Study Using a Genomic Predictor of Platinum Resistance to Guide Therapy in Stage IIIB/IV Non-Small Cell Lung Cancer
Public ClinicalTrials.gov record NCT00509366. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Phase II Prospective Study Evaluating the Role of Personalized Chemotherapy Regimens for Chemo-Naive Select Stage IIIB and IV Non-Small Cell Lung Cancer (NSCLC) in Patients Using a Genomic Predictor of Platinum Resistance to Guide Therapy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
In this trial, subjects with chemo-naive advanced non-small cell lung cancer (NSCLC) were assigned to chemotherapy using a genomic-based predictor for platinum sensitivity. After an amendment dated 1/25/2010, subjects with squamous cell NSCLC sensitive to cisplatin received cisplatin/gemcitabine and if resistant to cisplatin received docetaxel/gemcitabine. Subjects with non-squamous cell NSCLC sensitive to cisplatin received cisplatin/pemetrexed and if resistant to cisplatin received pemetrexed/gemcitabine. The primary objective of this trial was to prospectively validate the genomic-based prediction model through separate evaluation of the one-year progression-free survival (PFS) of the cisplatin-sensitive and cisplatin-resistant cohorts. Secondary objectives included: assessment of overall time to progressive disease, quality of life and evaluation of drug sensitivity patterns of cisplatin and pemetrexed.
Study identification
- NCT ID
- NCT00509366
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 101 participants
Conditions and interventions
Conditions
Interventions
- Cisplatin & Gemcitabine Drug
- Cisplatin & Pemetrexed Drug
- Docetaxel & Gemcitabine Drug
- Pemetrexed & Gemcitabine Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 30, 2007
- Primary completion
- Nov 30, 2011
- Completion
- Nov 30, 2011
- Last update posted
- Aug 27, 2014
2007 – 2011
United States locations
- U.S. sites
- 8
- U.S. states
- 3
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Maria Parham Hospital | Henderson | North Carolina | 27536 | — |
| Scotland HealthCare System (Scotland Memorial Hospital) | Laurinburg | North Carolina | 28352 | — |
| Southeastern Regional Medical Center, Gibson Cancer Center | Lumberton | North Carolina | 28358 | — |
| Duke Raleigh Hospital | Raleigh | North Carolina | 27609 | — |
| Beaufort Memorial Hospital | Beaufort | South Carolina | 29902 | — |
| Coastal Cancer Center | Myrtle Beach | South Carolina | 29572 | — |
| Community Memorial Health Center | South Hill | Virginia | 23970 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00509366, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 27, 2014 · Synced Sep 9, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00509366 live on ClinicalTrials.gov.