A Phase III Study Comparing Pyrotinib with Docetaxel in Patients with Persistent Non-Squamous Non-Small Cell Lung Cancer with a HER2 Mutation

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Full Title

A Phase 3, Randomized, Open-label, Multicenter Study of the Efficacy and Safety of Pyrotinib versus Docetaxel in Patients with Advanced Non-squamous Non-small Cell Lung Cancer (NSCLC) Harboring a HER2 Exon 20 Mutation who Progressed on or after Treatment with Platinum Based Chemotherapy

Purpose

The purpose of this study is to compare the effectiveness of pyrotinib versus docetaxel in patients with advanced non-squamous non-small cell lung cancer (NSCLC) that has continued to grow despite prior platinum-based chemotherapy and contains a HER2 exon 20 genetic mutation. Pyrotinib is designed to inhibit cancer growth by targeting this mutation.

Patients will be randomly assigned to receive either pyrotinib or docetaxel. Pyrotinib is taken orally (by mouth) and docetaxel is given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have advanced non-squamous NSCLC that has continued to grow despite no more than two prior regimens of therapy that included a platinum-containing drug (such as cisplatin or carboplatin).
  • Patients’ tumors must contain a mutation in exon 20 of the HER2 gene.
  • Patients should recover from the serious side effects of prior therapies.
  • Previous treatment with docetaxel or HER2-targeting medications is not permitted.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Bob Li at 646-608-3791.

Protocol

21-015

Phase

III

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators