Carcinoma, Squamous CellGGCP 055/12NCT02328391
STUDY OBSERVATIONAL OF ERLOTINIB AS SECOND LINE TREATMENT IN PATIENTS WITH SQUAMOUS NSCLC AND EGFR NATIVE
An observational study of Carcinoma, Squamous Cell, run by Grupo Gallego de Cancer de Pulmon at 1 site in Spain.
Trial summary
OBJECTIVE study the effectiveness of the administration of Erlotinib 150 mg/Day v.o. in second-line treatment in patients with lung cancer advanced non-small of histology predominantly flaky by assessing the survival free of progression (SLP). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Squamous Cell
- How many people
- 51 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2013to Dec 2015
- How long will I take part?
- 8 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: Adult patients with diagnosis of NSCLC with predominantly squamous histology. The subject shall be considered included in the study when, fulfilling the criteria of selection, accept their participation therein by the signing of informed consent.
Who may be able to join
- -• Age ≥ 18 years.
- Histological or cytologic diagnosis of cancer (NSCLC) with predominantly squamous histology stage IV non-small-cell lung.
- ECOG performance status between 0 and 2.
- Patients who have progressed to a first line of advanced disease and are eligible for a second line with Erlotinib.
- Patients that grant informed, preferably in writing, or oral consent before witnesses independent of the research team.
Who cannot join
- -• Patients with uncontrolled or severe systemic disease, an active infection, neoplasia concomitant or secondary neoplasia to primary disease, except for carcinoma in situ of cervix or adequately treated skin carcinoma.
- Disease with mutated EGFR, according to local laboratory. The determination of the EGFR is not mandatory. Those patients from centers where there is the determination of the EGFR or those patients that the EGFR is unknown may be included in.
- Inability to take oral medication or previous surgical procedures that affect the absorption and imply the need for intravenous or parenteral feeding.
- Interstitial lung disease clinically active.
- Unstable angina or recent myocardial infarction.
- Brain metastasis uncontrolled and progressive.
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- Patients who are participating in a clinical trial.
- Use of an inhibitor of tyrosine kinase in first line of treatment.
- Patients whose estimated life expectancy does not reach the 2 months.
- Any condition, situation which, in the opinion of the investigator, may endanger the safety of the patient, or could interfere significantly with the involvement of the subject in the study or evaluation of the results of the study.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Grupo Gallego Cancer de Pulmon
Santiago de Compostela, A Coruña
Raquel Romero, Chemestry, +34982296459, raquel.romero.van.der.schoot@sergas.es
Sergio Vázquez Estévez, Oncologist
About this study
Official title: MULTICENTER, PROSPECTIVE, OBSERVATIONAL OF ERLOTINIB AS SECOND-LINE TREATMENT IN PATIENTS WITH NON-SMALL CELL (NSCLC) LUNG CANCER WITH PREDOMINANTLY SQUAMOUS HISTOLOGY AND CARRIERS OF THE GENE (EGFR) EPIDERMAL GROWTH FACTOR RECEPTOR NATIVE
OBJECTIVE study the effectiveness of the administration of Erlotinib 150 mg/Day v.o. in second-line treatment in patients with lung cancer advanced non-small of histology predominantly flaky by assessing the survival free of progression (SLP).
Design Studio postautoritation of multicenter observational follow-up prospective (EPA-SP) type.
Read more
DISEASE OTRASTORNO A study of cell Lung Cancer not small (NSCLC). MEDICATION object data to study the drug under study is erlotinib.
-Dose and treatment guidelines follow the corresponding product sheet. Management of dosage and adverse effects specified in point H. 15 of the Protocol.
POPULATION in study and number TOTAL of subjects population under study: adult patients with diagnosis of NSCLC with predominantly squamous histology total number of subjects: the participation of approximately 51 patients is expected DISEASE OR DISORDER TO STUDY Non Small Cell Lung Cancer (NSCLC). MEDICATION DATA OBJECT OF STUDY The drug under study is erlotinib.
-Dose and treatment guidelines Follow the corresponding product sheet. Management of dosage and adverse effects specified in point H. 15 of the Protocol.
STUDY POPULATION AND NUMBER TOTAL OF SUBJECTS Study: adult patients with diagnosis of NSCLC with predominantly squamous histology total number of subjects: the participation of approximately 51 patients is expected.
- Conditions
- Carcinoma, Squamous Cell
- Medical subject headings
- Carcinoma, Squamous Cell
What is being measured
The primary outcome is the main question the study is designed to answer.
Study the effectiveness of the administration of Erlotinib in 2nd line treatment in patients with advanced NSCLC scaly through assessment of the SLP
Measured: Collect the available information of the visits made by the patient according to the usual practice up to a max of 9 m after the inclusion of the last patient.
Secondary outcomes (1)
Determination TR y TCE. • Determinar SG. • Identificar los diferentes factores pronósticos relacionados con la SLP y SG. • Determinar el perfil de seguridad del tratamiento.
Measured: Collect the available information of the visits made by the patient according to the usual practice up to a max of 9 m after the inclusion of the last patient.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2014 (estimated)
- Study startSep 2013
- Primary completionMar 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Squamous CellStudies 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
- 51 participants (estimated)
- Target duration
- 8 Months
Sponsor and investigators
- Lead sponsor
- Grupo Gallego de Cancer de Pulmon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02328391
- Sponsor's protocol ID
- GGC-ERL-2012-01
- Acronym
- GGCP 055/12
- Status last verified
- Sep 2014
- First submitted
- 24 Apr 2014
- Last updated
- 31 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MULTICENTER, PROSPECTIVE, OBSERVATIONAL OF ERLOTINIB AS SECOND-LINE TREATMENT IN PATIENTS WITH NON-SMALL CELL (NSCLC) LUNG CANCER WITH PREDOMINANTLY SQUAMOUS HISTOLOGY AND CARRIERS OF THE GENE (EGFR) EPIDERMAL GROWTH FACTOR RECEPTOR NATIVE
- ClinicalTrials.gov ID
- NCT02328391
- Acronym / sponsor ID
- GGCP 055/12 / GGC-ERL-2012-01
- Conditions
- Carcinoma, Squamous Cell
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Grupo Gallego de Cancer de PulmonUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Mar 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 31 Dec 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.
OBJECTIVE study the effectiveness of the administration of Erlotinib 150 mg/Day v.o. in second-line treatment in patients with lung cancer advanced non-small of histology predominantly flaky by assessing the survival free of progression (SLP).
Design Studio postautoritation of multicenter observational follow-up prospective (EPA-SP) type.
DISEASE OTRASTORNO A study of cell Lung Cancer not small (NSCLC). MEDICATION object data to study the drug under study is erlotinib.
-Dose and treatment guidelines follow the corresponding product sheet. Management of dosage and adverse effects specified in point H. 15 of the Protocol.
POPULATION in study and number TOTAL of subjects population under study: adult patients with diagnosis of NSCLC with predominantly squamous histology total number of subjects: the participation of approximately 51 patients is expected DISEASE OR DISORDER TO STUDY Non Small Cell Lung Cancer (NSCLC). MEDICATION DATA OBJECT OF STUDY The drug under study is erlotinib.
-Dose and treatment guidelines Follow the corresponding product sheet. Management of dosage and adverse effects specified in point H. 15 of the Protocol.
STUDY POPULATION AND NUMBER TOTAL OF SUBJECTS Study: adult patients with diagnosis of NSCLC with predominantly squamous histology total number of subjects: the participation of approximately 51 patients is expected.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 8 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with diagnosis of NSCLC with predominantly squamous histology. The subject shall be considered included in the study when, fulfilling the criteria of selection, accept their participation therein by the signing of informed consent.
Key inclusion criteria (5 listed)
- -• Age ≥ 18 years.
- Histological or cytologic diagnosis of cancer (NSCLC) with predominantly squamous histology stage IV non-small-cell lung.
- ECOG performance status between 0 and 2.
- Patients who have progressed to a first line of advanced disease and are eligible for a second line with Erlotinib.
- Patients that grant informed, preferably in writing, or oral consent before witnesses independent of the research team.
Key exclusion criteria (10 listed)
- -• Patients with uncontrolled or severe systemic disease, an active infection, neoplasia concomitant or secondary neoplasia to primary disease, except for carcinoma in situ of cervix or adequately treated skin carcinoma.
- Disease with mutated EGFR, according to local laboratory. The determination of the EGFR is not mandatory. Those patients from centers where there is the determination of the EGFR or those patients that the EGFR is unknown may be included in.
- Inability to take oral medication or previous surgical procedures that affect the absorption and imply the need for intravenous or parenteral feeding.
- Interstitial lung disease clinically active.
- Unstable angina or recent myocardial infarction.
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
Study the effectiveness of the administration of Erlotinib in 2nd line treatment in patients with advanced NSCLC scaly through assessment of the SLP
Time frame: Collect the available information of the visits made by the patient according to the usual practice up to a max of 9 m after the inclusion of the last patient.
1 secondary outcome
Determination TR y TCE. • Determinar SG. • Identificar los diferentes factores pronósticos relacionados con la SLP y SG. • Determinar el perfil de seguridad del tratamiento.
Time frame: Collect the available information of the visits made by the patient according to the usual practice up to a max of 9 m after the inclusion of the last patient.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 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.
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 Carcinoma, Squamous Cell, run by Grupo Gallego de Cancer de Pulmon at 1 site in Spain.
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 5 inclusion and 10 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 31 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Raquel Romero, Chemistry (+34982296459, raquel.romero.van.der.schoot@sergas.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study the effectiveness of the administration of Erlotinib in 2nd line treatment in patients with advanced NSCLC scaly through assessment of the SLP (time frame: Collect the available information of the visits made by the patient according to the usual practice up to a max of 9 m after the inclusion of the last patient.). 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 31 Dec 2014; AzTrials last refreshed its copy on 7 Nov 2026.