Liquid Biopsy NGS Prompt for Lung Cancer

(iNUDGE Trial)

Recruiting at 6 trial locations

Overseen By Anthony Martella, MBMI

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Charu Aggarwal

Disqualifiers: Incomplete staging, Children, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

360 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a digital "nudge" called iNUDGE to encourage doctors to order molecular tests for advanced lung cancer patients. The goal is to have test results ready before treatment begins, enabling doctors to select the best treatment based on the cancer's specific characteristics. The trial also evaluates how well this nudge system performs in real-world settings. Suitable candidates have recently been diagnosed with metastatic non-squamous non-small cell lung cancer and have not yet started treatment. Participants must receive care at specified Penn Medicine locations. As an unphased trial, this study offers patients the chance to contribute to innovative research that could enhance cancer care practices.

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 prior data suggests that this protocol is safe?

Research has shown that iNUDGE is an electronic tool that reminds doctors to order important tests for patients with advanced lung cancer. As it is not a drug or physical treatment, there are no direct safety concerns for participants. Instead, it ensures doctors have all the necessary information before starting treatments. Consequently, there are no reports of side effects or negative events linked to iNUDGE itself. This trial focuses on using the tool effectively and does not involve testing a new drug or medical procedure. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Liquid Biopsy NGS Prompt for Lung Cancer trial because it explores a novel method, iNUDGE, for early cancer detection. Unlike traditional biopsies, which are invasive and time-consuming, liquid biopsies offer a non-invasive alternative by analyzing cancer-related materials in the blood. The iNUDGE system aims to enhance the timing and accuracy of these analyses, potentially leading to earlier and more precise detection of lung cancer. This could revolutionize lung cancer management by allowing for quicker intervention and personalized treatment strategies.

What evidence suggests that the iNUDGE protocol is effective for improving molecular testing in lung cancer?

Research has shown that the iNUDGE system, implemented in this trial, can remind doctors to order crucial tests for patients with advanced lung cancer. This is vital because less than half of these patients typically receive the necessary tests. Studies have found that when doctors receive reminders through electronic health records, more patients undergo these tests. These tests enable doctors to select the best treatment based on each patient's specific cancer type. In short, iNUDGE aims to make test results more accessible, leading to more personalized and effective treatments. ^{1 2 5 6 7}

Who Is on the Research Team?

Charu Aggarwal, MD, MPH

Principal Investigator

Penn Medicine

Are You a Good Fit for This Trial?

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

Participants with incomplete staging information.

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• iNUDGE

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.

How Is the Trial Designed?

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.

Who Is Running the Clinical Trial?

Charu Aggarwal

Lead Sponsor

Trials

1

Recruited

360+

Eli Lilly and Company

Industry Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Loxo Oncology, Inc.

Industry Sponsor

Trials

72

Recruited

11,600+

Jacob Van Naarden

Loxo Oncology, Inc.

Chief Executive Officer since 2019

A.B. in Molecular Biology from Princeton University

Dr. Jennifer Low

Loxo Oncology, Inc.

Chief Medical Officer since 2014

MD and PhD from Georgetown University; Undergraduate degree from California Institute of Technology

Published Research Related to This Trial

Targeted next generation sequencing (NGS) of liquid biopsies in advanced non-small cell lung cancer (NSCLC) showed a positive percent agreement (PPA) for detecting mutations, with the highest rate of 67.8% for EGFR, indicating that while liquid biopsies can identify some mutations, they may not fully replace tissue biopsies.

Liquid biopsies can be a useful tool for therapeutic decision-making in NSCLC, but they currently do not detect all clinically relevant mutations as effectively as tissue biopsies, highlighting the need for further research to establish their role in clinical practice.

NCBI (Pubmed)

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. Esagian, SM., Grigoriadou, GΙ., Nikas, IP., et al.[2021]

In a study of 24 advanced non-small cell lung cancer (NSCLC) patients, liquid biopsies revealed potential resistance mechanisms in 57% of those progressing on targeted therapies, highlighting the importance of genetic analysis in treatment planning.

The most common resistance mechanisms identified were mutations in ALK and EGFR, found in 38% of patients, indicating that monitoring these genetic changes can inform oncologists about the effectiveness of ongoing treatments.

NCBI (Pubmed)

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. Mayo de Las Casas, C., Garzón-Ibañez, M., Jordana-Ariza, N., et al.[2022]

Next-generation sequencing (NGS) combined with liquid biopsy represents a significant advancement in the precision medicine approach for non-small cell lung cancer (NSCLC), allowing for comprehensive genomic profiling in a minimally invasive way.

This method not only helps identify actionable genomic alterations but also enables dynamic monitoring of tumor evolution and treatment responses, highlighting its potential for improving diagnosis and treatment strategies in NSCLC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The emerging roles of NGS-based liquid biopsy in non-small cell lung cancer. Zhang, YC., Zhou, Q., Wu, YL.[2023]

Liquid biopsies, which analyze circulating tumor DNA (ctDNA), provide a non-invasive way to gather comprehensive tumor information, making them a promising tool for monitoring lung cancer and identifying genetic alterations.

These blood-based tests can detect genetic changes before they are visible through traditional imaging, allowing for earlier intervention and personalized treatment adjustments based on the tumor's genetic profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liquid biopsies in lung cancer-time to implement research technologies in routine care? Köhn, L., Johansson, M., Grankvist, K., et al.[2020]

The SiRe next-generation sequencing (NGS) panel effectively identified somatic mutations in lung cancer tissue samples, with only 8.7% of specimens failing to produce usable data, demonstrating its reliability in clinical settings.

In a small group of 11 patients treated based on SiRe results, 82% showed a partial response to treatment, with a median progression-free survival of 340 days, indicating promising efficacy for guiding therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance analysis of SiRe next-generation sequencing panel in diagnostic setting: focus on NSCLC routine samples. Pepe, F., De Luca, C., Smeraglio, R., et al.[2018]

Next-generation sequencing (NGS) from plasma samples in treatment-naïve patients with non-squamous cell lung carcinoma (NSCC) is feasible and shows good correlation with tissue-based testing, indicating its potential utility in clinical practice.

However, in this study of 24 patients, the impact of liquid biopsy on therapy selection was limited, and it could not replace traditional tissue testing for guiding treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective evaluation of NGS-based liquid biopsy in untreated late stage non-squamous lung carcinoma in a single institution. Heeke, S., Hofman, V., Ilié, M., et al.[2021]

Liquid biopsy has transformed cancer management by effectively identifying actionable cancer markers, especially when traditional tissue biopsies are not possible.

Next generation sequencing applied to liquid biopsy enhances tumor genotyping and monitoring, making it a powerful tool for early detection and understanding resistance mechanisms in lung cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The evolving role of liquid biopsy in lung cancer. Malapelle, U., Pisapia, P., Pepe, F., et al.[2022]

The study identified hypermethylation of the CFTR gene in the plasma of non-small-cell lung carcinoma (NSCLC) patients, indicating it could serve as a potential blood-based biomarker for diagnosing NSCLC.

The CFTR promoter showed a sensitivity of 52% and a specificity of 90% in distinguishing NSCLC patients from those without malignancy, suggesting it has promising diagnostic potential that warrants further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Liquid biopsy in human non-small-cell lung cancer : Blood-based analysis of ctDNA methylation]. Schulz, H., Tator, M., Spillner, J., et al.[2020]

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.TPS8664

iNUDGE: Integration of liquid biopsy based next generation ... The primary objective of this trial is to test the effectiveness of a BE informed EHR nudge intervention to increase availability of comprehensive molecular ...

2. pc3i.upenn.edu pc3i.upenn.edu/our-work/projects/inudge/

iNUDGE: Integration of Liquid Biopsy Based Next Generation ... iNUDGE uses electronic health records to “nudge” care providers to order molecular testing for patients newly diagnosed with non small-cell lung cancer.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05853887

Liquid Biopsy Based NGS in Newly Diagnosed NSCLC This study expands the application of an electronic health record (EHR) "nudge" used to prompt physicians' clinical practice to order molecular testing at ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38959441/

Electronic Medical Record-Based Nudge Intervention to ... Purpose: Less than half of the patients with newly diagnosed metastatic non-small cell lung cancer (NSCLC) undergo comprehensive molecular testing. We designed ...

5. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/87/NCT05853887/Prot_SAP_000.pdf

Liquid biopsy based NGS in newly diagnosed NSCLC Biomarker testing and tissue journey among patients with metastatic non-small cell lung cancer receiving first-line therapy in The US Oncology.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11781134/

Remote symptom monitoring with patient-reported outcomes ... This study proposes an electronic PRO-based symptom tracking intervention, integrated with reactive alerts and nudges (PRO-NET) to improve HRQoL for advanced ...

7. ascopubs.org ascopubs.org/doi/abs/10.1200/OP.24.00070?md5=9e15a4e684e34dc337778b51649f0493&cid=DM17739&bid=394289309

Electronic Medical Record–Based Nudge Intervention to ... Less than half of the patients with newly diagnosed metastatic non–small cell lung cancer (NSCLC) undergo comprehensive molecular testing.