Clinical trial NCT02002117: Genotyping of Non-small Cell Lung Cancer
Official title: Genotyping of Non-small Cell Lung Cancer Cells - A Study of Taiwan Lung Cancer Clinical Trial Consortium (TALCC)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non-small Cell Lung Cancer
Gene Abnormality
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2013-12-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: PROBABILITY_SAMPLE
Study population: We plan to collect 300 EGFR mutation positive samples (approximately 200 de novo, 100 after treatment), 200 EGFR wild type adenocarcinoma patients and 100 other NSCLC patients in 3 years.

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

Detailed description: NSCLC is an area of oncology in which clinicians are beginning to use specific tumor-associated molecular aberrations to assign and/or prioritize targeted therapies for patients. At this early stage, multiple hurdles remain before molecular profiling becomes a routine part of thoracic oncology practice. In particular, to develop specific targeted therapies for patients whose tumors harbor rare mutations, it will be important to identify appropriate candidates, design the appropriate trials, and execute the trials with adequate numbers to achieve the necessary endpoints. Implementation will facilitate realization of the promise of molecularly tailored therapy, which could lead to more effective treatments with fewer side effects.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. Pathologic or cytological confirmation of non-small cell lung cancer (NSCLC) with available tissue
3. Patients must understand and provide written informed consent prior to initiation of any study-specific procedures
4. Have a life expectancy 3 months.
5. Have stage IV NSCLC (AJCC, 7th Edition)
6. 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.

   6.2.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
7. ≥20 years
8. ECOG performance status 0 - 2
9. If there is no available archived tissue, the subject must consent to undergo a biopsy or surgical procedure to obtain tissue within 1 month prior to study entry, which may or may not be part of the patient's routine care for their malignancy.

Exclusion Criteria:

1. 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.
2. Known HIV infection.
3. If subject has no archival tissue and refuse to do any biopsy or surgery for molecular testing

Primary outcomes:
measure: frequency of individual genotyping
timeFrame: 2 months
Secondary outcomes:
measure: determine the frequency by DNA mass spectrometry
timeFrame: 2 months
measure: response rate
timeFrame: 1 year
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
name: Chih-Hsin Yang, PhD
role: PRINCIPAL_INVESTIGATOR
References: