Liquid Biopsy NGS Prompt for Lung Cancer

(iNUDGE Trial)

Recruiting in Palo Alto (17 mi)

+5 other locations

Overseen by Charu Aggarwal, MD, MPH

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Charu Aggarwal

Disqualifiers: Incomplete staging, Children, Pregnant, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This study expands the application of an electronic health record (EHR) "nudge" used to prompt physicians' clinical practice to order molecular testing at the time of initial diagnosis for patients with specific types of advanced lung cancer. The primary goal is to have these test results available prior to starting treatment so that physicians can make molecularly-informed treatment decisions. The second goal is to better understand factors that contribute to whether or not the EHR-nudge implementation is successful.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment iNUDGE for lung cancer?

The research highlights that using liquid biopsy with next-generation sequencing (NGS) can help identify important genetic changes in lung cancer, which can guide treatment decisions. This method is especially useful when traditional tissue samples are hard to obtain, suggesting that iNUDGE, if it uses similar technology, could be effective in managing lung cancer. ^{1 2 3 4 5}

Is liquid biopsy NGS safe for humans?

The research does not specifically address safety concerns for liquid biopsy NGS in humans, but it is generally used as a non-invasive alternative to traditional tissue biopsies, which suggests it is considered safe for use in clinical settings. ^{1 2 3 6 7}

How is the Liquid Biopsy NGS treatment different from other treatments for lung cancer?

The Liquid Biopsy NGS treatment is unique because it uses a blood test to analyze cancer DNA, making it less invasive than traditional tissue biopsies. This method can provide a comprehensive view of the cancer's genetic makeup, helping to identify specific targets for treatment and monitor changes over time. ^{1 2 3 5 8}

Eligibility Criteria

This trial is for adults with a specific lung cancer type called metastatic non-squamous NSCLC, who haven't started treatment. They must be diagnosed at certain Penn Medicine locations. Pregnant women, children, and prisoners are excluded.

Inclusion Criteria

I have a type of lung cancer called non-squamous NSCLC and haven't been treated for it since it spread.

Participants must be seen at Lancaster General Health (LGH), Penn Presbyterian Medical Center (PPMC), Penn Medicine Cherry Hill (PMCH), Penn Medicine Princeton Health (PMPH), Penn Medicine Voorhees (PMV) or Penn Medicine Washington Township (PMWT) for mNSq NSCLC.

Exclusion Criteria

Children, pregnant women, fetuses, neonates, or prisoners are not included in this research study.

Participants with incomplete staging information.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Implementation of EHR-based nudge intervention for molecular testing at initial diagnosis

6 weeks

Regular intervals for cluster randomization

Follow-up

Participants are monitored for the effectiveness of the EHR nudge intervention and molecularly informed treatment initiation

3 months

Evaluation

Semi-structured interviews to evaluate contextual mechanisms and health equity factors

Post-trial period

Treatment Details

Interventions

• iNUDGE (Behavioral)

Trial Overview The study tests an 'EHR-nudge' prompting doctors to order molecular testing when diagnosing advanced lung cancer. The aim is to use test results for informed treatment decisions and understand the nudge's effectiveness.

Participant Groups

Group I: Penn Presbyterian Medical Center Experimental Treatment 1 Intervention

All sites with be randomized to implement the nudge at different points in time. Prospective data with be compared with each site's respective baseline numbers over a two-year period.

Group II: Penn Medicine New Jersey Experimental Treatment 1 Intervention

All sites with be randomized to implement the nudge at different points in time. Prospective data with be compared with each site's respective baseline numbers over a two-year period.

Group III: Penn Medicine Lancaster General Health Experimental Treatment 1 Intervention

All sites with be randomized to implement the nudge at different points in time. Prospective data with be compared with each site's respective baseline numbers over a two-year period.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Penn Presbyterian Medical Center Philadelphia, PA

Penn Medicine Princeton Health Plainsboro, NJ

Penn Medicine Washington Township Sewell, NJ

Penn Medicine Voorhees Voorhees, NJ

More Trial Locations

Who Is Running the Clinical Trial?

Charu Aggarwal Lead Sponsor

Loxo Oncology, Inc. Industry Sponsor

References

1. Germany pubmed.ncbi.nlm.nih.gov

Comparison of liquid-based to tissue-based biopsy analysis by targeted next generation sequencing in advanced non-small cell lung cancer: a comprehensive systematic review. [2021] To explore whether targeted next generation sequencing (NGS) of liquid biopsy in advanced non-small cell lung cancer (NSCLC) could potentially overcome the innate problems that arise with standard tissue biopsy, like intratumoral heterogeneity and the inability to obtain adequate samples for analysis.

2. Ireland pubmed.ncbi.nlm.nih.gov

The evolving role of liquid biopsy in lung cancer. [2022] Liquid biopsy has revolutionized the management of cancer patients. In particular, liquid biopsy-based testing has proven to be highly beneficial for identifying actionable cancer markers, especially when solid tissue biopsies are insufficient or unattainable. Beyond the predictive role, liquid biopsy may be a useful tool for comprehensive tumor genotyping, identification of emergent resistance mechanisms, monitoring of minimal residual disease, early detection, and cancer interception. The application of next generation sequencing to liquid biopsy has led to the "quantum leap" of predictive molecular pathology. Here, we review the evolving role of liquid biopsy in lung cancer.

3. England pubmed.ncbi.nlm.nih.gov

Prospective evaluation of NGS-based liquid biopsy in untreated late stage non-squamous lung carcinoma in a single institution. [2021] NGS from plasma samples in non-squamous cell lung carcinoma (NSCC) can aid in the detection of actionable genomic alterations. However, the absolute clinical value of NGS in liquid biopsy (LB) made at baseline is currently uncertain. We assessed the impact of plasma-based NGS using an in-house test and an outsourced test in comparison to a routine molecular pathology workflow.

4. China pubmed.ncbi.nlm.nih.gov

Prospective analysis of liquid biopsies of advanced non-small cell lung cancer patients after progression to targeted therapies using GeneReader NGS platform. [2022] In a significant percentage of advanced non-small cell lung cancer (NSCLC) patients, tumor tissue is unavailable or insufficient for genetic analyses at time to progression. We prospectively analyzed the appearance of genetic alterations associated with resistance in liquid biopsies of advanced NSCLC patients progressing to targeted therapies using the NGS platform.

5. England pubmed.ncbi.nlm.nih.gov

The emerging roles of NGS-based liquid biopsy in non-small cell lung cancer. [2023] The treatment paradigm of non-small cell lung cancer (NSCLC) has evolved into oncogene-directed precision medicine. Identifying actionable genomic alterations is the initial step towards precision medicine. An important scientific progress in molecular profiling of NSCLC over the past decade is the shift from the traditional piecemeal fashion to massively parallel sequencing with the use of next-generation sequencing (NGS). Another technical advance is the development of liquid biopsy with great potential in providing a dynamic and comprehensive genomic profiling of NSCLC in a minimally invasive manner. The integration of NGS with liquid biopsy has been demonstrated to play emerging roles in genomic profiling of NSCLC by increasing evidences. This review summarized the potential applications of NGS-based liquid biopsy in the diagnosis and treatment of NSCLC including identifying actionable genomic alterations, tracking spatiotemporal tumor evolution, dynamically monitoring response and resistance to targeted therapies, and diagnostic value in early-stage NSCLC, and discussed emerging challenges to overcome in order to facilitate clinical translation in future.

6. China pubmed.ncbi.nlm.nih.gov

Liquid biopsies in lung cancer-time to implement research technologies in routine care? [2020] Lung cancer is the leading cause of cancer mortality. A substantial progress in the understanding of lung cancer biology has resulted in several promising targeted therapies for advanced disease. Druggable targets today include point mutations such as EGFR, BRAF and re-arrangements in genes such as ALK and ROS1. Liquid biopsies collecting e.g., circulating tumor DNA (ctDNA) reflects overall tumor information and is not biased by analyzing of only a small fraction of the tumor and is always accessible in contrast to the lung cancer tissue. Technological advances in detection of low frequency mutation variants in ctDNA have made it the dominating liquid biopsy platform in terms of utility and sensitivity. Circulating DNA or RNA may possible be used to define populations with higher risk of developing lung cancer, thus reducing screening cohorts and increasing the positive predictive value of screening. Blood based-tests may also aid to identify genetic alterations several weeks prior to radiologically verified recurrence and may be of great value in the follow-up of lung cancer patients. Besides being an alternative to invasive biopsies in selected cases, liquid biopsies offer a unique possibility to monitor treatment response following medical treatment as well as treatment response and resistance development after targeted therapy, giving a possibility to modify the treatment after the genetic profile of the tumor. Ideally, genetic alterations found in ctDNA could be tracked in real-time discriminating between fast-growing life-threatening tumors from more indolent slow growing tumors or premalignant growth that are of no concern for the wellbeing of the patient. This review focuses on future perspectives of liquid biopsies in lung cancer care for different clinical settings and present current technological platforms for further discussion of possible strategies for implementation of liquid biopsies in lung cancer.

7. England pubmed.ncbi.nlm.nih.gov

Performance analysis of SiRe next-generation sequencing panel in diagnostic setting: focus on NSCLC routine samples. [2018] Label="AIMS" NlmCategory="OBJECTIVE">Following the development for liquid biopsies of the SiRe next-generation sequencing (NGS) panel that covers 568 clinical relevant mutations in EGFR, KRAS, NRAS, BRAF, cKIT and PDGFRa genes, in this current study, we apply this small NGS panel on tissue samples of lung cancer.

8. Germany pubmed.ncbi.nlm.nih.gov

[Liquid biopsy in human non-small-cell lung cancer : Blood-based analysis of ctDNA methylation]. [2020] Use of liquid biopsy for minimal invasive follow-up diagnostics of non-small-cell lung carcinomas (NSCLCs).