Advanced Non Small Cell Lung CancerPhase 1NCT03452150
D-0316 First Time in Patients Ascending Dose Study
A Phase 1 study testing D-0316 in people with Advanced Non Small Cell Lung Cancer, run by InventisBio Co., Ltd at 3 sites in China.
Trial 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 Receptor tyrosine kinase inhibitor agent). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Non Small Cell Lung Cancer
- What is being tested?
- D-0316
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 3 sitesChina
- Study dates
- 3 Jan 2018to 31 Dec 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
China3 sites
Research Site
Changchun, Jilin, 130012
Research Site
Hangzhou, Zhejiang, 310052
Research Site
Shanghai, Shanghai Municipality, 200030
About this study
Official title: A Phase I Study of D-0316 in Patients With Advanced Non Small Cell Lung Cancer With Mutation of Epidermal Growth Factor Receptor Tyrosine Kinase
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 Receptor tyrosine kinase inhibitor agent). This is the first time this drug has ever been tested in patients, and so it will help to understand safety, tolerability, pharmacokinetics and preliminary anti-tumour activity of ascending doses of D-0316.
- Conditions
- Advanced Non Small Cell Lung Cancer
- Being tested
- D-0316
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-0316Drug
If initial dosing of D-0316 is tolerated then subsequent cohorts will test increasing doses until a maximum tolerated dose or maximum feasible dose is defined
| Study group | Role | What they receive |
|---|---|---|
| Daily oral dose of D-0316 | Experimental | Not described Receives: Drug: D-0316 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicities (DLTs)
Incidence of DLTs
Measured: Day 1 - Day 28
Adverse events
Incidence of AEs
Measured: Day 1 - Day 28
Laboratory results
Incidence of laboratory abnormalities
Measured: Day 1 - Day 28
Vital signs
Incidence of vital sign abnormalities
Measured: Day 1 - Day 28
Electrocardiogram
Incidence of ECG abnormalities
Measured: Day 1 - Day 28
Secondary outcomes (5)
Pharmacokinetic: area under the plasma concentration versus time curve (AUC)
AUC: area under the plasma concentration versus time curve for D-0316
Measured: Day 1 through 6, Cycle Day 1-Day 15
Pharmacokinetic: maximum plasma drug concentration (Cmax)
Cmax: maximum plasma drug concentration of D-0316
Measured: Day 1 through 6, Cycle Day 1-Day 15
Pharmacokinetic: Time to reach the Cmax (Tmax)
tmax: Time to reach the Cmax of D-0316
Measured: Day 1 through 6, Cycle Day 1-Day 15
Pharmacokinetic: Apparent terminal half-life (t1/2)
t1/2: apparent terminal half-life of D-0316
Measured: Day 1 through 6, Cycle Day 1-Day 15
Antitumor activity
Antitumor activity by evaluation of tumor response assessments using Response Evaluation Criteria in Solid Tumours (RECIST 1.1)
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2018
- Study start3 Jan 2018
- Primary completion28 Aug 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Non Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- InventisBio Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03452150
- Sponsor's protocol ID
- XY-101
- Status last verified
- Apr 2023
- First submitted
- 13 Feb 2018
- Last updated
- 25 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jian H, Wang K, Cheng Y, Ding L, Wang Y, Shi Z, Zhang L, Wang Y, Lu S. Phase I Trial of a Third Generation EGFR Mutant-Selective Inhibitor (D-0316) in Patients with Advanced Non-Small Cell Lung Cancer. Oncologist. 2022 Mar 11;27(3):163-e213. doi: 10.1093/oncolo/oyab007.
PubMed 35274722
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of D-0316 in Patients With Advanced Non Small Cell Lung Cancer With Mutation of Epidermal Growth Factor Receptor Tyrosine Kinase
- ClinicalTrials.gov ID
- NCT03452150
- Acronym / sponsor ID
- XY-101
- Conditions
- Advanced Non Small Cell Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- InventisBio Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 3 Jan 2018 (actual)
- Primary completion
- 28 Aug 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 2 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 Receptor tyrosine kinase inhibitor agent). This is the first time this drug has ever been tested in patients, and so it will help to understand safety, tolerability, pharmacokinetics and preliminary anti-tumour activity of ascending doses of D-0316.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Daily oral dose of D-0316 | Experimental | Drug: D-0316 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| D-0316If initial dosing of D-0316 is tolerated then subsequent cohorts will test increasing doses until a maximum tolerated dose or maximum feasible dose is defined | Drug | Daily oral dose of D-0316 |
Primary outcome
Dose Limiting Toxicities (DLTs)
Time frame: Day 1 - Day 28
Incidence of DLTs
Adverse events
Time frame: Day 1 - Day 28
Incidence of AEs
Laboratory results
Time frame: Day 1 - Day 28
Incidence of laboratory abnormalities
Vital signs
Time frame: Day 1 - Day 28
Incidence of vital sign abnormalities
Electrocardiogram
Time frame: Day 1 - Day 28
Incidence of ECG abnormalities
5 secondary outcomes
Pharmacokinetic: area under the plasma concentration versus time curve (AUC)
Time frame: Day 1 through 6, Cycle Day 1-Day 15
Pharmacokinetic: maximum plasma drug concentration (Cmax)
Time frame: Day 1 through 6, Cycle Day 1-Day 15
Pharmacokinetic: Time to reach the Cmax (Tmax)
Time frame: Day 1 through 6, Cycle Day 1-Day 15
Pharmacokinetic: Apparent terminal half-life (t1/2)
Time frame: Day 1 through 6, Cycle Day 1-Day 15
Antitumor activity
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Derived from this study: PubMed 35274722Jian H, Wang K, Cheng Y, Ding L, Wang Y, Shi Z, Zhang L, Wang Y, Lu S. Phase I Trial of a Third Generation EGFR Mutant-Selective Inhibitor (D-0316) in Patients with Advanced Non-Small Cell Lung Cancer. Oncologist. 2022 Mar 11;27(3):163-e213. doi: 10.1093/oncolo/oyab007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing D-0316 in people with Advanced Non Small Cell Lung Cancer, run by InventisBio Co., Ltd at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limiting Toxicities (DLTs) (time frame: Day 1 - Day 28). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03452150, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2023.