Liquid Biopsy Based NGS in Newly Diagnosed NSCLC

NCT05853887 | Active Not Recruiting

• 2 other identifiers: UPCC 27522852795
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Non Small Cell Lung Cancer Metastatic; Newly Diagnosed NSCLC; Non-Squamous Non-Small Cell Neoplasm of Lung

Keywords

Next Generation Sequencing; Liquid biopsy; Newly diagnosed; Molecular testing; Plasma based next generation sequencing; Electronic health record; Nudge intervention; Targeted therapy; Behavioral economics

Outcome Measures

Primary Outcomes (1)

• Availability of comprehensive molecular test results prior to first line therapy for patients with newly diagnosed mNSq NSCLC

  Were comprehensive molecular test results available prior to initiation of 1L therapy? (Yes/No)

  Measured up to 6 weeks from initial diagnosis

Secondary Outcomes (7)

• Successful EHR based nudge delivery

  Measured up to 6 weeks from randomization

• Turnaround time of delivery of provider focused alerts

  Measured up to 6 weeks from randomization

• Completion of comprehensive molecular testing & modality used

  Measured up to 3 months from initial diagnosis

• Reasons for failure to complete comprehensive molecular testing:

  Measured up to 3 months from initial diagnosis

• Time to molecularly informed treatment initiation

  Measured up to 6 weeks from initial diagnosis

Study Arms (3)

Penn Medicine New Jersey

OTHER

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.

Behavioral: iNUDGE

Penn Medicine Lancaster General Health

OTHER

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.

Behavioral: iNUDGE

Penn Presbyterian Medical Center

OTHER

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.

Behavioral: iNUDGE

Interventions

iNUDGE BEHAVIORAL

Electronic health record nudge which prompts physicians to order plasma-based NGS testing for eligible patients with newly diagnosed lung cancer.

Penn Medicine Lancaster General Health; Penn Medicine New Jersey; Penn Presbyterian Medical Center

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants with a histological, or cytological diagnosis of metastatic non-squamous (mNSq) non-small cell lung cancer (NSCLC) who have not yet received systemic treatment for metastatic disease.
• 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.

You may not qualify if:

• Participants with incomplete staging information.
• Children, pregnant women, fetuses, neonates, or prisoners are not included in this research study.

Sponsors & Collaborators

• Charu Aggarwal: lead
• Eli Lilly and Company: collaborator

Study Sites (6)

Penn Medicine Cherry Hill

Cherry Hill, New Jersey, 08003, United States

Location

Penn Medicine Princeton Health

Plainsboro, New Jersey, 08536, United States

Location

Penn Medicine Washington Township

Sewell, New Jersey, 08080, United States

Location

Penn Medicine Voorhees

Voorhees Township, New Jersey, 08043, United States

Location

Penn Medicine Lancaster General Health

Lancaster, Pennsylvania, 17602, United States

Location

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (11)

• Aggarwal C, Rolfo CD, Oxnard GR, Gray JE, Sholl LM, Gandara DR. Strategies for the successful implementation of plasma-based NSCLC genotyping in clinical practice. Nat Rev Clin Oncol. 2021 Jan;18(1):56-62. doi: 10.1038/s41571-020-0423-x. Epub 2020 Sep 11.

  PMID: 32918064 BACKGROUND

• Rolfo C, Mack P, Scagliotti GV, Aggarwal C, Arcila ME, Barlesi F, Bivona T, Diehn M, Dive C, Dziadziuszko R, Leighl N, Malapelle U, Mok T, Peled N, Raez LE, Sequist L, Sholl L, Swanton C, Abbosh C, Tan D, Wakelee H, Wistuba I, Bunn R, Freeman-Daily J, Wynes M, Belani C, Mitsudomi T, Gandara D. Liquid Biopsy for Advanced NSCLC: A Consensus Statement From the International Association for the Study of Lung Cancer. J Thorac Oncol. 2021 Oct;16(10):1647-1662. doi: 10.1016/j.jtho.2021.06.017. Epub 2021 Jul 8.

  PMID: 34246791 BACKGROUND

• Singal G, Miller PG, Agarwala V, Li G, Kaushik G, Backenroth D, Gossai A, Frampton GM, Torres AZ, Lehnert EM, Bourque D, O'Connell C, Bowser B, Caron T, Baydur E, Seidl-Rathkopf K, Ivanov I, Alpha-Cobb G, Guria A, He J, Frank S, Nunnally AC, Bailey M, Jaskiw A, Feuchtbaum D, Nussbaum N, Abernethy AP, Miller VA. Association of Patient Characteristics and Tumor Genomics With Clinical Outcomes Among Patients With Non-Small Cell Lung Cancer Using a Clinicogenomic Database. JAMA. 2019 Apr 9;321(14):1391-1399. doi: 10.1001/jama.2019.3241.

  PMID: 30964529 BACKGROUND

• Robert NJ, Espirito JL, Chen L, Nwokeji E, Karhade M, Evangelist M, Spira A, Neubauer M, Bullock S, Walberg J, Cheng SK, Coleman RL. Biomarker testing and tissue journey among patients with metastatic non-small cell lung cancer receiving first-line therapy in The US Oncology Network. Lung Cancer. 2022 Apr;166:197-204. doi: 10.1016/j.lungcan.2022.03.004. Epub 2022 Mar 10.

  PMID: 35313244 BACKGROUND

• Thompson JC, Yee SS, Troxel AB, Savitch SL, Fan R, Balli D, Lieberman DB, Morrissette JD, Evans TL, Bauml J, Aggarwal C, Kosteva JA, Alley E, Ciunci C, Cohen RB, Bagley S, Stonehouse-Lee S, Sherry VE, Gilbert E, Langer C, Vachani A, Carpenter EL. Detection of Therapeutically Targetable Driver and Resistance Mutations in Lung Cancer Patients by Next-Generation Sequencing of Cell-Free Circulating Tumor DNA. Clin Cancer Res. 2016 Dec 1;22(23):5772-5782. doi: 10.1158/1078-0432.CCR-16-1231. Epub 2016 Sep 6.

  PMID: 27601595 BACKGROUND

• Leighl NB, Page RD, Raymond VM, Daniel DB, Divers SG, Reckamp KL, Villalona-Calero MA, Dix D, Odegaard JI, Lanman RB, Papadimitrakopoulou VA. Clinical Utility of Comprehensive Cell-free DNA Analysis to Identify Genomic Biomarkers in Patients with Newly Diagnosed Metastatic Non-small Cell Lung Cancer. Clin Cancer Res. 2019 Aug 1;25(15):4691-4700. doi: 10.1158/1078-0432.CCR-19-0624. Epub 2019 Apr 15.

  PMID: 30988079 BACKGROUND

• Aggarwal C, Thompson JC, Black TA, Katz SI, Fan R, Yee SS, Chien AL, Evans TL, Bauml JM, Alley EW, Ciunci CA, Berman AT, Cohen RB, Lieberman DB, Majmundar KS, Savitch SL, Morrissette JJD, Hwang WT, Elenitoba-Johnson KSJ, Langer CJ, Carpenter EL. Clinical Implications of Plasma-Based Genotyping With the Delivery of Personalized Therapy in Metastatic Non-Small Cell Lung Cancer. JAMA Oncol. 2019 Feb 1;5(2):173-180. doi: 10.1001/jamaoncol.2018.4305.

  PMID: 30325992 BACKGROUND

• Shelton RC, Chambers DA, Glasgow RE. An Extension of RE-AIM to Enhance Sustainability: Addressing Dynamic Context and Promoting Health Equity Over Time. Front Public Health. 2020 May 12;8:134. doi: 10.3389/fpubh.2020.00134. eCollection 2020.

  PMID: 32478025 BACKGROUND

• Rendle KA, Abramson CM, Garrett SB, Halley MC, Dohan D. Beyond exploratory: a tailored framework for designing and assessing qualitative health research. BMJ Open. 2019 Aug 27;9(8):e030123. doi: 10.1136/bmjopen-2019-030123.

  PMID: 31462482 BACKGROUND

• Kane H, Lewis MA, Williams PA, Kahwati LC. Using qualitative comparative analysis to understand and quantify translation and implementation. Transl Behav Med. 2014 Jun;4(2):201-8. doi: 10.1007/s13142-014-0251-6.

  PMID: 24904704 BACKGROUND

• Whitaker RG, Sperber N, Baumgartner M, Thiem A, Cragun D, Damschroder L, Miech EJ, Slade A, Birken S. Coincidence analysis: a new method for causal inference in implementation science. Implement Sci. 2020 Dec 11;15(1):108. doi: 10.1186/s13012-020-01070-3.

  PMID: 33308250 BACKGROUND

Study Officials

• Charu Aggarwal, MD, MPH

  Penn Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This intervention is directed towards physicians. Individuals will not be randomized.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Leslye M. Heisler Associate Professor of Lung Cancer Excellence and Associate Director, Penn Center for Precision Medicine

Model Details: This study employs a stepped-wedge cluster randomized clinical trial design. Randomization will occur at the group (site) level. Sites will be turned on according to the stepped-wedge cluster randomized design but will run in parallel.

Study Record Dates

• First Submitted: April 7, 2023
• First Posted: May 11, 2023
• Study Start: June 15, 2023
• Primary Completion: February 27, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)