Non Small Cell Lung Cancer MetastaticiNUDGENCT05853887
Liquid Biopsy Based NGS in Newly Diagnosed NSCLC
A study testing iNUDGE in people with Non Small Cell Lung Cancer Metastatic and Newly Diagnosed NSCLC, run by Charu Aggarwal at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Non Small Cell Lung Cancer Metastatic, Newly Diagnosed NSCLC, Non-Squamous Non-Small Cell Neoplasm of Lung
- What is being tested?
- iNUDGE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 6 sitesUnited States
- Study dates
- 15 Jun 2023to 31 Dec 2026
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Participants with incomplete staging information.
- Children, pregnant women, fetuses, neonates, or prisoners are not included in this research study.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Penn Medicine Cherry Hill
Cherry Hill, New Jersey, 08003
Penn Medicine Lancaster General Health
Lancaster, Pennsylvania, 17602
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
Penn Medicine Princeton Health
Plainsboro, New Jersey, 08536
Penn Medicine Washington Township
Sewell, New Jersey, 08080
Penn Medicine Voorhees
Voorhees Township, New Jersey, 08043
About this study
Official title: iNUDGE: INtegration of liqUiD Biopsy Based Next Generation Gene sEquencing in Newly Diagnosed NSCLC - A Stepped Wedge Cluster Randomized Clinical 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.
Read the detailed description
At the University of Pennsylvania Health System (UPHS), a behavioral economics (BE) informed "nudge" strategy was piloted to guide physicians' clinical practice to include concurrent use of plasma and tissue-based next generation sequencing (NGS) testing at the time of initial diagnosis for patients with newly diagnosed metastatic non-squamous (mNSq) non-small cell lung cancer (NSCLC). These findings have demonstrated that behavioral, electronic health record (EHR)-based nudges are feasible and can promote guideline concordant diagnostic testing at both community and academic sites.
The overarching goal of this current trial is to expand the application of the BE informed nudges, which includes a Best Practice Advisory (BPA) and Electronic Decision Support Tool (e-CDS) approach, which has been operationalized within Epic, the EHR used at UPHS, to six satellite hospitals. Our central hypothesis is that this approach will dramatically increase adoption of comprehensive molecular testing and enhance the delivery of molecularly informed 1L therapy in patients with newly diagnosed mNSq NSCLC.
Intervention: A multicomponent BE-informed EHR-based nudge designed to facilitate comprehensive molecular testing by embedding a default P-NGS order into the EHR at the time of the NPV. If ordered, test results are incorporated into provider workflows and conveyed through electronic clinical decision support (e-CDS) notifications. This support program will notify clinicians of targetable mutations, potential clinical trials, as well as absence of mutations detected on plasma testing as a means of improving the timely delivery of molecularly informed therapy.
Study Design
Objective 1: In a stepped wedge cluster randomized trial of newly diagnosed patients with mNSq NSCLC, evaluate the effectiveness of a multicomponent BE-informed EHR-based nudge intervention at increasing timely receipt of comprehensive molecular test results prior to 1L therapy by incorporating P-NGS into the standard clinical workup.
The design of this trial will include 3 clusters, representing 6 community hospitals. There will be an initial period in which no clusters are exposed to the intervention. Subsequently, at regular intervals (the "steps") one cluster (or a group of clusters) will be randomized to cross from the control to the intervention under evaluation. This process will continue until all clusters have crossed over to be exposed to the intervention. At the end of the study there will be a period when all clusters are exposed. Data collection will continue throughout the study, so that each cluster will contribute observations under both control and intervention observation periods. Two years of baseline data will be obtained from all study sites for comparison.
Objective 2: Assess the contextual mechanisms influencing the adoption, reach, and effectiveness of EHR-based nudge interventions, with a lens for health equity in molecular testing using mixed-methods.
Using rigorous approaches proven successful in our prior work, we will recruit patient and clinician participants from each site to complete semi-structured interviews and structured questionnaires. The goal of this objective is to understand contextual mechanisms (e.g., patient, clinician, clinic, structural factors) shaping adoption, reach, and effectiveness of each intervention and identify how response may differ by key characteristics. These data will be analyzed using convergent mixed methods analysis, which employs the simultaneous collection and analysis of both quantitative and qualitative data to gain a comprehensive understanding of the multi-level factors shaping trial outcomes.
- Conditions
- Non Small Cell Lung Cancer Metastatic, Newly Diagnosed NSCLC, Non-Squamous Non-Small Cell Neoplasm of Lung
- Being tested
- iNUDGE
- Keywords
- Next Generation Sequencing, Liquid biopsy, Newly diagnosed, Molecular testing, Plasma based next generation sequencing, Electronic health record, Nudge intervention, Targeted therapy, Behavioral economics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iNUDGEBehavioural
Electronic health record nudge which prompts physicians to order plasma-based NGS testing for eligible patients with newly diagnosed lung cancer.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: iNUDGE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured up to 6 weeks from initial diagnosis
Secondary outcomes (7)
Successful EHR based nudge delivery
Amongst eligible patients, calculate the proportion of patients for whom the EHR nudge fired successfully (Yes/No). Applicable for the patients enrolled in the time periods following randomization.
Measured: Measured up to 6 weeks from randomization
Turnaround time of delivery of provider focused alerts
Reported as number of days, median. Applicable for the patients enrolled in the time periods following randomization.
Measured: Measured up to 6 weeks from randomization
Completion of comprehensive molecular testing & modality used
Relative and absolute change in completion of comprehensive testing by tissue and plasma, plasma alone, or tissue alone will be tabulated.
Measured: Measured up to 3 months from initial diagnosis
Reasons for failure to complete comprehensive molecular testing:
Summarize reasons for failure of completion of testing i. Tissue related (QNS) ii. Patient related factors (unable to biopsy, patient declined biopsy etc.) iii. Assay related factors (plasma assay does not detect mutations) iv. Other
Measured: Measured up to 3 months from initial diagnosis
Time to molecularly informed treatment initiation
- Calculated as time to therapy from the date of diagnosis of Stage IV disease (date of biopsy) ii. Calculated as time to therapy from the date of first new patient visit with medical oncology
Measured: Measured up to 6 weeks from initial diagnosis
Type of therapy received
- Targeted therapy ii. Chemo-immunotherapy iii. Immunotherapy iv. Clinical trial or n v. None
Measured: Measured up to 3 months from initial diagnosis
Overall survival
- Time from initial diagnosis to date of death or last follow up. ii. 1 year and 2-year overall survival rates will be calculated for the intervention group, and compared to baseline.
Measured: Measured up to 1 year from the time of randomization to death from any cause
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start15 Jun 2023
- Primary completion27 Feb 2026
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Non Small Cell Lung Cancer MetastaticStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charu Aggarwal
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Responsible party
- Sponsor-investigator, Charu Aggarwal, Abramson Cancer Center at Penn Medicine
- Investigators
- Charu Aggarwal, MD, MPH, Principal investigator, Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05853887
- Sponsor's protocol ID
- UPCC 27522
- Other IDs
- 852795
- Acronym
- iNUDGE
- Status last verified
- Mar 2026
- First submitted
- 7 Apr 2023
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: A Clinical Study Report will be made available to the study sponsor.
Publications
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.
PubMed 32918064Rolfo 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.
PubMed 34246791Singal 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.
PubMed 30964529Robert 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.
PubMed 35313244Thompson 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.
PubMed 27601595Leighl 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.
PubMed 30988079Aggarwal 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.
PubMed 30325992Shelton 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.
PubMed 32478025Rendle 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.
PubMed 31462482Kane 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.
PubMed 24904704Whitaker 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.
PubMed 33308250
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- iNUDGE: INtegration of liqUiD Biopsy Based Next Generation Gene sEquencing in Newly Diagnosed NSCLC - A Stepped Wedge Cluster Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05853887
- Acronym / sponsor ID
- iNUDGE / UPCC 27522
- 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
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Charu AggarwalUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 27 Feb 2026 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 11 May 2023 (actual)
- 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.
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.
Detailed description
At the University of Pennsylvania Health System (UPHS), a behavioral economics (BE) informed "nudge" strategy was piloted to guide physicians' clinical practice to include concurrent use of plasma and tissue-based next generation sequencing (NGS) testing at the time of initial diagnosis for patients with newly diagnosed metastatic non-squamous (mNSq) non-small cell lung cancer (NSCLC). These findings have demonstrated that behavioral, electronic health record (EHR)-based nudges are feasible and can promote guideline concordant diagnostic testing at both community and academic sites.
The overarching goal of this current trial is to expand the application of the BE informed nudges, which includes a Best Practice Advisory (BPA) and Electronic Decision Support Tool (e-CDS) approach, which has been operationalized within Epic, the EHR used at UPHS, to six satellite hospitals. Our central hypothesis is that this approach will dramatically increase adoption of comprehensive molecular testing and enhance the delivery of molecularly informed 1L therapy in patients with newly diagnosed mNSq NSCLC.
Intervention: A multicomponent BE-informed EHR-based nudge designed to facilitate comprehensive molecular testing by embedding a default P-NGS order into the EHR at the time of the NPV. If ordered, test results are incorporated into provider workflows and conveyed through electronic clinical decision support (e-CDS) notifications. This support program will notify clinicians of targetable mutations, potential clinical trials, as well as absence of mutations detected on plasma testing as a means of improving the timely delivery of molecularly informed therapy.
Study Design
Objective 1: In a stepped wedge cluster randomized trial of newly diagnosed patients with mNSq NSCLC, evaluate the effectiveness of a multicomponent BE-informed EHR-based nudge intervention at increasing timely receipt of comprehensive molecular test results prior to 1L therapy by incorporating P-NGS into the standard clinical workup.
The design of this trial will include 3 clusters, representing 6 community hospitals. There will be an initial period in which no clusters are exposed to the intervention. Subsequently, at regular intervals (the "steps") one cluster (or a group of clusters) will be randomized to cross from the control to the intervention under evaluation. This process will continue until all clusters have crossed over to be exposed to the intervention. At the end of the study there will be a period when all clusters are exposed. Data collection will continue throughout the study, so that each cluster will contribute observations under both control and intervention observation periods. Two years of baseline data will be obtained from all study sites for comparison.
Objective 2: Assess the contextual mechanisms influencing the adoption, reach, and effectiveness of EHR-based nudge interventions, with a lens for health equity in molecular testing using mixed-methods.
Using rigorous approaches proven successful in our prior work, we will recruit patient and clinician participants from each site to complete semi-structured interviews and structured questionnaires. The goal of this objective is to understand contextual mechanisms (e.g., patient, clinician, clinic, structural factors) shaping adoption, reach, and effectiveness of each intervention and identify how response may differ by key characteristics. These data will be analyzed using convergent mixed methods analysis, which employs the simultaneous collection and analysis of both quantitative and qualitative data to gain a comprehensive understanding of the multi-level factors shaping trial outcomes.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Penn Medicine New Jersey | Other | Behavioral: iNUDGEAll 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. |
| Penn Medicine Lancaster General Health | Other | Behavioral: iNUDGEAll 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. |
| Penn Presbyterian Medical Center | Other | Behavioral: iNUDGEAll 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 may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Participants with incomplete staging information.
- Children, pregnant women, fetuses, neonates, or prisoners are not included in this research study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iNUDGEElectronic health record nudge which prompts physicians to order plasma-based NGS testing for eligible patients with newly diagnosed lung cancer. | Behavioural | Penn Medicine Lancaster General Health, Penn Medicine New Jersey, Penn Presbyterian Medical Center |
Primary outcome
Availability of comprehensive molecular test results prior to first line therapy for patients with newly diagnosed mNSq NSCLC
Time frame: Measured up to 6 weeks from initial diagnosis
Were comprehensive molecular test results available prior to initiation of 1L therapy? (Yes/No)
7 secondary outcomes
Successful EHR based nudge delivery
Time frame: Measured up to 6 weeks from randomization
Turnaround time of delivery of provider focused alerts
Time frame: Measured up to 6 weeks from randomization
Completion of comprehensive molecular testing & modality used
Time frame: Measured up to 3 months from initial diagnosis
Reasons for failure to complete comprehensive molecular testing:
Time frame: Measured up to 3 months from initial diagnosis
Time to molecularly informed treatment initiation
Time frame: Measured up to 6 weeks from initial diagnosis
Type of therapy received
Time frame: Measured up to 3 months from initial diagnosis
Overall survival
Time frame: Measured up to 1 year from the time of randomization to death from any cause
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 11 Mar 2026.
- Background: PubMed 32918064Aggarwal 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.
- Background: PubMed 34246791Rolfo 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.
- Background: PubMed 30964529Singal 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.
- Background: PubMed 35313244Robert 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.
- Background: PubMed 27601595Thompson 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.
- Background: PubMed 30988079Leighl 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.
- Background: PubMed 30325992Aggarwal 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.
- Background: PubMed 32478025Shelton 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.
- Background: PubMed 31462482Rendle 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.
- Background: PubMed 24904704Kane 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.
- Background: PubMed 33308250Whitaker 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.
- Individual participant dataSharing planned: No. A Clinical Study Report will be made available to the study sponsor.
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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.
Charu Aggarwal, MD, MPH principal investigator
Penn Medicine
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iNUDGE in people with Non Small Cell Lung Cancer Metastatic and Newly Diagnosed NSCLC, run by Charu Aggarwal at 6 sites 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 2 inclusion and 2 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 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
Availability of comprehensive molecular test results prior to first line therapy for patients with newly diagnosed mNSq NSCLC (time frame: Measured up to 6 weeks from initial diagnosis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05853887, which also lists 11 linked publications.
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 11 Mar 2026.