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drugset / Trial / NCT04447118

Phase 3 Study of Pyrotinib Versus Docetaxel in Patients With Advanced Non-squamous NSCLC Harboring a HER2 Exon 20 Mutation Who Failed Platinum Based Chemotherapy

NCT04447118 ↗

Phase 3 Completed 151 enrolled Jiangsu HengRui Medicine Co., Ltd.
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2020-09-11
Primary completion
2023-06-02
Completion
2024-12-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Docetaxel Small molecule 75 mg/m2 Intravenous
Subject Pyrotinib Small molecule 400 mg Oral

Indications

non-small cell lung carcinoma