Non Small Cell Lung CancerNCT03872440
PDX Models From EGFR Mutant Tumors
An observational study of Non Small Cell Lung Cancer, run by Addario Lung Cancer Medical Institute at 1 site in United States.
Trial summary
A biospecimen collection study from individuals with EGFR mutant cancers resistant to EGFR TKIs or those harboring an Exon 20 insertion mutation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Nov 2018to 6 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- a. Male or female greater than 18 years of age at the time of consent or the age of majority in their residing state.
- 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.
- A clinically-indicated procedure (required by the patient's treating physician) scheduled no more than 30 calendar days from date of consent.
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- A minimum of 21 calendar days between the last dose of systemic therapy and the clinically-indicated procedure is strongly requested but not required*.
- 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*.
- 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.
Who cannot join
- a. Less than 18 years of age or age of majority for their residing state, at time of consent.
- 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.
- A biopsy or surgical procedure not scheduled for clinical/diagnostic purposes.
- Pleural effusion specimens collected outside of the US. e. A clinically-indicated procedure scheduled more than 30 calendar days from the date of consent.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Addario Lung Cancer Medical Institute
San Carlos, California, 94070
About this study
Official title: ALCMI-012 A Prospective Biospecimen Collection Study From Patients With EGFR Mutant Tumors
A biospecimen collection study from individuals with EGFR mutant cancers resistant to EGFR TKIs or those harboring an Exon 20 insertion mutation.
Read the 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.
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- EGFR mutant cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2019
- Study start14 Nov 2018
- Primary completion6 Jan 2020
- Study completion6 Jan 2020
Why it stopped: Did not meet the expected enrollment rate.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Addario Lung Cancer Medical Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03872440
- Sponsor's protocol ID
- ALCMI-012
- Status last verified
- Jan 2020
- First submitted
- 28 Jan 2019
- Last updated
- 9 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ALCMI-012 A Prospective Biospecimen Collection Study From Patients With EGFR Mutant Tumors
- ClinicalTrials.gov ID
- NCT03872440
- Acronym / sponsor ID
- ALCMI-012
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- EGFR mutant cancer
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Did not meet the expected enrollment rate.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Addario Lung Cancer Medical InstituteUniversity, hospital or other
- Study start
- 14 Nov 2018 (actual)
- Primary completion
- 6 Jan 2020 (actual)
- Study completion
- 6 Jan 2020 (actual)
- First posted
- 13 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (10 listed)
- a. Male or female greater than 18 years of age at the time of consent or the age of majority in their residing state.
- 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.
Key exclusion criteria (5 listed)
- a. Less than 18 years of age or age of majority for their residing state, at time of consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non Small Cell Lung Cancer, run by Addario Lung Cancer Medical Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2020.