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STUDY OBSERVATIONAL OF ERLOTINIB AS SECOND LINE TREATMENT IN PATIENTS WITH SQUAMOUS NSCLC AND EGFR NATIVE (GGCP 055/12)

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ClinicalTrials.gov Identifier: NCT02328391
Recruitment Status : Unknown
Verified September 2014 by Grupo Gallego de Cancer de Pulmon.
Recruitment status was:  Recruiting
First Posted : December 31, 2014
Last Update Posted : December 31, 2014
Sponsor:
Information provided by (Responsible Party):
Grupo Gallego de Cancer de Pulmon

Brief 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).

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.


Condition or disease
Carcinoma, Squamous Cell

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 51 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 8 Months
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
Study Start Date : September 2013
Estimated Primary Completion Date : March 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  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. [ 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. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

-• 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.

Exclusion Criteria:

-• 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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02328391


Contacts
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Contact: Raquel Romero, Chemistry +34982296459 raquel.romero.van.der.schoot@sergas.es

Locations
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Spain
Grupo Gallego Cancer de Pulmon Recruiting
Santiago de Compostela, A Coruña, Spain
Contact: Raquel Romero, Chemestry    +34982296459    raquel.romero.van.der.schoot@sergas.es   
Principal Investigator: Sergio Vázquez Estévez, Oncologist         
Principal Investigator: José Luis Fírvida, Oncologist         
Principal Investigator: Martín Lázaro Quintela, Oncologist         
Principal Investigator: Joaquín Casal Rubio, Oncologist         
Principal Investigator: Lucia Santomé, Oncologist         
Principal Investigator: Margarita Amenedo, Oncologist         
Sponsors and Collaborators
Grupo Gallego de Cancer de Pulmon
Additional Information:

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Responsible Party: Grupo Gallego de Cancer de Pulmon
ClinicalTrials.gov Identifier: NCT02328391    
Other Study ID Numbers: GGC-ERL-2012-01
First Posted: December 31, 2014    Key Record Dates
Last Update Posted: December 31, 2014
Last Verified: September 2014
Additional relevant MeSH terms:
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Carcinoma, Squamous Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell