CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 290 enrolled
Drug / intervention
D-0316drug
Likely dose
D-0316 75mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03861156
NCT03861156Phase 2Completed

A Phase II Study to Assess the Safety and Efficacy of D-0316 in Patients With Locally Advanced/Metastatic Non Small Cell Lung Cancer Whose Tumors Are Epidermal Growth Factor Receptor Mutation Positive

InventisBio Co., Ltd·interventional·Posted Mar 4, 2019·Updated Apr 9, 2024

In Brief

A Phase 2 clinical trial evaluating D-0316 for Solid Tumor and 2 related conditions. Completed, enrolled 290 participants across 1 site.

Detailed 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 Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy and whose Tumours are Epidermal Growth Factor Receptor Mutation and T790M Mutation Positive

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedMar 4, 2019
Enrollment StartFeb 28, 2019
Primary CompletionAug 15, 2021
Study CompletionMay 31, 2023
TodayJul 1, 2026
Enrollment to primary: 2.5 yearsPosted 7.3 years ago

Interventions

D-0316drug

Firstly, D-0316 was orally given 75mg for a cycle(21 days), if tolerated, the dose will be increased to 100mg. Otherwise, the dose will be maintained at 75mg.