PDX Models From EGFR Mutant Tumors

NCT03872440 | Withdrawn

• 1 other identifier: ALCMI-012
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

A biospecimen collection study from individuals with EGFR mutant cancers resistant to EGFR TKIs or those harboring an Exon 20 insertion mutation.

Conditions

Non Small Cell Lung Cancer

Keywords

EGFR mutant cancer

Outcome Measures

Primary Outcomes (1)

• The primary objective is to develop a unique cohort of PDX models from EGFR mutant cancers as a resource to the research community.

  Successful generation of at least fifty (50) PDX models with full characterization including whole exome sequencing (WES) and RNA sequencing. These PDX models will be used to inform the study of EGFR-driven cancers at large.

  48 months

Study Arms (3)

EGFR T790M patients

EGFR T790M patients who have progressed on osimertinib or other third generation (mutant selective) EGFR TKI therapy

EGFR exon 19 del or L858R patients

EGFR exon 19 del or L858R patients who have progressed on first line osimertinib

Exon 20 insertion mutations patients

Patients with Exon 20 insertion mutations (n=10; regardless of drug therapy). Includes EGFR Exon 20 and up to two HER2 Exon20 patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Addario Lung Cancer Medical Institute: lead

Study Sites (1)

Addario Lung Cancer Medical Institute

San Carlos, California, 94070, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

The purpose of this study is the successful generation of at least ten (10), EGFR mutant PDX models with full characterization including whole exome sequencing (WES) and RNA sequencing. The models will be generated from three major cohorts: A.) EGFR T790M patients who have progressed on osimertinib or other third generation (mutant selective) EGFR TKI therapy (n=20) and B.) EGFR exon 19 del or L858R patients who have progressed on first line osimertinib (n=20) and C.) patients with Exon 20 insertion mutations (n=10; regardless of drug therapy). Includes EGFR Exon 20 and up to two HER2 Exon20 patients. The estimates take into consideration an overall take rate of 20%. Models can be used as a resource for clinical and translational research to understand mechanisms of resistance and develop new therapies. For cohort B there is no requirement for a specific number of patients with either EGFR exon 19 deletion or L858R mutations.

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2019
• First Posted: March 13, 2019
• Study Start: November 14, 2018
• Primary Completion: January 6, 2020
• Study Completion: January 6, 2020
• Last Updated: January 9, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)