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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

About this trial

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

Eligibility criteria

Qualifiers

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;

Arm1: patients who have not previously received systemic treatment for advanced diseases;

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Disitamab Vedotin
  • third-generation EGFR TKIs (Almonertinib/Furmonertinib/Osimertinib)
  • pyrotinib

Treatment groups

108 Participants
are divided into 3 treatment groups

Locations

This trial has no locations