Non-Small Cell Lung CancerSPACEWALKNCT03833934
Study of Plasma NGS for Assessment, Characterization, Evaluation of Patients With ALK Resistance
An observational study of Non-Small Cell Lung Cancer, run by Addario Lung Cancer Medical Institute at 1 site in United States.
Trial 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. 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
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jan 2019to 31 Oct 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: 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 larlatinib).
Who may be able to join
- Men or women older than 18 years at the time of consent.
- Demonstration of having advanced ALK positive NSCLC.
- Systemic progression (not CNS only progression) within the past 30 days while receiving a next generation ALK TKI.
- Patient must not have started a new line of therapy before signing the informed consent form.
- Willingness to provide a blood specimen prior to the initiation of a new line of treatment.
- Willing to provide clinical and medical information to the study team as required.
- Ability to read, write and communicate in English.
- Ability to sign a web-based informed consent form.
Who cannot join
- Participants who are unable to provide informed consent.
- Participants who are 18 years of age or younger.
- Participants who are unable to comply with the study procedures.
- Known existence of an uncontrolled intercurrent illness including, but not limited to, psychiatric illness or social situations that would impair compliance with study requirements.
- Participants who have previously enrolled to the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
About this study
Official title: ALCMI-011: Study of Plasma Next Generation Sequencing for Assessment, Characterization, Evaluation of Patients With ALK Resistance (SPACEWALK)
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 patient's 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.
Read more
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.
Read the 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 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 be sent to study participants, their physicians and study team within 1-2 weeks. 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 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 progresses on the participant's 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. Serial plasma NGS will also be assessed as a response biomarker. A total of 300 patients are planned to be enrolled, with the expectation that approximately 200 will have tumor-related mutations detected in plasma NGS.
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- ALK positive
- 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 |
|---|---|---|
| ALK-positive NSCLC with progression | Patients in this group signed consent, met eligibility criteria, and all had ALK-positive cancer of a primary lung lesion with systemic progression (excluding the central nervous system) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of ALK Fusion
To determine the prevalence of the ALK gene fusion in the cohort of patients with ALK-positive NSCLC with progression
Measured: 32 months
ALK Fusion Allelic Frequency
To determine the relative percentage of the ALK fusion within the cohort's gene pool
Measured: 32 months
Overall Prevalence of ALK Resistance Mechanism Among Patients With the ALK Fusion
To determine the overall prevalence of ALK resistance mechanism in patients with detectable ALK fusion in plasma as determined per plasma NGS
Measured: 32 months
Type of Resistance Mechanism: One or More Secondary ALK Kinase Domain Resistance Mutations
To determine the prevalence of the various types of ALK resistance mechanisms as measured by NGS
Measured: 32 months
Type of ALK Resistance Mechanism: Both ALK Resistance Mutations and Bypass Resistance
To determine the prevalence of the various types of ALK resistance mechanisms as measured by NGS
Measured: 32 months
Prevalance of ALK Restance Mechanism: Bypass Track Resistance
To determine the prevalence of the various types of ALK resistance mechanisms as measured by NGS
Measured: 32 months
Secondary outcomes (2)
Changed Treatment for NSCLC
Initiated a new ALK tyrosine kinase inhibitor for treatment of NSCLC following enrollment in the study
Measured: 32 months
Treatment Outcome: >50% Reduction of ALK Fusion Allelle Frequency
New ALK TKI treatment resulted in >50% reduction of ALK fusion allelle frequency
Measured: 32 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2019
- Study start23 Jan 2019
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Addario Lung Cancer Medical Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Dana-Farber Cancer Institute, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Geoffrey R Oxnard, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03833934
- Sponsor's protocol ID
- ALCMI-011
- Other IDs
- 5R21CA234816
- Acronym
- SPACEWALK
- Status last verified
- Sep 2025
- First submitted
- 28 Jan 2019
- Last updated
- 2 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lawrence MN, Tamen RM, Martinez P, Sable-Hunt A, Addario T, Barbour P, Shaffer T, Hosseini SA, Bertucci C, Lim LP, Hong F, Michael K, Simon GR, Riess JW, Awad MM, Oxnard GR. SPACEWALK: A Remote Participation Study of ALK Resistance Leveraging Plasma Cell-Free DNA Genotyping. JTO Clin Res Rep. 2021 Feb 3;2(4):100151. doi: 10.1016/j.jtocrr.2021.100151. eCollection 2021 Apr.
PubMed 34590008
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ALCMI-011: Study of Plasma Next Generation Sequencing for Assessment, Characterization, Evaluation of Patients With ALK Resistance (SPACEWALK)
- ClinicalTrials.gov ID
- NCT03833934
- Acronym / sponsor ID
- SPACEWALK / ALCMI-011
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- ALK positive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Addario Lung Cancer Medical InstituteUniversity, hospital or other
- Collaborators
- Dana-Farber Cancer Institute, National Cancer Institute (NCI)
- Study start
- 23 Jan 2019 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 7 Feb 2019 (actual)
- Results
- Posted 2 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 patient's 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 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 be sent to study participants, their physicians and study team within 1-2 weeks. 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 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 progresses on the participant's 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. Serial plasma NGS will also be assessed as a response biomarker. A total of 300 patients are planned to be enrolled, with the expectation that approximately 200 will have tumor-related mutations detected in plasma NGS.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ALK-positive NSCLC with progression | – | –Patients in this group signed consent, met eligibility criteria, and all had ALK-positive cancer of a primary lung lesion with systemic progression (excluding the central nervous system) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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 larlatinib).
Key inclusion criteria (8 listed)
- Men or women older than 18 years at the time of consent.
- Demonstration of having advanced ALK positive NSCLC.
- Systemic progression (not CNS only progression) within the past 30 days while receiving a next generation ALK TKI.
- Patient must not have started a new line of therapy before signing the informed consent form.
- Willingness to provide a blood specimen prior to the initiation of a new line of treatment.
Key exclusion criteria (5 listed)
- Participants who are unable to provide informed consent.
- Participants who are 18 years of age or younger.
- Participants who are unable to comply with the study procedures.
- Known existence of an uncontrolled intercurrent illness including, but not limited to, psychiatric illness or social situations that would impair compliance with study requirements.
- Participants who have previously enrolled to the study
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
Prevalence of ALK Fusion
Time frame: 32 months
To determine the prevalence of the ALK gene fusion in the cohort of patients with ALK-positive NSCLC with progression
ALK Fusion Allelic Frequency
Time frame: 32 months
To determine the relative percentage of the ALK fusion within the cohort's gene pool
Overall Prevalence of ALK Resistance Mechanism Among Patients With the ALK Fusion
Time frame: 32 months
To determine the overall prevalence of ALK resistance mechanism in patients with detectable ALK fusion in plasma as determined per plasma NGS
Type of Resistance Mechanism: One or More Secondary ALK Kinase Domain Resistance Mutations
Time frame: 32 months
To determine the prevalence of the various types of ALK resistance mechanisms as measured by NGS
Type of ALK Resistance Mechanism: Both ALK Resistance Mutations and Bypass Resistance
Time frame: 32 months
To determine the prevalence of the various types of ALK resistance mechanisms as measured by NGS
Prevalance of ALK Restance Mechanism: Bypass Track Resistance
Time frame: 32 months
To determine the prevalence of the various types of ALK resistance mechanisms as measured by NGS
2 secondary outcomes
Changed Treatment for NSCLC
Time frame: 32 months
Treatment Outcome: >50% Reduction of ALK Fusion Allelle Frequency
Time frame: 32 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 34590008Lawrence MN, Tamen RM, Martinez P, Sable-Hunt A, Addario T, Barbour P, Shaffer T, Hosseini SA, Bertucci C, Lim LP, Hong F, Michael K, Simon GR, Riess JW, Awad MM, Oxnard GR. SPACEWALK: A Remote Participation Study of ALK Resistance Leveraging Plasma Cell-Free DNA Genotyping. JTO Clin Res Rep. 2021 Feb 3;2(4):100151. doi: 10.1016/j.jtocrr.2021.100151. eCollection 2021 Apr.
- 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.
Geoffrey R Oxnard, MD principal investigator
Dana-Farber Cancer Institute
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 8 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: finished, as of the sponsor's last update on 2 Oct 2025. 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?
Yes. Results are posted in the registry (first posted 2 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Prevalence of ALK Fusion (time frame: 32 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03833934, which also lists 1 linked publication.
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 2 Oct 2025.