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Brief Title: Phase 2 Study of Dacomitinib in NSCLC
Official Title: A Single-arm, Open-label, Phase 2 Study of Dacomitinib With or Without Dose Titration for the First-line Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer in Subjects With an Epidermal Growth Factor Receptor (EGFR) Activation Mutation
Study ID: NCT04027647
Brief Summary: This is a multi-national, multi-centre, single-arm, open-label, Phase 2 clinical study of the efficacy and safety of first-line treatment with dacomitinib, with or without dose titration, in subjects with newly diagnosed stage IIIB/IIIC/IV or recurrent EGFR-mutation-positive non-small cell lung cancer (NSCLC). National Cancer Centre Singapore is the lead sponsor acting in a coordinating capacity and the rest of the participating sites are sponsors of their own individual sites.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Prince of Wales Hospital, Hong Kong, , Hong Kong
Dong-A University Hospital, Busan, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Sarawak General Hospital, Kuching, Sarawak, Malaysia
University Malaya Medical Centre, Kuala Lumpur, , Malaysia
Beacon Hospital, Petaling Jaya, , Malaysia
National Cancer Centre Singapore, Singapore, , Singapore
Phramongkutklao Hospital, Bangkok, , Thailand
Ramathibodi Hospital, Bangkok, , Thailand
Name: Daniel Tan, BSc, MBBS, PhD
Affiliation: National Cancer Centre Singapore (Lead Sponsor)
Role: PRINCIPAL_INVESTIGATOR