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

Non Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05847764
• Other study ID #: RCVDODIIR006
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: May 2023
• Est. completion date: May 2025

Study information

• Verified date: May 2023
• Source: Sun Yat-sen University
• Contact: Li PI Zhang, MD
• Phone: 020-87343421
• Email: zhangli[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 95
• Est. completion date: May 2025
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non Small Cell Lung Cancer

Intervention

Drug:
• RC48+Tislelizumab+carboplatin
RC48+PD-1/PD-L1 inhibitor+chemo in treatment-naive patients harboring HER2 alterations
• RC48+Furmonertinib, 1L
RC48+Furmonertinib in treatment-naive patients harboring EGFR mutations as well as HER2 alterations
• RC48+Furmonertinib, 2L+
RC48+Furmonertinib in patients who failed at least one line of standard treatment and harboring HER2 alterations

Locations

Country	Name	City	State
China	SunYat-senU	Guanzhou

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Disease control rate (DCR) Following Treatment in Participants With HER2 alterations Non-Small-Cell Lung Cancer (NSCLC)	Defined as the proportion of participants who have a complete response (CR), partial response (PR) or standard disease (SD) as assessed by investigator according to RECIST 1.1	Up to 24 months (data cut-off)
Secondary	Progression-free survival (PFS) Following Treatment in Participants With HER2 alterations Non-Small-Cell Lung Cancer (NSCLC)	Defined as time from randomization until progression per RECIST 1.1 as assessed by investigator, or death due to any cause.	Up to 24 months (data cut-off)
Secondary	Duration of Response (DoR) Following Treatment in Participants With HER2 alterations Non-Small-Cell Lung Cancer (NSCLC)	Defined as the time from the date of first documented response until date of documented progression as assessed by investigator assessment according to RECIST 1.1.	Up to 24 months (data cut-off)
Secondary	Overall Survival (OS) Following Treatment in Participants With HER2 alterations Non-Small-Cell Lung Cancer (NSCLC)	Defined as time from randomization until the date of death due to any cause.	Up to 24 months (data cut-off)