UnknownNot Applicable

Genotyping of Non-small Cell Lung Cancer

Taiwan100 participantsStarted 2012-01

Plain-language summary

The logical next step is to integrate molecular profiling into the care of all patients with NSCLC.

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Patients who have participated or will be participating a lung cancer clinical trial that use EGFR-TKI or chemotherapy as first line or second line treatment.
✓. Pathologic or cytological confirmation of non-small cell lung cancer (NSCLC) with available tissue
✓. Patients must understand and provide written informed consent prior to initiation of any study-specific procedures
✓. Have a life expectancy 3 months.
✓. Have stage IV NSCLC (AJCC, 7th Edition)
✓. No or one prior systemic therapy for advanced or metastatic NSCLC 6.1.Adjuvant chemotherapy: The adjuvant chemotherapy (e.g. vinorelbine / cisplatin) should be counted as one prior systemic therapy if the interval between the completion of adjuvant chemotherapy and the documentation of recurrence within 12 months.
✓.2.Maintenance therapy: The maintenance therapy (e.g. pemetrexed) following the first-line systemic chemotherapy which achieved complete response, partial response, or stable disease should not be counted as one prior systemic therapy if the maintenance drug was used in first-line combination therapy
✓. ≥20 years

✕. Prior history of another malignancy (other than cured basal cell carcinoma of the skin or cured in-situ carcinoma of the cervix) within 5 years of study entry.
✕. Known HIV infection.
✕. If subject has no archival tissue and refuse to do any biopsy or surgery for molecular testing

frequency of individual genotyping

Timeframe: 2 months

NCT IDNCT02002117

SponsorNational Taiwan University Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2015-04

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Patients who have participated or will be participating a lung cancer clinical trial that use EGFR-TKI or chemotherapy as first line or second line treatment.
✓. Pathologic or cytological confirmation of non-small cell lung cancer (NSCLC) with available tissue
✓. Patients must understand and provide written informed consent prior to initiation of any study-specific procedures
✓. Have a life expectancy 3 months.
✓. Have stage IV NSCLC (AJCC, 7th Edition)
✓. No or one prior systemic therapy for advanced or metastatic NSCLC 6.1.Adjuvant chemotherapy: The adjuvant chemotherapy (e.g. vinorelbine / cisplatin) should be counted as one prior systemic therapy if the interval between the completion of adjuvant chemotherapy and the documentation of recurrence within 12 months.
✓.2.Maintenance therapy: The maintenance therapy (e.g. pemetrexed) following the first-line systemic chemotherapy which achieved complete response, partial response, or stable disease should not be counted as one prior systemic therapy if the maintenance drug was used in first-line combination therapy
✓. ≥20 years

✕. Prior history of another malignancy (other than cured basal cell carcinoma of the skin or cured in-situ carcinoma of the cervix) within 5 years of study entry.
✕. Known HIV infection.
✕. If subject has no archival tissue and refuse to do any biopsy or surgery for molecular testing