PDX Models From EGFR Mutant Tumors
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|ClinicalTrials.gov Identifier: NCT03872440|
Recruitment Status : Recruiting
First Posted : March 13, 2019
Last Update Posted : March 13, 2019
|Condition or disease|
|Non Small Cell Lung Cancer|
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.
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||ALCMI-012 A Prospective Biospecimen Collection Study From Patients With EGFR Mutant Tumors|
|Actual Study Start Date :||November 14, 2018|
|Estimated Primary Completion Date :||November 2022|
|Estimated Study Completion Date :||November 2022|
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
- The primary objective is to develop a unique cohort of PDX models from EGFR mutant cancers as a resource to the research community. [ Time Frame: 48 months ]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.
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.
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): NCT03872440
|Contact: Alicia Sable-Hunt, RN, MBA, CCRAfirstname.lastname@example.org|
|Contact: Richard Erwinemail@example.com|
|United States, California|
|Addario Lung Cancer Medical Institute||Recruiting|
|San Carlos, California, United States, 94070|
|Contact: Alicia L Sable-Hunt, RN 888-403-3437 firstname.lastname@example.org|
|Principal Investigator: Pasi A Janne, MD, PhD|