Clinical trial NCT03872440: PDX Models From EGFR Mutant Tumors
Official title: ALCMI-012 A Prospective Biospecimen Collection Study From Patients With EGFR Mutant Tumors
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Non Small Cell Lung Cancer
Keywords: EGFR mutant cancer
Lead sponsor: Addario Lung Cancer Medical Institute
Sponsor class: OTHER
First posted: 2019-03-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of fifty (50) implantations from approximately fifty (50) subjects, meeting all of the inclusion and none of the exclusion criteria to establish a minimum of ten (10) PDX models.

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 for 85%) or the rare exon 20 insertion (accounting for 5-8%) EGFR mutations.

Different types of therapies are being used for these two groups of EGFR mutations. Osimertinib is an EGFR inhibitor approved for patients newly diagnosed with EGFR exon 19 or L858R mutations and for patients who have been treated with a prior EGFR inhibitor but have developed EGFR T790M as a resistance mechanism. In contrast, there are no approved EGFR inhibitors for patients with EGFR or HER2 exon 20 insertion mutations although several therapies are under evaluation in clinical trials.

The Addario Lung Cancer Medical Institute (ALCMI) would like to focus on studying the cancers of patients previously treated with osimertinib or those with EGFR or HER2 exon 20 insertion mutations. The goal is to better understand how these tumors respond to drugs, and what happens when tumors stop responding to drugs. By studying these cancers ALCMI hopes to accelerate the development of new therapeutic approaches for patients with EGFR mutant lung cancer.

Eligibility criteria: Inclusion Criteria:

* 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.
  1. EGFR T790M patients who have progressed on osimertinib or other third generation (mutant selective) EGFR TKI therapy or
  2. Patients must have an EGFR exon 19 deletion or L858R and progressed on first line osimertinib or
  3. 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 Criteria:

* 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.

Primary outcomes:
measure: The primary objective is to develop a unique cohort of PDX models from EGFR mutant cancers as a resource to the research community.
timeFrame: 48 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Carlos
country: United States
facility: Addario Lung Cancer Medical Institute
state: California
Study officials:
References: