Menu
Not yet recruiting NCT06185400

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

Phase II Interventional Non Small Cell Lung Cancer ERBB2 Mutation-Related Tumors ERBB2 Gene Duplication Disitamab Vedotin

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Disitamab Vedotin, third-generation EGFR TKIs (Almonertinib/Furmonertinib/Osimertinib), pyrotinib.
Who it may be relevant to
Registry conditions: Non Small Cell Lung Cancer, ERBB2 Mutation-Related Tumors, ERBB2 Gene Duplication, Disitamab Vedotin. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Disitamab Vedotin（RC48）Combined With EGFR or HER2 TKI for Locally Advanced or Metastatic NSCLC Patients With HER2 Alterations

Overview

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

Detailed description

This study will explore the treatment of locally advanced or metastatic non-small cell lung cancer with HER2 mutation, amplification, or HER2 protein overexpression, using Disitamab Vedotin（RC48）combined with EGFR or HER2 TKIs, in the aim of providing new treatment strategies for lung cancer patients with HER2 pathway activation.

Interventions

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

Primary outcome measures

  • 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)]
Secondary outcome measures (4)
  • Disease control rate (DCR) Following Treatment in Participants With HER2 alterations Non-Small-Cell Lung Cancer (NSCLC) [Time frame: Up to 24 months (data cut-off)]
  • Progression-free survival (PFS) Following Treatment in Participants With HER2 alterations Non-Small-Cell Lung Cancer (NSCLC) [Time frame: Up to 24 months (data cut-off)]
  • Duration of Response (DoR) Following Treatment in Participants With HER2 alterations Non-Small-Cell Lung Cancer (NSCLC) [Time frame: Up to 24 months (data cut-off)]
  • Overall Survival (OS) Following Treatment in Participants With HER2 alterations Non-Small-Cell Lung Cancer (NSCLC) [Time frame: Up to 24 months (data cut-off)]

Eligibility criteria

Inclusion criteria

  • 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).".
  • HER2 alterations include HER2 gene mutations, gene amplification and HER2 protein over-expression;
  • Number of treatment lines:
  • Arm1: patients who have not previously received systemic treatment for advanced diseases;
  • Arm2: Previously received first line of third-generation EGFR-TKIs treatment with local progression, oligometastasis, or slow progression, and evaluated by the researchers to continue to benefit from third-generation EGFR-TKIs treatment;
  • Arm3: Previously received first line of third-generation EGFR-TKIs treatment with extensively progression, and evaluated by the researchers not likely to continue to benefit from third-generation EGFR-TKIs treatment;
  • 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.

Exclusion criteria

  • Central nervous system metastasis or meningeal metastasis with clinical symptoms.
  • Known hypersensitivity or intolerance to any component of the study protocol drug or its excipients.
  • Have a history of severe cardiovascular disease.
  • Have a history of interstitial lung disease or drug-induced interstitial lung disease requiring steroids treatment; radiation pneumonia.
  • Have a history of neurological disorders or mental illnesses, including epilepsy or dementia.
  • Pregnant or lactating women.
  • The researcher believes that the subject is not suitable to participate in this clinical study due to other reasons.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06185400 · RCVDODIIR010

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗