KRAS P.G12CSPARKNCT05272423
Studying Pathways of Resistance in KRAS-driven Cancers
An observational study of KRAS P.G12C, run by Addario Lung Cancer Medical Institute at 1 site in United States.
Trial summary
Up to 250 patients from anywhere in the United States can remotely consent and participate to have plasma drawn locally and submitted to Foundation Medicine, Inc. (FMI), for the FoundationOne® Liquid Biopsy Assay. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- KRAS P.G12C
- What is being tested?
- FoundationOne® Liquid CDx
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2022to 6 Apr 2026
- 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: Adult subjects with a diagnosis of acquired resistance to KRAS inhibitors
Who may be able to join
- Cohort 1A- Liquid Biopsy
- Participants older than 18 years old at the time of consent or age of majority for residential state.
- Demonstration of having advanced KRAS G12C positive cancer.
- Systemic progression (not CNS only progression) within the past 30 days, having previously been treated with a therapeutic, targeting the specific KRAS mutation.
- 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.
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- Willingness 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.
- Cohort 1B- Data Sharing
- Participants older than 18 years old at the time of consent or age of majority for residential state.
- Demonstration of having advanced KRAS G12C positive cancer.
- Systemic progression (not CNS only progression) after being treated with a therapeutic targeting the specific KRAS mutation.
- Patient must have prior tumor genotyping available (tissue or plasma) after progression on therapeutic targeting the specific KRAS mutation.
- Willingness to provide clinical and medical information to the study team as required.
- Ability to read, write and communicate in English.
- Ability of the participant or legally authorized representative (LAR) to sign a web-based informed consent form.
Who cannot join
- 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: A Non-interventional, Non-treatment, Non-randomized, Single Coordinating Center, Decentralized Bio-specimen Collection Study in USA-based Adult Subjects With Acquired Resistance to KRAS Inhibitors
Up to 250 patients from anywhere in the United States can remotely consent and participate to have plasma drawn locally and submitted to Foundation Medicine, Inc. (FMI), for the FoundationOne® Liquid Biopsy Assay. Patients who have had resistance mechanisms determined through other assays can also consent to share these data. The Investigator(s) will compare mechanisms of acquired resistance across drugs (e.g. sotorasib vs adagrasib) and between tumor types (e.g. NSCLC vs CRC) to determine if different resistance mutations arise in these settings.
Read the detailed description
A hypothesis is that a remote participation plasma NGS study will characterize resistance mechanisms arising in KRAS-mutant cancers among individuals experiencing disease progression while on a KRAS-targeting therapy, and that subsequent therapies may be further personalized based on the results of plasma NGS testing.
After a web-based remote consent is obtained, subjects will be sent blood collection kits with the necessary materials for local draws and those specimens will be sent to the Dana-Farber Cancer Institute (DFCI), and rerouted to the central laboratory (Foundation Medicine, Inc.) for plasma NGS and to the ALCMI for storage. Plasma NGS results will be returned to the participant's treating physician, and the study team, aiming to be returned within approximately 2 weeks. In addition, subsequent treatments and clinical outcomes will be prospectively monitored. A correlation between the resistance mechanisms and clinical outcomes will be analyzed.
Patients with KRAS G12C mutant cancers will be enrolled in two cohorts.
- Cohort 1A will enroll patients who are currently progressing on a KRAS G12C inhibitor and plasma for ctDNA analysis will be collected from these patients remotely.
- Cohort 1B will enroll patients who have already had a sequencing assay performed to determine the resistance mechanism to a KRAS G12C inhibitor. These patients will be invited to share their data and medical history with the study team. Plasma for ctDNA analysis will be optional for this cohort.
- Conditions
- KRAS P.G12C
- Being tested
- FoundationOne® Liquid CDx
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FoundationOne® Liquid CDxDiagnostic test
The FoundationOne® Liquid CDx is an FDA-approved companion diagnostic that analyzes guideline-recommended genes from a simple blood draw.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1A | Patients who are currently progressing on a KRAS G12C inhibitor. Plasma for ctDNA analysis will be collected. Receives: Diagnostic Test: FoundationOne® Liquid CDx | |
| Cohort 1B | Patients who have already had a sequencing assay performed to determine the resistance mechanism to a KRAS G12C inhibitor. These patients will be invited to share their data and medical history. Plasma for ctDNA analysis will be optional. Receives: Diagnostic Test: FoundationOne® Liquid CDx |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genomic mechanisms of acquired resistance to KRAS inhibitors
The Investigator(s) will summarize mechanisms of acquired resistance with descriptive statistics (percentage and confidence interval), and compare across drugs (e.g., sotorasib vs adagrasib) and between tumor types (e.g., NSCLC vs CRC) to determine if different resistance mutations arise in these settings, using Fisher's exact test.
Measured: up to 24 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2022
- Study start8 Sep 2022
- Primary completion10 Dec 2025
- Study completion6 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KRAS P.G12CStudies 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
- 58 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
- NCT05272423
- Sponsor's protocol ID
- ALCMI-016
- Acronym
- SPARK
- Status last verified
- Aug 2026
- First submitted
- 1 Mar 2022
- Last updated
- 4 Aug 2026
- 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 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-interventional, Non-treatment, Non-randomized, Single Coordinating Center, Decentralized Bio-specimen Collection Study in USA-based Adult Subjects With Acquired Resistance to KRAS Inhibitors
- ClinicalTrials.gov ID
- NCT05272423
- Acronym / sponsor ID
- SPARK / ALCMI-016
- Conditions
- KRAS P.G12C
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Addario Lung Cancer Medical InstituteUniversity, hospital or other
- Study start
- 8 Sep 2022 (actual)
- Primary completion
- 10 Dec 2025 (actual)
- Study completion
- 6 Apr 2026 (actual)
- First posted
- 9 Mar 2022 (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.
Up to 250 patients from anywhere in the United States can remotely consent and participate to have plasma drawn locally and submitted to Foundation Medicine, Inc. (FMI), for the FoundationOne® Liquid Biopsy Assay. Patients who have had resistance mechanisms determined through other assays can also consent to share these data. The Investigator(s) will compare mechanisms of acquired resistance across drugs (e.g. sotorasib vs adagrasib) and between tumor types (e.g. NSCLC vs CRC) to determine if different resistance mutations arise in these settings.
Detailed description
A hypothesis is that a remote participation plasma NGS study will characterize resistance mechanisms arising in KRAS-mutant cancers among individuals experiencing disease progression while on a KRAS-targeting therapy, and that subsequent therapies may be further personalized based on the results of plasma NGS testing.
After a web-based remote consent is obtained, subjects will be sent blood collection kits with the necessary materials for local draws and those specimens will be sent to the Dana-Farber Cancer Institute (DFCI), and rerouted to the central laboratory (Foundation Medicine, Inc.) for plasma NGS and to the ALCMI for storage. Plasma NGS results will be returned to the participant's treating physician, and the study team, aiming to be returned within approximately 2 weeks. In addition, subsequent treatments and clinical outcomes will be prospectively monitored. A correlation between the resistance mechanisms and clinical outcomes will be analyzed.
Patients with KRAS G12C mutant cancers will be enrolled in two cohorts.
- Cohort 1A will enroll patients who are currently progressing on a KRAS G12C inhibitor and plasma for ctDNA analysis will be collected from these patients remotely.
- Cohort 1B will enroll patients who have already had a sequencing assay performed to determine the resistance mechanism to a KRAS G12C inhibitor. These patients will be invited to share their data and medical history with the study team. Plasma for ctDNA analysis will be optional for this cohort.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1A | – | Diagnostic Test: FoundationOne® Liquid CDxPatients who are currently progressing on a KRAS G12C inhibitor. Plasma for ctDNA analysis will be collected. |
| Cohort 1B | – | Diagnostic Test: FoundationOne® Liquid CDxPatients who have already had a sequencing assay performed to determine the resistance mechanism to a KRAS G12C inhibitor. These patients will be invited to share their data and medical history. Plasma for ctDNA analysis will be optional. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult subjects with a diagnosis of acquired resistance to KRAS inhibitors
Key inclusion criteria (17 listed)
- Cohort 1A- Liquid Biopsy
- Cohort 1B- Data Sharing
- Participants older than 18 years old at the time of consent or age of majority for residential state.
- Demonstration of having advanced KRAS G12C positive cancer.
- Systemic progression (not CNS only progression) after being treated with a therapeutic targeting the specific KRAS mutation.
Key exclusion criteria (3 listed)
- 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FoundationOne® Liquid CDxThe FoundationOne® Liquid CDx is an FDA-approved companion diagnostic that analyzes guideline-recommended genes from a simple blood draw. | Diagnostic test | Cohort 1A, Cohort 1B |
Primary outcome
Genomic mechanisms of acquired resistance to KRAS inhibitors
Time frame: up to 24 months follow-up
The Investigator(s) will summarize mechanisms of acquired resistance with descriptive statistics (percentage and confidence interval), and compare across drugs (e.g., sotorasib vs adagrasib) and between tumor types (e.g., NSCLC vs CRC) to determine if different resistance mutations arise in these settings, using Fisher's exact test.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- SPARK study webpageLink provided by the sponsor.
- 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 KRAS P.G12C, 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 17 inclusion and 3 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 4 Aug 2026. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Genomic mechanisms of acquired resistance to KRAS inhibitors (time frame: up to 24 months follow-up). 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 4 Aug 2026.