WHO ICTRP trial

A Clinical study of Trastuzumab Deruxtecan as first line Treatment for Non-Small…

CTRI/2022/02/040116 · Clinical Trials Registry India (CTRI) · Not Recruiting

Key facts

Trial ID CTRI/2022/02/040116
Public title A Clinical study of Trastuzumab Deruxtecan as first line Treatment for Non-Small Cell Lung Cancer
Scientific title An Open-label, Randomized, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Trastuzumab Deruxtecan as First-line Treatment of Unresectable, Locally Advanced, or Metastatic NSCLC Harboring HER2 Exon 19 or 20 Mutations (DESTINY-Lung04)
Primary sponsor AstraZeneca AB
Secondary sponsors AstraZeneca Pharma India Limited
Registry Clinical Trials Registry India (CTRI)
Recruitment status Not Recruiting
Study type Interventional
Phase Phase 3
Countries Australia;Brazil;Bulgaria;Canada;China;Denmark;France;Germany;Hong Kong;India;Italy;Japan;Mexico;Netherlands;Poland;Republic of Korea;Spain;Sweden;Taiwan;Turkey;United States of America
Conditions Health Condition 1: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung
Interventions Intervention1: Trastuzumab Deruxtecan (T-DXd): Trastuzumab Deruxtecan ((T-DXd) monotherapy by IV administration Q3W until RECIST 1.1 defined progression by investigator Control Intervention1: Cisplatin or carboplatin with pemetrexed and…
Registration date Aug 2, 2022
Target size 264
Secondary IDs 2021-000634-33;D967SC00001 VERSION 1.0, Dated 08 JUL 2021;NCT05048797
Registry page ctri.nic.in

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