Genotyping of Non-small Cell Lung Cancer

Non-small Cell Lung Cancer Clinical Trial

Official title:

Genotyping of Non-small Cell Lung Cancer Cells - A Study of Taiwan Lung Cancer Clinical Trial Consortium (TALCC)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02002117
• Other study ID #: 201103039RB
• Status: Recruiting
• Phase: N/A
• First received: September 9, 2013
• Last updated: July 28, 2014
• Start date: January 2012
• Est. completion date: April 2016

Study information

• Verified date: July 2014
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 2016
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Gene Abnormality
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Other:
• DNA mass
DNA mass spectrometry

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	frequency of individual genotyping	To determine the frequency of individual genotyping in cancer cells of advanced non-small cell lung cancer (NSCLC) patients who have participated or will commence the clinical trial.	2 months	No
Secondary	determine the frequency by DNA mass spectrometry	To determine the frequency with which molecular profiling of a NSCLC patient's tumor by DNA mass spectrometry yields a target against which there is approved or investigational therapeutic regimen.	2 months	No
Secondary	response rate	To determine the response rate according to RECIST, progression-free, and overall survival in patients with advanced NSCLC whose therapy is selected by molecular profile.	1 year	No