Clinical trial · Observational
Studying Pathways of Resistance in KRAS-driven Cancers
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| KRAS P.G12C | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FoundationOne® Liquid CDx | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Cohort 1A
- description
- Patients who are currently progressing on a KRAS G12C inhibitor. Plasma for ctDNA analysis will be collected.
- interventionNames
- Diagnostic Test: FoundationOne® Liquid CDx
- label
- Cohort 1B
- description
- 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.
- interventionNames
- Diagnostic Test: FoundationOne® Liquid CDx
Primary outcomes (1)
- measure
- Genomic mechanisms of acquired resistance to KRAS inhibitors
- timeFrame
- up to 24 months follow-up
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Cohort 1A- Liquid Biopsy 1. Participants older than 18 years old at the time of consent or age of majority for residential state. 2. Demonstration of having advanced KRAS G12C positive cancer. 3. Systemic progression (not CNS only progression) within the past 30 days, having previously been treated with a therapeutic, targeting the specific KRAS mutation. 4. Patient must not have started a new line of therapy before signing the informed consent form. 5. Willingness to provide a blood specimen prior to the initiation of a new line of treatment. 6. Willingness to provide clinical and medical information to the study team as required. 7. Ability to read, write and communicate in English. 8. Ability to sign a web-based informed consent form. Cohort 1B- Data Sharing 1. Participants older than 18 years old at the time of consent or age of majority for residential state. 2. Demonstration of having advanced KRAS G12C positive cancer. 3. Systemic progression (not CNS only progression) after being treated with a therapeutic targeting the specific KRAS mutation. 4. Patient must have prior tumor genotyping available (tissue or plasma) after progression on therapeutic targeting the specific KRAS mutation. 5. Willingness to provide clinical and medical information to the study team as required. 6. Ability to read, write and communicate in English. 7. Ability of the participant or legally authorized representative (LAR) to sign a web-based informed consent form. Exclusion Criteria: 1. Participants who are unable to comply with the study procedures. 2. Known existence of an uncontrolled intercurrent illness including, but not limited to, psychiatric illness or social situations that would impair compliance with study requirements. 3. Participants who have previously enrolled to the study.
References
Publications (0)
Data not yet available