Genotyping of Non-small Cell Lung Cancer

• Conditions: Non-small Cell Lung Cancer; Gene Abnormality
• Interventions: Other: DNA mass

• Registration Number: NCT02002117
• Lead Sponsor: National Taiwan University Hospital

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.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2013-09-09
• Study First Submitted QC: 2013-11-29
• Study First Posted: 2013-12-05
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-28
• Last Update Posted: 2014-07-30
• Primary Completion: 2015-04
• Study Completion: 2016-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
DNA mass spectrometry	DNA mass	DNA mass spectrometry

Primary Outcome Measures

Name	Time	Method
frequency of individual genotyping	2 months	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.

Secondary Outcome Measures

Name	Time	Method
response rate	1 year	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.
determine the frequency by DNA mass spectrometry	2 months	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.

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan