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
- Conditions
- on-Small Cell Lung Cancer
- Registration Number
- JPRN-jRCT1030210622
- Lead Sponsor
- Hiroshi Kitagawa
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 240
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.
None
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The agreement in assessment of tumor cell proportion between Local pathologist and Central Pathology Committee
- Secondary Outcome Measures
Name Time Method