ClinicalTrials.gg
Active, not recruitingNCT03289780INSIGHTUpdated Sep 19, 2025

Clinical Effectiveness Assessment of VeriStrat® Testing and Validation of Immunotherapy Tests in NSCLC Subjects

An observational study in Non-Small Cell Lung Cancer, sponsored by Biodesix, Inc.. Active, not recruiting at 42 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-19.

Sponsored by Biodesix, Inc. · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 11 months ago, but the record still lists the study as active, not recruiting.

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
5,006
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 3,366 studies in Carcinoma, Non-Small-Cell Lung with a site in United States — 518 open to participants now, 892 under way, 142 of them phase 3. Carcinoma, Non-Small-Cell Lung · United States.

Enrollment
11th of 246
5,006 · median 100
Started
2016
with 136 others
Observational
246 of 3,366
50 open now
Primary completion
2025-12
later than 154 of 890 live
Registered
1,923rd of 3,366
by date

Among the 3,366 studies in Carcinoma, Non-Small-Cell Lung with a site in United States, this one is the 11th largest by enrollment of the 246 observational ones that give a count, is one of 137 that started in 2016, is one of 246 observational ones, reaches primary completion later than 154 of the 890 other live ones, and was the 1,923rd registered.

Carcinoma, Non-Small-Cell Lung

7,624 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,837 are open to participants now.

Browse Carcinoma, Non-Small-Cell Lung studies →

Open to participants now

518 of the 3,366 studies in Carcinoma, Non-Small-Cell Lung with a site in United States are open now. Recruiting first, the newest first:

513 more — sign in →

All 518 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 1,326 Carcinoma, Non-Small-Cell Lung studies recruiting now, 988 (75%) set no upper age limit and 225 (17%) stop at 75 or younger; 34 take children under 18; 40 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 3,366 studies in Carcinoma, Non-Small-Cell Lung with a site in United States, or all of them as a file.
02

Study summary

The purpose of this study is to collect information about how a doctor uses the results of the VeriStrat® blood test to guide treatment for non-small cell lung cancer (NSCLC) patients. Understanding how VeriStrat test results influence doctors' decisions and patients' outcomes may help doctors to better treat NSCLC in the future. This study will also look to establish whether new investigational tests can help better predict the effectiveness of certain medications for certain patients. These new investigational tests are only for research purposes at this time.

Read the detailed description

The primary purpose of this observational study is to assess the physician's clinical practice patterns while using VeriStrat testing in subjects with NSCLC whose tumors are epidermal growth factor receptor (EGFR) wild-type (negative) or have unknown EGFR mutational status. This study will also attempt to further validate that VeriStrat test results stratify subjects by clinical outcomes in the real world, uncontrolled clinical setting while exploring whether certain therapeutic approaches may yield opportunities for further study.

Predictive tests that aid physician therapeutic decision making are critical for optimizing subject outcomes while minimizing toxicity and associated treatment costs. This study will provide data for the validation of immunotherapy tests currently being developed. Immunotherapy mechanisms are dependent upon the interactions between the tumor, tumor microenvironment, and the patient immune system. As such, a successful predictive test will reflect the complex interplay between tumor and host. The multivariate tests from Biodesix have the advantage of being able to assess this complex biology.

The information gained from this research will not only guide the adoption of the VeriStrat test and inform medical decision making, including treatment choice, but will allow the validation of additional mass-spectrometry-based proteomic tests.

03

Conditions studied

  • Non-Small Cell Lung Cancer
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Any Subject with Non-Small Cell Lung Cancer (NSCLC) at all stages with any histology.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Subject must be 18 years of age or older at time of signing form (ICF).
  2. A diagnosis of NSCLC.
  3. Subject is willing to provide serum samples for VeriStrat testing.
  4. EGFR mutation status wild-type (negative) or a tested unknown.
  5. For subjects with untested/unknown EGFR status only: The subject must be willing to provide blood samples for GeneStrat testing.
  6. Subject is willing to provide serum samples for research, understanding that no test results will be made available either to the subject or the treating physician.
  7. Subject is able to read and understand the ICF and agrees to comply with study procedures and requirements.

Exclusion criteria

Exclusion Criteria:

1. Subject's ability to understand the requirements of the protocol or to provide is impaired or subject is unwilling to comply with the protocol requirements.

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
5,006 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Physician Treatment Patterns Description

    Physician Treatment patterns Description: To describe physician treatment patterns pre and post-veriStrat testing. Describe the impact of the VeriStrat test results on treatment decisions, including but not limited to: percentage change in treatment decision, differences in chosen treatments between patients classified as VeriStrat good and those classified as VeriStrat Poor. Change in percentage of patients receiving systemic therapy or supportive therapies only.

    Time frame: 3 years

Secondary outcomes

  1. Immunotherapy Stratification by Overall Survival

    To determine whether immunotherapy test(s) stratify immunotherapy-treated subjects by overall survival.

    Time frame: 3 years

  2. Immunotherapy Stratification by Progression-Free Survival

    To determine whether immunotherapy test(s) stratify immunotherapy-treated subjects by progression-free survival.

    Time frame: 3 years

  3. VeriStrat Poor vs. Good Outcomes

    To compare progression free survival (PFS) and overall survival (OS) outcomes between those classified as VeriStrat-Poor and VeriStrat-Good.

    Time frame: 3 years

  4. Platinum-based therapy outcomes in VeriStrat Poor vs. Good subjects.

    To compare outcomes in subjects classified as VeriStrat-Poor and VeriStrat-Good and treated with platinum-based therapy.

    Time frame: 3 years

  5. Immunotherapy outcomes in VeriStrat Poor vs. Good subjects.

    To compare outcomes in subjects classified as VeriStrat-Poor and VeriStrat-Good and treated with immunotherapy.

    Time frame: 3 years

  6. Single agent chemotherapy outcomes in VeriStrat Poor vs. Good Subjects

    To compare outcomes in subjects classified as VeriStrat-Poor and VeriStrat-Good and treated with single agent chemotherapy.

    Time frame: 3 years

  7. VeriStrat label changes over time.

    To compare the longitudinal changes in VeriStrat classification over the course of the study

    Time frame: 3 years

Other outcomes

  1. Determination of Immunotherapy tests ability to stratify subjects based on treatment.

    To determine whether immunotherapy test(s) stratify subjects treated with chemotherapy or targeted therapies by outcome.

    Time frame: 3 years

  2. Correlation between the VeriStrat test and Immunotherapy tests.

    To observe the correlation between VeriStrat classification and immunotherapy test(s) classification at baseline and longitudinally.

    Time frame: 3 years

  3. Longitudinal changes in Immunotherapy tests.

    To describe the longitudinal changes in immunotherapy test classification over the course of the study.

    Time frame: 3 years

  4. Stratification of Immunotherapy Test(s)

    To determine whether immunotherapy test(s) stratify immunotherapy-treated subjects by other clinically meaningful factors or endpoints.

    Time frame: 3 years

  5. Changes in GeneStrat

    To observe changes in GeneStrat status across lines of therapy.

    Time frame: 3 years

07

Study locations

42 sites
08

References and documents

Publications

  • Akerley WL, Arnaud AM, Reddy B, Page RD. Impact of a multivariate serum-based proteomic test on physician treatment recommendations for advanced non-small-cell lung cancer. Curr Med Res Opin. 2017 Jun;33(6):1091-1097. doi: 10.1080/03007995.2017.1301903. Epub 2017 Mar 16. PubMed 28277859 ↗
  • Grossi F, Rijavec E, Genova C, Barletta G, Biello F, Maggioni C, Burrafato G, Sini C, Dal Bello MG, Meyer K, Roder J, Roder H, Grigorieva J. Serum proteomic test in advanced non-squamous non-small cell lung cancer treated in first line with standard chemotherapy. Br J Cancer. 2017 Jan 3;116(1):36-43. doi: 10.1038/bjc.2016.387. Epub 2016 Nov 29. PubMed 27898657 ↗
  • Rich P, Mitchell RB, Schaefer E, Walker PR, Dubay JW, Boyd J, Oubre D, Page R, Khalil M, Sinha S, Boniol S, Halawani H, Santos ES, Brenner W, Orsini JM, Pauli E, Goldberg J, Veatch A, Haut M, Ghabach B, Bidyasar S, Quejada M, Khan W, Huang K, Traylor L, Akerley W. Real-world performance of blood-based proteomic profiling in first-line immunotherapy treatment in advanced stage non-small cell lung cancer. J Immunother Cancer. 2021 Oct;9(10):e002989. doi: 10.1136/jitc-2021-002989. PubMed 34706885 ↗

Related links

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2016 (actual). Primary completion is estimated for Dec 2025, 116 months after the start.

Of 142 industry-sponsored observational studies under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 31 and three quarters within 64. This study's planned 116 months is above that.

Counting every sponsor, half of 498 studies reached it within 55 months; a quarter within 35 and three quarters within 83.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 16, 2017
First posted
Sep 21, 2017
StartActual
Apr 4, 2016
Primary completionEst.
Dec 2025
CompletionEst.
Dec 2025
Last update
Sep 19, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03289780
Lead sponsor
Biodesix, Inc.
Responsible party
Sponsor
First posted
Sep 21, 2017
Start date
Apr 4, 2016
Primary completion
Dec 2025 (estimated)
Completion
Dec 2025 (estimated)
Last update
Sep 19, 2025

Study contacts

Steve Springmeyer, MD
principal investigator · Biodesix, Inc.

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion