Non-small Cell Lung CancerNCT01951755
Phase IV Study of Tarceva in Patients With Advanced Stage IIIB/ IV Non-small Cell Lung Cancer (NSCLC)
An observational study of Non-small Cell Lung Cancer, run by University of Athens at 1 site in Greece.
Trial summary
An open-label, non randomized clinical trial of Tarceva as single agent in progressed non-small cell lung cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- How many people
- 150 participants
- Where
- 1 siteGreece
- Study dates
- Jan 2012to Jan 2014
- How long will I take part?
- 24 Months
- Phase
- Observational
- 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
Study population: Patients with advanced (inoperable stage IIIB or stage IV) NSCLC who had failed in platinum based chemotherapy
Who may be able to join
- Histological or cytological documented diagnosis diagnosis of inoperable, locally advanced, recurrent or metastatic (Stage IIIB or IV) NSCLC.
- Patients must have evidence of disease but measurable disease is not mandatory.
- 18 years of age or older.
- ECOG Performance Status of 0-2.
- Life expectancy at least 12 weeks.
- Patients with advanced stage IIIB/ IV NSCLC who have received at least one course of standard systemic chemotherapy or radiation therapy or who are in the investigator's opinion not medically suitable for chemotherapy or radiotherapy.
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- No more than 2 prior chemotherapy regimens are permissible. Patients must have recovered from any toxic effects and at least 3-4 weeks must have elapsed from the last dose and prior to registration (14 days for vinorelbine or other vinca alkaloids or gemcitabine). Patients who, in the opinion of the investigator, have fully recovered from surgery in less than 4 weeks may also be considered for the study. Patients must have recovered (CTC ≤ 1) from acute toxicities of any previous therapy.
- Granulocyte count ≥ 1.5 x 109/L and platelet count > 100 x 109/L.
- Serum bilirubin must be ≤ 1.5 upper limit of normal (ULN).
- AST and/or ALT ≤ 2 x ULN (or ≤ 5 x ULN if clearly attributable to liver metastasis.
- Serum creatinine ≤ 1.5 ULN or creatinine clearance ≥ 60 ml/min.
- Able to comply with study and follow-up procedures.
- For all females of childbearing potential a negative pregnancy test must be obtained within 72 hours before starting therapy.
- Patients with reproductive potential must use effective contraception.
- Written (signed) Informed Consent to participate in the study.
Who cannot join
- Any unstable systemic disease (including active infection, grade 4 hypertension, unstable angina, congestive heart failure, hepatic, renal or metabolic disease).
- Prior therapy with systemic anti-tumour therapy with HER1/EGFR inhibitors (as small molecule or monoclonal antibody therapy).
- Any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer).
- Patients are excluded if they have brain metastasis or spinal cord compression that is newly diagnosed and/ or has not yet been definitively treated with surgery and/ or radiation; previously diagnosed and treated CNS metastases or spinal cord compression with evidence of stable disease (clinically stable imaging) for at least 2 months is permitted.
- Any significant ophthalmologic abnormality, especially severe dry eye syndrome, keratoconjunctivitis sicca, Sjogren 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.
- Patients who cannot take oral medication, who require intravenous alimentation, have had prior surgical procedures affecting absorption, or have active peptic ulcer disease.
- Nursing mothers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Observational Study for Safety and Efficacy of Erlotinib Beyond 1st Line in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer
An open-label, non randomized clinical trial of Tarceva as single agent in progressed non-small cell lung cancer patients.
Read the detailed description
An observational non randomized clinical trial of Tarceva as single agent in progressed non-small cell lung cancer patients after chemotherapy.
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- Inoperable NSCLC, TKIs
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Defined as the time period from the entry to the study until assessed disease progression or death
Measured: 24 months
Secondary outcomes (1)
Safety
Adverse events and serious adverse events
Measured: Baseline, 4-6 months, 12 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2013 (estimated)
- Study startJan 2012
- Primary completionJan 2014
- Study completionJan 2014
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kostas N Syrigos, University of Athens
- Investigators
- KOSTAS N SYRIGOS, MD, PhD, Study chair, Oncology Unit University of Athens, Sotiria Hosp, 152 Mesogion Av
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01951755
- Sponsor's protocol ID
- ML27805
- Status last verified
- Dec 2014
- First submitted
- 19 Sep 2013
- Last updated
- 8 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study for Safety and Efficacy of Erlotinib Beyond 1st Line in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT01951755
- Acronym / sponsor ID
- ML27805
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- Inoperable NSCLC, TKIs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of AthensUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 27 Sep 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.
An open-label, non randomized clinical trial of Tarceva as single agent in progressed non-small cell lung cancer patients.
Detailed description
An observational non randomized clinical trial of Tarceva as single agent in progressed non-small cell lung cancer patients after chemotherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with advanced (inoperable stage IIIB or stage IV) NSCLC who had failed in platinum based chemotherapy
Key inclusion criteria (15 listed)
- Histological or cytological documented diagnosis diagnosis of inoperable, locally advanced, recurrent or metastatic (Stage IIIB or IV) NSCLC.
- Patients must have evidence of disease but measurable disease is not mandatory.
- 18 years of age or older.
- ECOG Performance Status of 0-2.
- Life expectancy at least 12 weeks.
Key exclusion criteria (7 listed)
- Any unstable systemic disease (including active infection, grade 4 hypertension, unstable angina, congestive heart failure, hepatic, renal or metabolic disease).
- Prior therapy with systemic anti-tumour therapy with HER1/EGFR inhibitors (as small molecule or monoclonal antibody therapy).
- Any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer).
- Patients are excluded if they have brain metastasis or spinal cord compression that is newly diagnosed and/ or has not yet been definitively treated with surgery and/ or radiation; previously diagnosed and treated CNS metastases or spinal cord compression with evidence of stable disease (clinically stable imaging) for at least 2 months is permitted.
- Any significant ophthalmologic abnormality, especially severe dry eye syndrome, keratoconjunctivitis sicca, Sjogren 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.
Primary outcome
Progression Free Survival
Time frame: 24 months
Defined as the time period from the entry to the study until assessed disease progression or death
1 secondary outcome
Safety
Time frame: Baseline, 4-6 months, 12 months, 24 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 8 Dec 2014.
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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.
KOSTAS N SYRIGOS, MD, PhD study chair
Oncology Unit University of Athens, Sotiria Hosp, 152 Mesogion Av
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-small Cell Lung Cancer, run by University of Athens at 1 site in Greece.
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 15 inclusion and 7 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 8 Dec 2014. 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 Greece. 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.
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?
Progression Free Survival (time frame: 24 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 8 Dec 2014.