RC48 Combined With EGFR or HER2 TKI for Locally Advanced or Metastatic NSCLC Patients With HER2 Alterations

Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study ID
NCT06185400
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

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

Interventions

  • Disitamab Vedotin — DRUG
    RC48+third-generation EGFR TKIs (Almonertinib/Furmonertinib/Osimertinib) in treatment naive NSCLC
  • third-generation EGFR TKIs (Almonertinib/Furmonertinib/Osimertinib) — DRUG
    RC48+third-generation EGFR TKIs (Almonertinib/Furmonertinib/Osimertinib) after EGFR-TKIs progression
  • pyrotinib — DRUG
    RC48+pyrotinib after EGFR-TKIs progression

Study Details

Disitamab Vedotin（RC48）combined with EGFR or HER2 TKIs in locally advanced or metastatic NSCLC Patients with HER2 Alterations.

Key Dates

Start date
Feb 1, 2024
Status verified
Dec 2023
Primary completion
Jul 1, 2025
Completion
Dec 1, 2026

Study Design

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

Arms

  • Experimental: Arm1: Treatment Naive NSCLC
    RC48+third-generation EGFR TKIs in treatment-naive patients harboring EGFR mutation and HER2 alterations
  • Experimental: Arm2: Locally Progressed
    This cohort includes ERBB2 altered patients after third-generation EGFR-TKIs treatment with locally or slowly progressed disease, who may continue to benefit from third-generation EGFR-TKIs treatment under investigators' evaluation.
  • Experimental: Arm3: Extensively Progressed
    This cohort includes ERBB2 altered patients after third-generation EGFR-TKIs treatment with extensively progressed disease, who may be less likely to benefit from third-generation EGFR-TKIs treatment under investigators' evaluation.

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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