Status:
COMPLETED
D-0316 First Time in Patients Ascending Dose Study
Lead Sponsor:
InventisBio Co., Ltd
Conditions:
Advanced Non Small Cell Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
This is a phase 1 open label multicentre study of D-0316 administered orally in patients with advanced NSCLC who have progressed following prior therapy with an EGFR-TKI (Epidermal Growth Factor Recep...
Eligibility Criteria
Inclusion
- Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses
- Histological or cytological confirmation diagnosis of Non Small Cell Lung Cancer (NSCLC).
- Radiological documentation of disease progression while on a previous continuous treatment with an EGFR TKI e.g. gefitinib or erlotinib. In addition other lines of therapy may have been given. All patients must have documented radiological progression on the last treatment administered prior to enrolling in the study.
- Confirmation that the tumour harbours an EGFR T790M mutation.
- No deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks.
- Evaluable or measurable disease per RECIST v1.1
Exclusion
- Treatment with an EGFR TKI (erlotinib or gefitinib) within 14 days of the first dose of study treatment.
- Any cytotoxic chemotherapy, investigational agents or other anticancer drugs from the treatment of advanced NSCLC from a previous treatment regimen or clinical study within 14 days of the first dose of study treatment.
- Other protocol defined inclusion/exclusion criteria could apply
Key Trial Info
Start Date :
January 3 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT03452150
Start Date
January 3 2018
End Date
December 31 2020
Last Update
April 25 2023
Active Locations (3)
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1
Research Site
Changchun, Jilin, China, 130012
2
Research Site
Shanghai, Shanghai Municipality, China, 200030
3
Research Site
Hangzhou, Zhejiang, China, 310052