC48+Furmonertinib, 1L

Arm 3: RC48+Furmonertinib, 2L+

EXPERIMENTAL

Drug: RC48+Furmonertinib, 2L+

Interventions

RC48+Tislelizumab+carboplatin DRUG

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

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

RC48+Furmonertinib, 1L DRUG

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

Arm 2: RC48+Furmonertinib, 1L

RC48+Furmonertinib, 2L+ DRUG

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

Arm 3: RC48+Furmonertinib, 2L+

Eligibility Criteria

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

You may qualify if:

• Age: 18 (inclusive) or above, regardless of gender.
• Histologically or cytologically confirmed locally advanced or metastatic NSCLC, not suitable for radical surgery or radiotherapy (TNM 8th Edition).".
• 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;
• 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;
• 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.
• There is at least one measurable lesion that meets the definition of the RECIST 1.1 standard at baseline.
• ECOG fitness status score: 0 or 1 point.
• Estimated survival time ≥ 3 months.

You may not qualify if:

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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

SunYat-senU

Guanzhou, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Li PI Zhang, MD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li PI Zhang, MD

CONTACT

020-87343421; zhangli@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Oncology Department

Study Record Dates

• First Submitted: March 21, 2023
• First Posted: May 8, 2023
• Study Start: May 1, 2023
• Primary Completion: October 1, 2024
• Study Completion: May 1, 2025
• Last Updated: May 8, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)