Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05847764
Other study ID # RCVDODIIR006
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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.

Study Design


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)
See also
  Status Clinical Trial Phase
Recruiting NCT05094804 - A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents Phase 1/Phase 2
Recruiting NCT05707286 - Pilot Study to Determine Pro-Inflammatory Cytokine Kinetics During Immune Checkpoint Inhibitor Therapy
Recruiting NCT04258137 - Circulating DNA to Improve Outcome of Oncology PatiEnt. A Randomized Study N/A
Completed NCT01945021 - Phase II Safety and Efficacy Study of Crizotinib in East Asian Patients With ROS1 Positive, ALK Negative Advanced NSCLC Phase 2
Completed NCT04487457 - Prospective Study to Evaluate the Blood Kinetics of Immune Cells and Immunosuppressive Cytokines After Exposure to an Immunity Checkpoint Inhibitor (ICI): Study of the Impact of Chemotherapy
Terminated NCT04022876 - A Study of ALRN-6924 for the Prevention of Chemotherapy-induced Side Effects (Chemoprotection) Phase 1
Recruiting NCT05898763 - TEIPP Immunotherapy in Patients With NSCLC Phase 1/Phase 2
Recruiting NCT05532696 - Phase 1b/2 Study to Evaluate ABT-101 in Solid Tumor and NSCLC Patients Phase 1/Phase 2
Completed NCT04311034 - A Study of RC48-ADC in Subjects With Advanced Non-small Cell Lung Cancer Phase 1/Phase 2
Active, not recruiting NCT03177291 - Pirfenidone Combined With Standard First-Line Chemotherapy in Advanced-Stage Lung NSCLC Phase 1
Terminated NCT03257722 - Pembrolizumab + Idelalisib for Lung Cancer Study Phase 1/Phase 2
Completed NCT00349089 - Trial on Refinement of Early Stage Lung Cancer Adjuvant Therapy Phase 2
Completed NCT05116891 - A Phase 1/2 Study of CAN04 in Combination With Different Chemotherapy Regimens in Subjects With Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT04571632 - Clinical Trial of SBRT and Systemic Pembrolizumab With or Without Avelumab/Ipilimumab+ Dendritic Cells in Solid Tumors Phase 2
Terminated NCT03599518 - DS-1205c With Gefitinib for Metastatic or Unresectable Epidermal Growth Factor Receptor (EGFR)-Mutant Non-Small Cell Lung Cancer Phase 1
Not yet recruiting NCT06020989 - Lazertinib and Chemotherapy Combination in EGFR-mutant NSCLC Patients Without ctDNA Clearance After lead-in Lazertinib Monotherapy Phase 2
Withdrawn NCT03982134 - PDR001 + Panobinostat for Melanoma and NSCLC Phase 1
Withdrawn NCT03574649 - QUILT-2.024: Phase 2 Neoadjuvant, Consolidation, and Adjuvant Combination NANT Immunotherapy Versus Standard of Care in Subjects With Resectable Non-small Cell Lung Cancer Phase 2
Withdrawn NCT02844140 - DE-CT in Lung Cancer Proton Therapy N/A
Terminated NCT02628535 - Safety Study of MGD009 in B7-H3-expressing Tumors Phase 1