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A prospective observational study to assess the utility of comprehensive genomic profiling in patients with non-small cell lung cancer without driver genetic alterations

A prospective observational study to assess the utility of comprehensive genomic profiling in patients with non-small cell lung cancer without driver genetic alterations identified by multiplex companion diagnostics - A prospective observational study to assess the utility of comprehensive genomic profiling in patients with non-small cell lung cancer without driver genetic alterations

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000052408
Enrollment
73
Registered
2023-10-06
Start date
2023-10-10
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

Non-small cell lung cancer

Interventions

None listed

Sponsors

Hamamatsu University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age equal to or more than 20 years at the time of study entry 2. Locally advanced, recurrent, or metastatic non-small cell lung cancer without druggable driver genetic alterations assessed by multiplex companion diagnostics 3. Standard treatment has been completed or is expected to be completed 4. Comprehensive genomic profiling tests are planned 5. Written informed consent obtained from the subject

Exclusion criteria

Exclusion criteria: 1. Patients who do not meet the insurance coverage of the National Health Insurance in Japan for comprehensive genomic profiling testing 2. Patients with driver genetic alterations that are druggable by approved agents determined by multiplex companion diagnostics at the time of diagnosis 3. Patients who received more than one line of systemic treatment after the completion of standard treatment

Design outcomes

Primary

MeasureTime frame
The proportion of patients with actionable cancer genomic alterations detected using comprehensive genomic profiling tests.

Secondary

MeasureTime frame
The proportion of patients with options of molecular-based recommended therapy (MBRT) determined by the molecular tumor board. The proportion of patients with druggable genomic alterations. The proportion of patients who received MBRT including clinical trials. The success rate of the comprehensive genomic profiling tests. Matching score of MBRT calculated using a matching score system. Response rate and progression-free survival in the treatment after comprehensive genomic profiling. Overall survival. Progression-free survival in MBRT.

Countries

Japan

Contacts

Public ContactYusuke Inoue

Hamamatsu University School of Medicine Second Division, Department of Internal Medicine

yinoue@hama-med.ac.jp81-53-435-2263

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026