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Trial Summary

This is a randomized, positive-controlled, open-label, international multicenter, Phase 3 clinical study to compare the efficacy and safety of pyrotinib versus docetaxel in patients with advanced non-squamous NSCLC harboring a HER2 exon 20 mutation who failed platinum based chemotherapy.



ACTRN/NCT /ethics:


Scientific 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.

Sponsor / Cooperative group:

Jiangsu HengRui Medicine Co., Ltd.

Trial & Patient Characteristics

Cancer TypeLung & mesothelioma
Trial TypeTreatment
PhasePhase III
Age Range18 years and older
Tumour Stream Urothelial
Cancer StageLocally Recurrent or Locally Advanced; Metastatic or Widespread
Anticipated Start Date2020-09-11
Anticipated End Date2023-10-31

Participating Hospitals

HospitalCalvary Central Districts Hospital
Clinical Trial CoordinatorJulie Rowe
Phone08 8239 9536
Principal InvestigatorDr Rohit Joshi
Recruitment StatusRecruiting