NSCLCNCT02279004
A Prospective Study of Plasma Genotyping as a Noninvasive Biomarker for Genotype-directed Cancer Care
An observational study of NSCLC and Melanoma, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial summary
Tumor genotyping has become an essential biomarker for the care of advanced lung cancer and melanoma, and is currently used to identify patients for treatment with targeted kinase inhibitors like erlotinib and vemurafenib. Read more about this study
- Who is it for?
- Ages 18 years and older
- How many people
- 840 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jul 2014to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients with NSCLC and advanced melanoma that are either newly diagnosed, have acquired resistance to kinase inhibitor therapy or have a known targetable mutation and are beginning a new line of therapy.
Who may be able to join
- To participate in this study a participant must meet the eligibility of one of the following cohorts:
- Cohort 1: Cancers beginning initial treatment
- One of the following diagnoses:
- Cohort 1A (CLOSED):
- ---Advanced non-squamous NSCLC (including adenosquamous)
- Cohort 1B:
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- Stage II-III non-squamous NSCLC (including adenosquamous)
- Stage IIIB-IV melanoma
- Patient must be planned to begin initial therapy, or completely resected before or after receiving adjuvant therapy
- For patients with NSCLC, EGFR and KRAS genotype may be known or unknown
- For patients with melanoma, BRAF and NRAS genotype may be known or unknown
- For patients without tumor genotyping, there must be a plan for genotyping including either:
- Archived tumor tissue available and planned for genotyping
- A biopsy at some future time is anticipated and will be available for genotyping
- Cohort 2: Cancers with acquired resistance to targeted therapy
- One of the following diagnoses:
- Cohort 2A (CLOSED):
- ---Advanced NSCLC harboring a known EGFR mutation
- Cohort 2B:
- Advanced NSCLC harboring a targetable genotype other than EGFR
- Advanced melanoma harboring a known tumor genotype
- Clinical determination of progression targeted therapy, as evidence by plans to start a new systemic treatment regimen, or obtain a biopsy to plan a new treatment regimen
- New systemic treatment regimen planned OR
- Re-biopsy for resistance genotyping planned
- Note, date of targeted therapy start and clinical progression must be provided
- Cohort 3: Cancers with a known genotype starting palliative systemic therapy
- Cohort 3A (CLOSED):
- Advanced NSCLC harboring one of the following mutations:
- EGFR exon 19 deletion
- EGFR L858R
- EGFR T790M
- KRAS G12X
- BRAF V600E
- Patients must be initiating palliative systemic therapy, either on or off a clinical trial
- Cohort 4: Paired plasma NGS and ddPCR
- Cohort 4A (CLOSED):
- Advanced NSCLC, newly diagnosed or with progression following treatment.
- Biopsy tissue must be available or a biopsy planned and one of the following:
- Genotyping must have been performed previously
- Genotyping must be in progress
- A plan must exist to order genotyping on existing tissue or a planned re-biopsy
- Patient must not be eligible to enroll in cohort 1A or 2A due to:
- Not eligible for cohort 1A or 2A
- Eligible for cohort 1A or 2A but cohort has closed
- Cohort 4B: Undergenotyped NSCLC
- Advanced NSCLC, newly diagnosed or with progression following treatment.
- No known targetable genotype on prior tumor genotyping
- Biopsy planned for tumor genotyping
- Cohort 4C: EGFR-mutant NSCLC with acquired resistance
- Advanced EGFR-mutant NSCLC with progression on EGFR TKI
- Biopsy planned for resistance genotyping (e.g. T790M, etc)
- Cohort 5: Genotyped KRAS patients starting palliative systemic therapy
- Advanced NSCLC harboring a KRAS exon 2 mutation
- Patients must be initiating new systemic therapy, either on or off a clinical trial
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
About this study
Tumor genotyping has become an essential biomarker for the care of advanced lung cancer and melanoma, and is currently used to identify patients for treatment with targeted kinase inhibitors like erlotinib and vemurafenib. However, tumor genotyping can be slow and cumbersome, and is limited by availability of tumor biopsy tissue for testing. The aim of this study is to prospectively evaluate a blood-based genotyping tool that can quantify the presence of oncogenic mutations (EGFR, KRAS, BRAF) in patients with lung cancer and melanoma. This assay is being studied both as a diagnostic tool for classifying patient genotype, and a serial measurement tool for quantification of response and progression on therapy.
- Keywords
- Plasma Genotyping, NSCLC, Melanoma
- Medical subject headings
- Melanoma
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 |
|---|---|---|
| Newly Diagnosed Patients | Newly diagnosed patients with advanced NSCLC or melanoma with complete or planned tissue genotyping. | |
| Acquired Resistance Patients | NSCLC patients with a known EGFR mutation or other targetable mutation and acquired resistance to initial kinase inhibitor therapy. | |
| Known Genotype Patients | NSCLC patients with a known genomic alteration detectable by ddPCR-based plasma genotyping and planned to start a new line of therapy. | |
| Advanced NSCLC | Advanced NSCLC patients with a biopsy planned for tissue genotyping. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of Plasma Genotyping Assay
We will determine the accuracy of a droplet digital PCR (ddPCR)-based plasma genotyping assay in performing noninvasive tumor genotyping.
Measured: 2 years
Secondary outcomes (3)
Turnaround Time of Plasma Genotyping Assay
The amount of time required to perform this noninvasive genotyping assay.
Measured: 2 years
Early Treatment Failure
The ability of serial quantitative ddPCR-based plasma genotyping to predict early treatment failure in patients initiating a new line of therapy.
Measured: 2 years
Accuracy of Plasma NGS
We will determine the accuracy of plasma NGS in performing noninvasive genotyping compared to tumor NGS and paired ddPCR.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2014 (estimated)
- Study start3 Jul 2014
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- 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
- 840 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Damon Runyon Cancer Research Foundation
- Responsible party
- Principal investigator, Julia K. Rotow, MD, Dana-Farber Cancer Institute
- Investigators
- Julia Rotow, M.D., Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02279004
- Sponsor's protocol ID
- 14-147
- Status last verified
- Apr 2026
- First submitted
- 28 Oct 2014
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Plasma Genotyping as a Noninvasive Biomarker for Genotype-directed Cancer Care
- ClinicalTrials.gov ID
- NCT02279004
- Acronym / sponsor ID
- 14-147
- Keywords
- Plasma Genotyping, NSCLC, Melanoma
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 840 participants (estimated)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Damon Runyon Cancer Research Foundation
- Study start
- 3 Jul 2014 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 30 Oct 2014 (estimated)
- 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.
Tumor genotyping has become an essential biomarker for the care of advanced lung cancer and melanoma, and is currently used to identify patients for treatment with targeted kinase inhibitors like erlotinib and vemurafenib. However, tumor genotyping can be slow and cumbersome, and is limited by availability of tumor biopsy tissue for testing. The aim of this study is to prospectively evaluate a blood-based genotyping tool that can quantify the presence of oncogenic mutations (EGFR, KRAS, BRAF) in patients with lung cancer and melanoma. This assay is being studied both as a diagnostic tool for classifying patient genotype, and a serial measurement tool for quantification of response and progression on therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Newly Diagnosed Patients | – | –Newly diagnosed patients with advanced NSCLC or melanoma with complete or planned tissue genotyping. |
| Acquired Resistance Patients | – | –NSCLC patients with a known EGFR mutation or other targetable mutation and acquired resistance to initial kinase inhibitor therapy. |
| Known Genotype Patients | – | –NSCLC patients with a known genomic alteration detectable by ddPCR-based plasma genotyping and planned to start a new line of therapy. |
| Advanced NSCLC | – | –Advanced NSCLC patients with a biopsy planned for tissue genotyping. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with NSCLC and advanced melanoma that are either newly diagnosed, have acquired resistance to kinase inhibitor therapy or have a known targetable mutation and are beginning a new line of therapy.
Key inclusion criteria (54 listed)
- To participate in this study a participant must meet the eligibility of one of the following cohorts:
- Cohort 1: Cancers beginning initial treatment
- One of the following diagnoses:
- ---Advanced non-squamous NSCLC (including adenosquamous)
- Patient must be planned to begin initial therapy, or completely resected before or after receiving adjuvant therapy
Key exclusion criteria (3 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
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
Accuracy of Plasma Genotyping Assay
Time frame: 2 years
We will determine the accuracy of a droplet digital PCR (ddPCR)-based plasma genotyping assay in performing noninvasive tumor genotyping.
3 secondary outcomes
Turnaround Time of Plasma Genotyping Assay
Time frame: 2 years
Early Treatment Failure
Time frame: 2 years
Accuracy of Plasma NGS
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
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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.
Julia Rotow, M.D. 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 NSCLC and Melanoma, run by Dana-Farber Cancer 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 54 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: under way, not looking for participants, as of the sponsor's last update on 27 Apr 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?
This study is still under way. Results are not available in the source record yet.
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?
Accuracy of Plasma Genotyping Assay (time frame: 2 years). 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 27 Apr 2026.