Assessment of tumor proportion for biomarker tests prior to the selection of first-line therapy in advanced non-squamous non-small cell lung cancer patients in the real world setting in Japan: a prospective, multicenter, observational study

Assessment of tumor proportion for biomarker tests prior to the selection of first-line therapy in advanced non-squamous non-small cell lung cancer patients in the real world setting in Japan: a prospective, multicenter, observational study - ASTRAL study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1030210622

Enrollment

240

Registered

2022-02-19

Start date

2022-03-09

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Patient aged at least 20 years at the time of consent. 2.Pathologically confirmed non-squamous NSCLC. 3.Newly diagnosed, locally advanced (clinical stage IIIB, IIIC) or metastatic NSCLC (clinical stage IVA or IVB) or recurrent NSCLC (per Version 8 of the International Association for the Study of Lung Cancer [IASLC] Staging Manual in Thoracic Oncology), not amenable to curative surgery or radiotherapy 4.Treatment- naive for locally advanced/ metastatic/ recurrent NSCLC 5.Tumor cell proportion was assessed using FFPE samples and biomarker test was ordered within the period between diagnosis of locally advanced/ metastatic/ recurrent NSCLC and starting 1st line treatment. 6.Provision of informed consent prior to the start of 1st line therapy and any study specific procedures.

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

Measure	Time frame
The agreement in assessment of tumor cell proportion between Local pathologist and Central Pathology Committee	—

Secondary

Measure	Time frame
1. The agreement in assessment of tumor cell proportion between Machine learning algorithm and other raters (vs. Local pathologist, vs. Central Pathology Committee) ICC Bland-Altman analysis 2. Distribution of categories based on differences in tumor cell proportion assessment value between raters by grade (none/ mild, moderate, severe) of each pathological finding (Inflammatory cells, Fibrosis, Mucous, Necrosis, Crush) The categories will be following Underestimation, Complete agreement, Overestimation Non/ slight, Moderate, Considerable Both raters (A and B) = 30percent, Rater A >= 30percent and Rater B = 30percent Diagnosis performance regarding tumor cell proportion between raters dichotomized based on the cut-off values of 10, 20 and 30percent using assessment by Central Pathology Committee as the gold standard the concordance rate, sensitivity, specificity, positive predictive value, negative predictive value, and The Cohen kappa coefficient 3. Success rate of ODxTT and AmoyDx Pan Lung Cancer PCR Panel 1)Success rate in ODxTT and AmoyDx Pan Lung Cancer PCR Panel 2)Success rate of each biomarker in ODxTT and AmoyDx Pan Lung Cancer PCR Panel 3)ODxTT and AmoyDx Pan Lung Cancer PCR Panel success rate by sample condition 4)Sample conditions by success or unsuccess of ODxTT and AmoyDx Pan Lung Cancer PCR Panel 4. Testing results of each biomarker measured by ODxTT and other methods 5. Categories of 1st line treatment regimens	—

Measure

Time frame

1. The agreement in assessment of tumor cell proportion between Machine learning algorithm and other raters (vs. Local pathologist, vs. Central Pathology Committee) ICC Bland-Altman analysis 2. Distribution of categories based on differences in tumor cell proportion assessment value between raters by grade (none/ mild, moderate, severe) of each pathological finding (Inflammatory cells, Fibrosis, Mucous, Necrosis, Crush) The categories will be following Underestimation, Complete agreement, Overestimation Non/ slight, Moderate, Considerable Both raters (A and B) = 30percent, Rater A >= 30percent and Rater B = 30percent Diagnosis performance regarding tumor cell proportion between raters dichotomized based on the cut-off values of 10, 20 and 30percent using assessment by Central Pathology Committee as the gold standard the concordance rate, sensitivity, specificity, positive predictive value, negative predictive value, and The Cohen kappa coefficient 3. Success rate of ODxTT and AmoyDx Pan Lung Cancer PCR Panel 1)Success rate in ODxTT and AmoyDx Pan Lung Cancer PCR Panel 2)Success rate of each biomarker in ODxTT and AmoyDx Pan Lung Cancer PCR Panel 3)ODxTT and AmoyDx Pan Lung Cancer PCR Panel success rate by sample condition 4)Sample conditions by success or unsuccess of ODxTT and AmoyDx Pan Lung Cancer PCR Panel 4. Testing results of each biomarker measured by ODxTT and other methods 5. Categories of 1st line treatment regimens

—

Contacts

Public ContactTamai Yoichi

AstraZeneca K.K.

Yoichi.Tamai@astrazeneca.com+81-6-4802-3600

Outcome results