NCT05935384 is a clinical trial of Guardant360 in Non-small Cell Lung Cancer, sponsored by Guardant Health, Inc..

Who is sponsoring NCT05935384?

NCT05935384 is sponsored by Guardant Health, Inc..

What drugs are being tested in NCT05935384?

Interventions in NCT05935384: Guardant360.

What condition does NCT05935384 study?

NCT05935384 studies Non-small Cell Lung Cancer, Colorectal Cancer, Breast Cancer.

Is NCT05935384 still recruiting?

NCT05935384 is currently recruiting now. Last updated 22 August 2025.

Last reviewed 2025-08-22 · How we verify

NCT05935384

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

SIBYL: obServation of Therapy Response With lIquid BiopsY evaLuation

Recruiting now Last updated 22 August 2025

What this trial tests

trial testing Guardant360 in Non-small Cell Lung Cancer in 470 participants. Currently enrolling.

Timeline

25 October 2023

Primary endpoint
30 December 2030

30 December 2030

Quick facts

Lead sponsor	Guardant Health, Inc.
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	470
Start date	25 October 2023
Primary completion	30 December 2030
Estimated completion	30 December 2030
Sites	1 location across United States

Drugs / interventions tested

Guardant360

Conditions studied

Non-small Cell Lung Cancer — all drugs for Non-small Cell Lung Cancer →
Colorectal Cancer — all drugs for Colorectal Cancer →
Breast Cancer — all drugs for Breast Cancer →

Sponsor

Guardant Health, Inc.

Who can join

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

Sponsor's own description

The purpose of SIBYL is to generate clinical validity data for the ability of a future version of Guardant360 developed by Guardant Health to measure response to systemic therapy in patients with unresectable advanced solid tumors. It is necessary to collect clinical data points and treatment outcomes in order to demonstrate clinical validity for longitudinal monitoring with ctDNA and correlation of ctDNA dynamics with therapeutic response, as evaluated by standard methods, including RECIST 1.1 and CT scan measurements.

Publications & conference data

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

Decoding the Dynamics of Circulating Tumor DNA in Liquid Biopsies.
Turabi K, Klute K, Radhakrishnan P. · · 2024 · cited 14× · PMID 39001494 · DOI 10.3390/cancers16132432
Harnessing liquid biopsies: Exosomes and ctDNA as minimally invasive biomarkers for precision cancer medicine.
Bamodu OA, Chung CC, Pisanic TR. · · 2023 · cited 13× · PMID 40028482 · DOI 10.1016/j.jlb.2023.100126
Liquid Biopsies in the Early Diagnosis, Prognosis, and Tailored Treatment of Colorectal Cancer.
Liatsou E, Kollias I, Trapali M, Tsilimigras DI, et al · · 2025 · cited 4× · PMID 40149264 · DOI 10.3390/cancers17060927
Liquid biopsy in breast cancer: Redefining precision medicine.
Schiavone ML, Scarpitta R, Ravera F, Bleve S, et al · · 2025 · cited 3× · PMID 40740670 · DOI 10.1016/j.jlb.2025.100312

Verify or expand the search:

Other trials of Guardant360

Trials testing the same drug.

NCT03615443 — Noninvasive vs. Invasive Lung Evaluation · completed

Other recruiting trials for Non-small Cell Lung Cancer

Currently open trials in the same condition.

NCT07431827 — MK-3475A±Calderasib (MK-1084) in Completely Resected Stage IIA-IIIB (N2) KRAS G12Cm NSCLC (MK-1084-013) · Phase 3 · recruiting
NCT05987956 — Pharmacogenomics IND EXEMPT SNP Clinical Trial - Alectinib and Single Nucleotide Polymorphisms · Phase 2, PHASE3 · active not recruiting
NCT07195695 — Beamion LUNG-3: A Study to Test Whether Zongertinib Helps People With Surgically Removed, Non-small Cell Lung Cancer Wit · Phase 3 · recruiting
NCT06686771 — Radiotherapy to Block Oligoprogression In Metastatic Non-Small-Cell Lung Cancer · Phase 3 · recruiting
NCT06477055 — The Recurrence Gene Profiles of Adjuvant Osimertinib Therapy in Resected Non-Small-Cell Lung Cancer · recruiting

Other Guardant Health, Inc. trials

Trials by the same sponsor.

NCT06880055 — Shield Post-Approval Study Protocol · recruiting
NCT05117840 — Screening for High Frequency Malignant Disease · active not recruiting
NCT04436393 — Guardant360® Related Clinical Outcomes in Patients Who Share Medical Records-Breast Cancer · completed
NCT04136002 — Evaluation of the ctDNA LUNAR Test in an Average Patient Screening Episode · completed
NCT03625557 — Guardant360® Test-Related Clinical Outcomes in Patients Who Share Medical Records · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05935384 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Guardant Health, Inc.
Last refreshed: 22 August 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05935384.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing