A prospective observational study to evaluate the detection rate of actionable mutations by liquid biopsy Guardant360 in patients with non-squamous non-small cell lung cancer (NSCLC) whose gene alterations are not detected by tissue-based singleplex assays. (WJOG13620L)

A prospective observational study to evaluate the detection rate of actionable mutations by liquid biopsy Guardant360 in patients with non-squamous non-small cell lung cancer (NSCLC) whose gene alterations are not detected by tissue-based singleplex assays. (WJOG13620L) - A prospective observational study by G360 in NSCLC patients whose gene alterations are not deteted by tissue-based singleplex assays. (WJOG13620L)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000041583

Enrollment

Registered

2020-08-31

Start date

2020-09-28

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically confirmed non-squamous NSCLC. 2) Stage 3B-4 and recurrent non-squamous NSCLC that is inoperable and chemoradiation therapy ineligible. 3) Men and women above 20. 4) EGFR gene is confirmed as wild type by a singleplex assay. The results of the other 7 genes tested are unknown or negative at the time of enrollment. 5) Comprehensive genomic profiling such as OncomineTM Dx Target Test, OncoGuideTM NCC Oncopanel System, and FoundationOne(R) CDx has not been examined. 6) No prior treatment with cytotoxic agent/molecular targeted therapy/ immune checkpoint inhibitor for advanced stage NSCLC (recurrence after postoperative adjuvant chemotherapy or chemoradiotherapy finished can be registered). 7) Treatable with anti-cancer drugs. Life expectancy >= 3 months. 8) Written informed consent after sufficient explanation.

Exclusion criteria

Exclusion criteria: 1) Multiple cancer with metastasis. 2) Severe psychological disease. 3) Not fit for this trial judged by the doctor in charge.

Design outcomes

Primary

Measure	Time frame
Detection rate of major actionable genomic alterations in 8 genes (EGFR (exon 18-21 indel or point mutation), ALK fusion, ROS1 fusion, BRAF (exon 15 V600E point mutation), MET exon 14 skipping, RET fusion, ERBB2 exon 20 insertion, KRAS (exon 2-3 point mutation), NTRK fusion) by Guardant360.	—

Secondary

Measure	Time frame
Detection rate of each 9 genomic alteration by Guardant360, rate of the patient whose gene alterations are detected by companion diagnostics based on the result of Guardant360, rate of the patient treated with molecular-targeted drugs, and turn-around time	—

Countries

Japan

Contacts

Public ContactShinichiro Nakamura

West Japan Oncology Group WJOG datacenter

datacenter@wjog.jp06-6633-7400

Outcome results