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

Sponsor
Sun Yat-sen University
Study ID
NCT05847764
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

Start date
May 31, 2023
Status verified
May 2023
Primary completion
Oct 31, 2024
Completion
May 31, 2025

Study Design

Enrollment
95 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: RC48+PD-1/PD-L1 inhibitor
  • Experimental: Arm 2: RC48+Furmonertinib, 1L
  • Experimental: Arm 3: RC48+Furmonertinib, 2L+

Primary Outcome Measure

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) [ Time Frame: Up to 24 months (data cut-off) ]

Central Contacts

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