Status:
WITHDRAWN
PDX Models From EGFR Mutant Tumors
Lead Sponsor:
Addario Lung Cancer Medical Institute
Conditions:
Non Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Brief Summary
A biospecimen collection study from individuals with EGFR mutant cancers resistant to EGFR TKIs or those harboring an Exon 20 insertion mutation.
Detailed Description
EGFR mutations are detected in approximately 15% of all patients diagnosed with lung cancer. There are several types of EGFR mutations including both the common L858R and exon 19 deletions (accounting...
Eligibility Criteria
Inclusion
- a. Male or female greater than 18 years of age at the time of consent or the age of majority in their residing state.
- b. Confirmed diagnosis of EGFR mutant NSCLC.
- EGFR T790M patients who have progressed on osimertinib or other third generation (mutant selective) EGFR TKI therapy or
- Patients must have an EGFR exon 19 deletion or L858R and progressed on first line osimertinib or
- Patients with an exon EGFR or HER2 20 insertion mutation.
- c. A clinically-indicated procedure (required by the patient's treating physician) scheduled no more than 30 calendar days from date of consent.
- d. A minimum of 21 calendar days between the last dose of systemic therapy and the clinically-indicated procedure is strongly requested but not required\*.
- e. A minimum of 48 hours between the last dose of an osimertinib therapy or other targeted therapies and the time of the clinically-indicated procedure is strongly requested but not required\*.
- f. Willingness to undergo all study collection procedures and follow up. g. Provision of written informed consent by the patient. h. Able to communicate (read, write and speak) in English. i. Clinically-indicated procedure to be performed within the US (including Alaska, Hawaii and Puerto Rico), Canada, England, or Israel.
- \*A treatment washout period is considered best practice for building a PDX from a tumor specimen. However, if this is not medically possible, material may still be accepted to attempt to build a PDX. This may have a significant impact on take rate therefore accepting tumor specimens with no washout period can impact the overall expected take rate of the program.
Exclusion
- a. Less than 18 years of age or age of majority for their residing state, at time of consent.
- b. No confirmed diagnosis of EGFR exon 19 deletion, L858R or EGFR or HER2 exon 20 mutation. Patients whose tumors harbor EGFR mutations other than an exon 19 deletion, L858R or exon 20 EGFR insertion or HER2 exon 20 insertions are not eligible.
- c. A biopsy or surgical procedure not scheduled for clinical/diagnostic purposes.
- d. Pleural effusion specimens collected outside of the US. e. A clinically-indicated procedure scheduled more than 30 calendar days from the date of consent.
- f. Unwilling to undergo all study collection procedures and follow up. g. Unable or unwilling to provide consent. h. Unable to communicate in English. j. Clinically-indicated procedure not scheduled within the US, Canada, England, or Israel.
Key Trial Info
Start Date :
November 14 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 6 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03872440
Start Date
November 14 2018
End Date
January 6 2020
Last Update
January 9 2020
Active Locations (1)
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1
Addario Lung Cancer Medical Institute
San Carlos, California, United States, 94070