Non-small Cell Lung CancerPhase 2NCT02006043
Evaluate Erlotinib Efficacy and Safety as the 2nd/3rd Treatment in NSCLC With EGFR M(-) and C-met(-)
A Phase 2 study testing Erlotinib 150mg in people with Non-small Cell Lung Cancer, run by Li Zhang at 2 sites in China.
Trial summary
evaluate Erlotinib efficacy and safety as the 2nd/3rd line treatment in advanced or recurrent NSCLC with EGFR wild type and without c-met expression Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Erlotinib 150mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 2 sitesChina
- Study dates
- Dec 2013to Dec 2016
- Phase
- Phase 2
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Histologically or cytological documented metastatic (stage IV) or recurrent NSCLC
- Measurable disease must be characterized according to the response evaluation criteria in solid tumors(RECIST1.1) criteria
- Must have at least one prior platinum-based chemotherapy regimen for advanced NSCLC and now exhibit progressive disease (PD), and must have recovered from any serious treatment related toxicity
- Neither with EGFR mutation nor c-met expression on Ventana Benchmark instrument(Met negative expression definition: ≥50% of the cells do not stain or stain with weak intensity (clinical score 0 or 1+) )
- ECOG Performance Status 0 ~2
- Adequate hematological function: Neutrophil count ≥ 1.5 × 109/L, Platelets ≥ 100 × 109/L and Hemoglobin ≥9 g/dL (may be transfused to maintain or exceed this level).
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- Adequate liver function: Total bilirubin ≤ 1.5 × upper limit of normal (ULN); AST (SGOT) and ALT (SGPT) < 2.5 × ULN in the absence of liver metastases, or < 5 × ULN in case of liver metastases.
- Male or female.
- Age ≥ 18 years and ≤75 years
- Written (signed) informed consent. Able to comply with study and follow-up procedures.
Who cannot join
- Patients with prior exposure to agents directed at the HER axis (e.g. erlotinib, gefitinib, cetuximab, trastuzumab).
- Received treatment with any other investigational agent, or participated in another clinical trial, with the following exceptions.
- Chemotherapy-only trials are permitted (if completed≧ 28 days prior to receiving the first dose of study drug).
- Previous adjuvant or neo-adjuvant treatment for nonmetastatic disease is permitted if completed ≥ 6 months before receiving the first dose of study drug; c)Prior surgery is permitted if performed ≥ 4 weeks before receiving the first dose of study drug and the patient is fully recovered.
- Prior localized radiotherapy is permitted if it was not administered to target lesions selected for this study, unless progression of the selected target lesions within the radiation portal is documented, and provided it has been completed ≥ 4 weeks before receiving the first dose of study drug.
- Participation in a methodological or observational study in which no investigational agent was given
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- Patients who have brain metastasis or spinal cord compression that has not yet been definitively treated with surgery and/or radiation; previously diagnosed and treated CNS metastases or spinal cord compression without evidence of stable disease (clinically stable imaging) for at least 2 months
- History of another malignancy in the last 5 years with the exception of the following:
- Other malignancies cured by surgery alone and having a continuous disease-free interval of 5 years are permitted.
- Cured basal cell carcinoma of the skin and cured in situ carcinoma of the uterine cervix are permitted.
- Any significant ophthalmologic abnormality, especially severe dry eye syndrome, keratoconjunctivitis sicca, Sjögren syndrome, severe exposure keratitis or any other disorder likely to increase the risk of corneal epithelial lesions. The use of contact lenses is not recommended during the study. The decision to continue to wear contact lenses should be discussed with the patient's treating oncologist and the ophthalmologist.
- Any diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of any study medication or that might affect the interpretation of the results or render the subject at high risk from treatment complications.
- Female subject who is pregnant or breast-feeding
- Any unstable systemic disease
- Hypersensitivity to erlotinib
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Sun Yat-Sen University cnacer center
Guangzhou, Guangdong, 510030
Ting Zhou, 86-020-87343689, zhouting@sysucc.org.cn
Yan Huang
- Recruiting
Guangxi Medical University cancer center
Nanning, Guangxi, 530021
Hua Huaqing
About this study
Official title: A Phase II, Open, Single Arm Trial to Evaluate Erlotinib Efficacy and Safety as the 2nd/3rd Line Treatment in Advanced or Recurrent NSCLC With EGFR Wild Type and Without C-met Expression
evaluate Erlotinib efficacy and safety as the 2nd/3rd line treatment in advanced or recurrent NSCLC with EGFR wild type and without c-met expression
Read the detailed description
In this phase II, open, single arm study, it will be evaluated of the efficacy and safety of erlotinib in 2nd/3rd line of EGFR WT and c-Met negative advanced NSCLC.The treatment goes as follows:Erlotinib 150mg/day taken orally until disease progression or intolerable toxicities.The primary end point of the study was 6 months PFS rate.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Erlotinib 150mg
- 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.
Erlotinib 150mgDrug
| Study group | Role | What they receive |
|---|---|---|
| Erlotinib 150mg/day taken orally | Experimental | Erlotinib 150mg/day taken orally until disease progression or intolerable toxicities Receives: Drug: Erlotinib 150mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 months PFS rate
Measured: at when last patient enrolled 6 months
Secondary outcomes (2)
overall survival, OS
Measured: at when last patient enrolled 18 months
objective response rate, ORR
Measured: at when last patient enrolled 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionDec 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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Li Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Li Zhang, Sun Yat-sen University
- Investigators
- Li Zhang, Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02006043
- Sponsor's protocol ID
- ML28941
- Status last verified
- Jul 2015
- First submitted
- 26 Nov 2013
- Last updated
- 3 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open, Single Arm Trial to Evaluate Erlotinib Efficacy and Safety as the 2nd/3rd Line Treatment in Advanced or Recurrent NSCLC With EGFR Wild Type and Without C-met Expression
- ClinicalTrials.gov ID
- NCT02006043
- Acronym / sponsor ID
- ML28941
- Conditions
- Non-small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Li ZhangUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Dec 2016 (estimated)
- First posted
- 9 Dec 2013 (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.
evaluate Erlotinib efficacy and safety as the 2nd/3rd line treatment in advanced or recurrent NSCLC with EGFR wild type and without c-met expression
Detailed description
In this phase II, open, single arm study, it will be evaluated of the efficacy and safety of erlotinib in 2nd/3rd line of EGFR WT and c-Met negative advanced NSCLC.The treatment goes as follows:Erlotinib 150mg/day taken orally until disease progression or intolerable toxicities.The primary end point of the study was 6 months PFS rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Erlotinib 150mg/day taken orally | Experimental | Drug: Erlotinib 150mgErlotinib 150mg/day taken orally until disease progression or intolerable toxicities |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically or cytological documented metastatic (stage IV) or recurrent NSCLC
- Measurable disease must be characterized according to the response evaluation criteria in solid tumors(RECIST1.1) criteria
- Must have at least one prior platinum-based chemotherapy regimen for advanced NSCLC and now exhibit progressive disease (PD), and must have recovered from any serious treatment related toxicity
- Neither with EGFR mutation nor c-met expression on Ventana Benchmark instrument(Met negative expression definition: ≥50% of the cells do not stain or stain with weak intensity (clinical score 0 or 1+) )
- ECOG Performance Status 0 ~2
Key exclusion criteria (15 listed)
- Patients with prior exposure to agents directed at the HER axis (e.g. erlotinib, gefitinib, cetuximab, trastuzumab).
- Received treatment with any other investigational agent, or participated in another clinical trial, with the following exceptions.
- Patients who have brain metastasis or spinal cord compression that has not yet been definitively treated with surgery and/or radiation; previously diagnosed and treated CNS metastases or spinal cord compression without evidence of stable disease (clinically stable imaging) for at least 2 months
- History of another malignancy in the last 5 years with the exception of the following:
- Any significant ophthalmologic abnormality, especially severe dry eye syndrome, keratoconjunctivitis sicca, Sjögren syndrome, severe exposure keratitis or any other disorder likely to increase the risk of corneal epithelial lesions. The use of contact lenses is not recommended during the study. The decision to continue to wear contact lenses should be discussed with the patient's treating oncologist and the ophthalmologist.
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 |
|---|---|---|
| Erlotinib 150mg | Drug | Erlotinib 150mg/day taken orally |
Primary outcome
6 months PFS rate
Time frame: at when last patient enrolled 6 months
2 secondary outcomes
overall survival, OS
Time frame: at when last patient enrolled 18 months
objective response rate, ORR
Time frame: at when last patient enrolled 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 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.
Li Zhang principal investigator
Sun Yat-Sen University Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Erlotinib 150mg in people with Non-small Cell Lung Cancer, run by Li Zhang at 2 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 10 inclusion and 15 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 3 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Ting Zhou (86-020-87343689, zhouting@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 months PFS rate (time frame: at when last patient enrolled 6 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 3 Jul 2015.