Status:
COMPLETED
D-0316 in Patients With EGFR Positive Non Small Cell Lung Cancer
Lead Sponsor:
InventisBio Co., Ltd
Conditions:
Solid Tumor
NSCLC
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
A Phase II, Open Label, Single-arm Study to Assess the Safety and Efficacy of D-0316 in Patients with Locally Advanced/Metastatic Non Small Cell Lung Cancer whose Disease has Progressed with Previous ...
Detailed Description
This is a phase II, open label, single arm study assessing the safety and efficacy of D-0316 (Firstly, D-0316 was orally given 75mg for a cycle(21 days), if tolerated, the dose will be increased to 10...
Eligibility Criteria
Inclusion
- Aged at least 18 years.
- Histologically or cytologically proven diagnosis of NSCLC that is locally advanced or metastatic.
- Radiological documentation of disease progression while on a previous continuous treatment with an first or second generation of EGFR TKI e.g. gefitinib or erlotinib.
- patients must also have confirmation of tumour T790M mutation status (confirmed positive) after disease progression on the prior EGFR TKI.
- Eastern cooperative oncology group performance status (ECOG PS) of 0-1.
- a minimum life expectancy of 12 weeks.
- At least one lesion, not previously irradiated during the study screening period, that can be accurately measured at baseline according to RECIST 1.1.
- Agree to use routine adequate and effective contraceptive measures during the entire study period and within 6 weeks after the last dose pre-menopausal fertility possible; Female patients need to exclude pregnancy (ie negative pregnancy test) and in non-lactation period.
Exclusion
- Treatment with a first or second generation of EGFR-TKI within 10 days of study entry; previous treatment with a third generation of EGFR-TKI.
- Unresolved toxicities from prior therapy.
- Unstable spinal cord compression/brain metastases.
- Severe/uncontrolled systemic diseases, including uncontrolled hypertension, bleeding diatheses or infection.
- QTcF≥470 msec（female）or QTcF≥450 msec（male）during the screening period.
- Severe respiratory diseases such as interstitial lung disease, severe asthma, pulmonary embolism, etc.
- previous treatment with 2 or more lines of Chemotherapy or immunotherapy.
Key Trial Info
Start Date :
February 28 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2023
Estimated Enrollment :
290 Patients enrolled
Trial Details
Trial ID
NCT03861156
Start Date
February 28 2019
End Date
May 31 2023
Last Update
April 9 2024
Active Locations (1)
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1
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China, 200030