Ignite Creation Date:
2024-05-06 @ 12:45 PM
Last Modification Date:
2024-10-26 @ 1:03 PM
Study NCT ID:
NCT03833934
Status:
COMPLETED
Last Update Posted:
2024-07-03
First Post:
2019-01-28
Brief Title:
Study of Plasma NGS for Assessment Characterization Evaluation of Patients With ALK Resistance
Sponsor:
Addario Lung Cancer Medical Institute
Organization:
Addario Lung Cancer Medical Institute
Study Overview
Official Title:
ALCMI-011 Study of Plasma Next Generation Sequencing for Assessment Characterization Evaluation of Patients With ALK Resistance SPACEWALK
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPACEWALK
Brief Summary:
ALK-positive lung cancer is a subtype of lung cancer which carries a change in a gene called ALK anaplastic lymphoma kinase There are now many drugs for patients with ALK-positive lung cancer that slow cancer growth However after some time just as bacteria evolve resistance to antibiotics ALK-positive lung cancers evolve ways to avoid the therapies by developing new mutations so the drugs lost their effectiveness These new mutations can potentially be treated with a different drug For these new therapies the range of mutations that can develop at resistance is not well understood
It is now possible to detect the presence of mutations or changes in the genetic structure in lung cancer by analyzing a patients blood for bits of material shed by tumor This approach is often called a liquid biopsy Recently researchers have shown that looking at tumor molecules through liquid biopsies can provide doctors with some of the same information that tissue biopsies provide For example liquid biopsies can be used to detect mutations that cause drug resistance Obtaining liquid biopsies on patients with ALK-positive lung cancers at resistance to therapy may help better understand the different mutations that develop and guide therapy decisions
In this research study a blood specimen will be collected and submitted for liquid biopsy analysis at a commercial diagnostic company This company specializes in analyzing tumor material found in blood Specifically it will look for genetic changes in the ALK gene that could help understand why a cancer has developed drug resistance
This research study is for lung cancer patients with ALK-positive lung cancer who had been on a newer ALK targeted treatment such as ceritinib alectinib brigatinib or lorlatinib to determine whether they have developed ALK resistance mutations The investigators will collect a blood sample to examine these mutations Participants will not have to have a tissue biopsy to participate in this study Participants do not have to visit Dana-Farber Cancer Institute DFCI to participate All study procedures will be performed remotely
It is now possible to detect the presence of mutations or changes in the genetic structure in lung cancer by analyzing a patients blood for bits of material shed by tumor This approach is often called a liquid biopsy Recently researchers have shown that looking at tumor molecules through liquid biopsies can provide doctors with some of the same information that tissue biopsies provide For example liquid biopsies can be used to detect mutations that cause drug resistance Obtaining liquid biopsies on patients with ALK-positive lung cancers at resistance to therapy may help better understand the different mutations that develop and guide therapy decisions
In this research study a blood specimen will be collected and submitted for liquid biopsy analysis at a commercial diagnostic company This company specializes in analyzing tumor material found in blood Specifically it will look for genetic changes in the ALK gene that could help understand why a cancer has developed drug resistance
This research study is for lung cancer patients with ALK-positive lung cancer who had been on a newer ALK targeted treatment such as ceritinib alectinib brigatinib or lorlatinib to determine whether they have developed ALK resistance mutations The investigators will collect a blood sample to examine these mutations Participants will not have to have a tissue biopsy to participate in this study Participants do not have to visit Dana-Farber Cancer Institute DFCI to participate All study procedures will be performed remotely
Detailed Description:
SPACEWALK is an innovative remote consent and participation study using next-generation sequencing NGS of plasma cell-free DNA cfDNA to characterize resistance mechanisms arising in ALK-positive non-small cell lung cancer NSCLC after progression while on a next generation ALK tyrosine kinase inhibitor TKI Additionally the study will capture the potential of genomic-driven resistance therapy approach for effecting outcomes in patients with advanced ALK-positive NSCLC and TKI resistance Finally the study will assess the role of repeat plasma NGS in evaluating drug response
The study will accrue patients with advanced ALK-positive NSCLC on systemic progression outside the brain while on treatment with a next-generation ALK TKI Any patient interested in the study will find information about the study on the study website The patient will consent remotely through the study website and documentation of advanced ALK-positive NSCLC and systemic progression while on a next-generation ALK TKI The study team will then reach out to the patient to confirm eligibility and send a blood collection kit In the study kit the study participants will find all the necessary materials for local blood draws and collected specimens will be sent directly to the central study laboratory Resolution Bioscience for plasma NGS
Plasma NGS of cfDNA will involve sequencing of 19 genes including ALK permitting remote tumor genotyping Plasma NGS analysis and results will be done following standard procedures of the Resolution Bioscience CLIA-certified laboratory Results will take 1-2 weeks to be sent back to study participants their physicians and study team Those plasma NGS reports will not include any specific treatment recommendations but will describe the presence of an ALK rearrangement ALK resistance mutation or other relevant mutations
Study participants are then followed remotely The study coordinator will contact the participants weekly for 4 weeks after enrolled into the study to learn of any new treatment initiation and to release an additional plasma collection kit 2-4 weeks after starting treatment Study participants will then be remotely contacted every 3 months to follow clinical outcomes on therapy for up to 2 years If the cancer begins to grow again on the participants new treatment the patient will have the option to provide a third blood specimen Medical records and local imaging will be collected and studied
The primary objective of the study is to characterize ALK TKI resistance to next-generation ALK TKIs in patients with advanced ALK-positive NSCLC Secondarily the investigators will assess the potential of plasma NGS to impact outcome on treatment by studying time to treatment discontinuation TTD Serial plasma NGS will also be assessed as a response biomarker A total of 300 patients will be enrolled with the expectation that approximately 200 will have tumor-related mutations detected in plasma NGS
The study will accrue patients with advanced ALK-positive NSCLC on systemic progression outside the brain while on treatment with a next-generation ALK TKI Any patient interested in the study will find information about the study on the study website The patient will consent remotely through the study website and documentation of advanced ALK-positive NSCLC and systemic progression while on a next-generation ALK TKI The study team will then reach out to the patient to confirm eligibility and send a blood collection kit In the study kit the study participants will find all the necessary materials for local blood draws and collected specimens will be sent directly to the central study laboratory Resolution Bioscience for plasma NGS
Plasma NGS of cfDNA will involve sequencing of 19 genes including ALK permitting remote tumor genotyping Plasma NGS analysis and results will be done following standard procedures of the Resolution Bioscience CLIA-certified laboratory Results will take 1-2 weeks to be sent back to study participants their physicians and study team Those plasma NGS reports will not include any specific treatment recommendations but will describe the presence of an ALK rearrangement ALK resistance mutation or other relevant mutations
Study participants are then followed remotely The study coordinator will contact the participants weekly for 4 weeks after enrolled into the study to learn of any new treatment initiation and to release an additional plasma collection kit 2-4 weeks after starting treatment Study participants will then be remotely contacted every 3 months to follow clinical outcomes on therapy for up to 2 years If the cancer begins to grow again on the participants new treatment the patient will have the option to provide a third blood specimen Medical records and local imaging will be collected and studied
The primary objective of the study is to characterize ALK TKI resistance to next-generation ALK TKIs in patients with advanced ALK-positive NSCLC Secondarily the investigators will assess the potential of plasma NGS to impact outcome on treatment by studying time to treatment discontinuation TTD Serial plasma NGS will also be assessed as a response biomarker A total of 300 patients will be enrolled with the expectation that approximately 200 will have tumor-related mutations detected in plasma NGS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None