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

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• 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.

Egyéb

• Central nervous system metastasis or meningeal metastasis with clinical symptoms.
• Pregnant or lactating women.
• The researcher believes that the subject is not suitable to participate in this clinical study due to other reasons.

• 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.