- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03861156
D-0316 in Patients With EGFR Positive Non Small Cell Lung Cancer
April 8, 2024 updated by: InventisBio Co., Ltd
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
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 Overview
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 100mg.
Otherwise, the dose will be maintained at 75mg.) in patients with a confirmed diagnosis of Epidermal Growth Factor Receptor mutation positive and T790M mutation positive NSCLC,who have progressed following prior therapy with an approved Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI) agent.
The primary objective of the study is to assess the efficacy of D-0316 by assessment of Objective Response Rate according to RECIST 1.1 by an Independent Central Review.
Study Type
Interventional
Enrollment (Actual)
290
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shanghai
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Shanghai, Shanghai, China, 200030
- Shanghai Chest Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: D-0316
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective response rate based on independent radiology review
Time Frame: 24 months
|
ORR per RECIST 1.1 calculated as the proportion of patients with a best overall response defined as complete response (CR) or partial response (PR).
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free survival (PFS) as assessed by independent radiology review and investigator
Time Frame: 36 months
|
PFS, defined as time from first dose of X-396 to progression or death due to any cause.
|
36 months
|
Overall survival (OS)
Time Frame: 36 months
|
OS, defined as time from first dose of X-396 to death due to any cause.
|
36 months
|
Duration of response(DoR)
Time Frame: 24 months
|
DoR, defined as time from first reponse to disease progression or death
|
24 months
|
Disease control rate(DCR)
Time Frame: 24 months
|
DCR, defined as proportion of complete response, partial response, and disease stabilization to the proportion of patients with evaluable tumors.
|
24 months
|
Intracranial Progression-free survival(iPFS)
Time Frame: 36 months
|
iPFS, defined as the time between baseline brain metastases, from the date of study drug administration to the time between the onset of intracranial tumor progression or death.
|
36 months
|
Intracranial objective response rate(iORR)
Time Frame: 24 months
|
iORR, defined as the proportion of subjects with complete intracranial response, partial intracranial response to subjects with brain metastases at baseline.
|
24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Shun Lu, Shanghai Chest Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 28, 2019
Primary Completion (Actual)
August 15, 2021
Study Completion (Actual)
May 31, 2023
Study Registration Dates
First Submitted
March 1, 2019
First Submitted That Met QC Criteria
March 1, 2019
First Posted (Actual)
March 4, 2019
Study Record Updates
Last Update Posted (Actual)
April 9, 2024
Last Update Submitted That Met QC Criteria
April 8, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IBIO-102
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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