NCT03615443: NILE

Noninvasive vs. Invasive Lung Evaluation

Completed Last updated 3 May 2021

What this trial tests

trial testing Guardant360 in Non-Small Cell Lung Cancer in 306 participants. Completed in 23 November 2020.

Timeline

12 February 2016

Primary endpoint
23 November 2020

23 November 2020

Quick facts

Lead sponsor	Guardant Health, Inc.
Status	Completed
Study type	OBSERVATIONAL
Enrollment	306
Start date	12 February 2016
Primary completion	23 November 2020
Estimated completion	23 November 2020

Drugs / interventions tested

• Guardant360

Conditions studied

• Non-Small Cell Lung Cancer — all drugs for Non-Small Cell Lung Cancer →

Sponsor

Guardant Health, Inc.

Who can join

18 and older, any sex, with Non-Small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Tumor derived cell free DNA (cfDNA) is increasingly used in the clinic to obtain genotype information about lung cancer, but its concordance with concurrent tumor-derived sequenced data is not known. The purpose of the trial is to determine the non-inferiority of cfDNA-based vs. tumor tissue-based genotyping as it pertains to the detection of National Comprehensive Cancer Network (NCCN)-recommended biomarkers in first line, treatment naive, non-squamous Non-Small Cell Lung Cancer (NSCLC).

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Integrating circulating-free DNA (cfDNA) analysis into clinical practice: opportunities and challenges.
   García-Pardo M, Makarem M, Li JJN, Kelly D, et al · · 2022 · cited 94× · PMID 35347327 · DOI 10.1038/s41416-022-01776-9
2. A clinician's handbook for using ctDNA throughout the patient journey.
   Hasenleithner SO, Speicher MR. · · 2022 · cited 85× · PMID 35307037 · DOI 10.1186/s12943-022-01551-7
3. Current and future applications of liquid biopsy in non-small-cell lung cancer-a narrative review.
   Tomasik B, Skrzypski M, Bieńkowski M, Dziadziuszko R, et al · · 2023 · cited 26× · PMID 37057121 · DOI 10.21037/tlcr-22-742
4. Liquid Biopsies: Emerging role and clinical applications in solid tumours.
   Sisodiya S, Kasherwal V, Khan A, Roy B, et al · · 2023 · cited 21× · PMID 37327582 · DOI 10.1016/j.tranon.2023.101716
5. New Advances in Liquid Biopsy Technologies for Anaplastic Lymphoma Kinase (ALK)-Positive Cancer.
   Villa M, Sharma GG, Manfroni C, Cortinovis D, et al · · 2021 · cited 11× · PMID 34680298 · DOI 10.3390/cancers13205149
6. Utility of Circulating Tumor DNA in Different Clinical Scenarios of Breast Cancer.
   Mesquita A, Costa JL, Schmitt F, Schmitt F. · · 2020 · cited 8× · PMID 33339259 · DOI 10.3390/cancers12123797
7. Moving liquid biopsies to the Front-line of lung cancer treatment decisions.
   Raez LE, Carracedo C, Rosas D, Alvarez AM. · · 2023 · cited 1× · PMID 40027286 · DOI 10.1016/j.jlb.2023.100006