Non-Small Cell Lung CancerPhase 4NCT01646450
First-line Treatment With Icotinib in Elder NSCLC EGFR Mutated Patients
A Phase 4 study testing Icotinib in people with Non-Small Cell Lung Cancer, run by Betta Pharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
A single arm, open label, phase IV trial to evaluate safety and efficacy of icotinib as first-line treatment for the elder patients with advanced or metastatic (IIIb and IV) NSCLC and mutated EGFR. Read more about this study
- Who is it for?
- Ages 70 to 80 years
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Icotinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- Jul 2012to Apr 2016
- Phase
- Phase 4
- 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 70 to 80 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Recurrent or progressive Non-Small Cell Lung Cancer stage IV or IIIB patients.
- Positive EGFR Mutation.
- No previous systemic anticancer therapy.
- Male and female patients aged over 70 years.
- Measurable lesion according to RECIST with at least one measurable lesion not previously irradiated, unless disease progression has been documented at that site.
- Provision of written informed consent.
Who cannot join
- Evidence of clinically active Interstitial Lung Diseases (Patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded).
- Known severe hypersensitivity to icotinib or any of the excipients of this product.
- Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Chest Hospital Affliated to Shanghai Jiaotong Univercity
Shanghai, Shanghai Municipality, 200030
About this study
Official title: An Open Lable, Single Arm, Phase IV Study of Icotinib as First-line Treatment in Elder NSCLC Patients With EGFR Mutation
A single arm, open label, phase IV trial to evaluate safety and efficacy of icotinib as first-line treatment for the elder patients with advanced or metastatic (IIIb and IV) NSCLC and mutated EGFR.
Read the detailed description
A single arm, open label, prospective, phase IV trial to evaluate safety and efficacy of icotinib as first-line treatment for the elder patients with advanced or metastatic (IIIb and IV) NSCLC and mutated EGFR.
- Primary endpoint to assess progression-free survival
- Secondary endpoints to assess the overall survival, objective response rate, disease control rate and so on.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Icotinib
- Keywords
- NSCLC, EGFR Mutation, Elder patients
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IcotinibDrug
Also called BPI-2009, Commana
Icotinib: 125mg, oral administration, three times per day.
| Study group | Role | What they receive |
|---|---|---|
| Icotinib | Experimental | Icotinib: 125mg, oral administration, three times per day. Receives: Drug: Icotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
PFS was defined as the time from the date of first dose of study medication to the date of first documentation of tumor progression or death due to any cause, whichever occurred first.
Measured: 12 months
Secondary outcomes (3)
Overall survival
Overall Survival was assessed via calculation of the time to death due to any cause. If a participant was known to have died, the time to death was defined as the time from the date of randomization to the date of death. Otherwise, a participant was censored at the last date they were known to be alive.
Measured: 24 months
Objective response rate
Number of participants with an objective response. An objective response (OR) was defined as a patient having a best overall response of either complete response (CR) or partial response (PR) according to RECIST, confirmed at least 28 days following the date of the initial response.
Measured: 3-6 months
Number of Participants with Adverse Events as a Measure of Safety
Adverse events, Serious adverse events , incidence of and reason for study drug dose interruptions and discontinuations, laboratory assessments, vital signs.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionDec 2015 (estimated)
- Study completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Betta Pharmaceuticals Co., Ltd.The sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Betta Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Han Baohui, MD, Principal investigator, Shanghai Chest Hospital Affliated to Shanghai Jiaotong Univercity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01646450
- Sponsor's protocol ID
- BD-IC-IV20
- Status last verified
- Sep 2015
- First submitted
- 17 Jul 2012
- Last updated
- 9 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Lable, Single Arm, Phase IV Study of Icotinib as First-line Treatment in Elder NSCLC Patients With EGFR Mutation
- ClinicalTrials.gov ID
- NCT01646450
- Acronym / sponsor ID
- BD-IC-IV20
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- NSCLC, EGFR Mutation, Elder patients
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Betta Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 20 Jul 2012 (estimated)
- 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.
A single arm, open label, phase IV trial to evaluate safety and efficacy of icotinib as first-line treatment for the elder patients with advanced or metastatic (IIIb and IV) NSCLC and mutated EGFR.
Detailed description
A single arm, open label, prospective, phase IV trial to evaluate safety and efficacy of icotinib as first-line treatment for the elder patients with advanced or metastatic (IIIb and IV) NSCLC and mutated EGFR.
- Primary endpoint to assess progression-free survival
- Secondary endpoints to assess the overall survival, objective response rate, disease control rate and so on.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Icotinib | Experimental | Drug: IcotinibIcotinib: 125mg, oral administration, three times per day. |
Who may qualify
- Ages
- 70 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Recurrent or progressive Non-Small Cell Lung Cancer stage IV or IIIB patients.
- Positive EGFR Mutation.
- No previous systemic anticancer therapy.
- Male and female patients aged over 70 years.
- Measurable lesion according to RECIST with at least one measurable lesion not previously irradiated, unless disease progression has been documented at that site.
Key exclusion criteria (3 listed)
- Evidence of clinically active Interstitial Lung Diseases (Patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded).
- Known severe hypersensitivity to icotinib or any of the excipients of this product.
- Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study.
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 |
|---|---|---|
| IcotinibAlso: BPI-2009, CommanaIcotinib: 125mg, oral administration, three times per day. | Drug | Icotinib |
Primary outcome
Progression free survival
Time frame: 12 months
PFS was defined as the time from the date of first dose of study medication to the date of first documentation of tumor progression or death due to any cause, whichever occurred first.
3 secondary outcomes
Overall survival
Time frame: 24 months
Objective response rate
Time frame: 3-6 months
Number of Participants with Adverse Events as a Measure of Safety
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2015.
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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.
Han Baohui, MD principal investigator
Shanghai Chest Hospital Affliated to Shanghai Jiaotong Univercity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Icotinib in people with Non-Small Cell Lung Cancer, run by Betta Pharmaceuticals Co., Ltd. at 1 site 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: status not confirmed, as of the sponsor's last update on 9 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Progression free survival (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Sep 2015.