Status:
COMPLETED
T790M Mutation Testing in Blood by Different Methodologies
Lead Sponsor:
Spanish Lung Cancer Group
Conditions:
NSCLC Stage IV
Eligibility:
All Genders
Brief Summary
Three laboratories will participate in the study. Each laboratory will analyze the same samples by different methodologies according to the flow indicated in figure 1. This design will allow comparing...
Detailed Description
Three blood samples per patient will be collected once at the time of progression, assessed by CT Scans according to RECIST criteria v.1.1 and before the patients start a new treatment The blood sampl...
Eligibility Criteria
Inclusion
- Patients diagnosed with EGFR mutant, stage IIIB and IV non small cell lung cancer and who have progressed assessed by CT Scans according to RECIST criteria v.1.1 to first or second generation EGFR tyrosine kinase inhibitors (TKIs) (e.g. gefitinib, erlotinib, afatinib) including patients who received a chemotherapy line before TKI treatment. Samples have to be drawn before the patient starts a new treatment,
- Patients have to sign the informed consent of the study
- Patients aged ≥ 18 years.
Exclusion
- Patients progressing to third generation EGFR TKIs (e.g. Osimertinib (TKI))
- No possibility of venipuncture.
Key Trial Info
Start Date :
March 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 30 2019
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT03363139
Start Date
March 1 2018
End Date
March 30 2019
Last Update
April 8 2020
Active Locations (30)
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1
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, A Coruña, Spain, 15706
2
Hospital Virgen de los Lirios
Alcoy, Alicante, Spain, 03804
3
Hospital General Universitario de Elche
Elche, Alicante, Spain, 03203
4
Complejo Hospitalario Universitario Insular de Gran Canaria
Las Palmas de Gran Canaria, Gran Canaria, Spain, 35016