NSCLCPhase 3NCT02140333
Erlotinib 100mg or 150mg in Treating EGFR Mutated NSCLC
A Phase 3 study testing Erlotinib in people with NSCLC and EGFR Mutation, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial summary
The purpose of this study is to determine whether 100mg erlotinib had similar effect compared with 150mg erlotinib in NSCLC patients with EGFR mutation in China. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC, EGFR Mutation
- What is being tested?
- Erlotinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteChina
- Study dates
- Aug 2013to Dec 2018
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological diagnosis of NSCLC with phase IIIB or IV disease;
- Sensitive mutation EGFR gene (18, 19 del, 21 L858R gene mutation) (mutation detection methods:ARMS-PCR, sequence method)
- Never received anti-tumor therapies for the advanced stage;
- Never used EGFR inhibitors;
- Measurable disease by RECIST criteria;
- Male or female patients >=18 years of age;
- ECOG karnofsky performance 0~3, life expectancy is greater than 12 weeks;
- Patients must be accessible for treatment and follow-up;
Who cannot join
- Previously used EGFR inhibitors
- Mix ingredients in patients with squamous cell carcinoma, small cell lung cancer;
- Allergic to erlotinib;
- Non-measurable lesions
- Pregnant or lactating women;
- Patients having other factors that preventing researchers from enrollment them.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangzhou medical university
Guanzhou, Guangdong, 510120
jianxing he, PhD, 86-20-83062821, drjianxing.he@gmail.com
jianxing he, PhD
About this study
Official title: Phase 3 Study of Erlotinib 100mg or 150mg in Treating EGFR Mutated Patients With Non-small Cell Lung Cancer
The purpose of this study is to determine whether 100mg erlotinib had similar effect compared with 150mg erlotinib in NSCLC patients with EGFR mutation in China.
Read the detailed description
In China it was confirmed that 150mg Erlotinib was effective in NSCLC patients wtih EGFR mutation, but reducing dose occurring in some patients because of the drug related side-effects. Thus, we sought to investigate that in Chinese patients with EGFR mutation whether low dose (100mg) Erlotinib had similar efficacy but lower toxcities compared with standad dose (150mg) Erlotinib.
- Conditions
- NSCLC, EGFR Mutation
- Being tested
- Erlotinib
- Keywords
- erlotinib, EGFR mutation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErlotinibDrug
Also called tarceva
100mg vs. 150mg
| Study group | Role | What they receive |
|---|---|---|
| Erlotinib 100mg | Experimental | Erlotinib 100mg Receives: Drug: Erlotinib |
| Erlotinib 150mg | Active comparator | Erlotinib 150mg Receives: Drug: Erlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Measured: 2 years after the initial dose
Secondary outcomes (1)
The objective response rate
Measured: Patients will be followed for an expected average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2014 (estimated)
- Study startAug 2013
- Primary completionAug 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Guangzhou Medical UniversityThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianxing He, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02140333
- Sponsor's protocol ID
- FAHG20130819
- Other IDs
- GZMC201301
- Status last verified
- Feb 2015
- First submitted
- 5 Oct 2013
- Last updated
- 12 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Study of Erlotinib 100mg or 150mg in Treating EGFR Mutated Patients With Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT02140333
- Acronym / sponsor ID
- FAHG20130819
- Conditions
- NSCLC, EGFR Mutation
- Keywords
- erlotinib, EGFR mutation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 16 May 2014 (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.
The purpose of this study is to determine whether 100mg erlotinib had similar effect compared with 150mg erlotinib in NSCLC patients with EGFR mutation in China.
Detailed description
In China it was confirmed that 150mg Erlotinib was effective in NSCLC patients wtih EGFR mutation, but reducing dose occurring in some patients because of the drug related side-effects. Thus, we sought to investigate that in Chinese patients with EGFR mutation whether low dose (100mg) Erlotinib had similar efficacy but lower toxcities compared with standad dose (150mg) Erlotinib.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erlotinib 100mg | Experimental | Drug: ErlotinibErlotinib 100mg |
| Erlotinib 150mg | Active comparator | Drug: ErlotinibErlotinib 150mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histological diagnosis of NSCLC with phase IIIB or IV disease;
- Sensitive mutation EGFR gene (18, 19 del, 21 L858R gene mutation) (mutation detection methods:ARMS-PCR, sequence method)
- Never received anti-tumor therapies for the advanced stage;
- Never used EGFR inhibitors;
- Measurable disease by RECIST criteria;
Key exclusion criteria (6 listed)
- Previously used EGFR inhibitors
- Mix ingredients in patients with squamous cell carcinoma, small cell lung cancer;
- Allergic to erlotinib;
- Non-measurable lesions
- Pregnant or lactating women;
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 |
|---|---|---|
| ErlotinibAlso: tarceva100mg vs. 150mg | Drug | Erlotinib 100mg, Erlotinib 150mg |
Primary outcome
Progression free survival
Time frame: 2 years after the initial dose
1 secondary outcome
The objective response rate
Time frame: Patients will be followed for an expected average of 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Erlotinib in people with NSCLC and EGFR Mutation, run by The First Affiliated Hospital of Guangzhou Medical University 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 8 inclusion and 6 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 12 Feb 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact jianxing He, PhD (86-20-83062821, drjianxing.he@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: 2 years after the initial dose). 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 12 Feb 2015.