BATTLE Program: Umbrella Protocol for Patients With NSCLC
The goal of this screening study is to find out if you are eligible to take part in 1 of 4 different research studies.
This trial is referred to as the "umbrella trial". The BATTLE program consists of this umbrella trial plus four phase II protocols into which the umbrella patients are enrolled. Patients will first enroll in the BATTLE umbrella trial and undergo a tumor biomarker analysis that will be used to assign them to one of the four phase II studies. All patients enrolled in one of the phase II BATTLE protocols must be enrolled in this protocol.
The primary objective of each of the phase II studies will be:
• To determine the 8-week progression-free survival rate (i.e. disease control rate) in patients with advanced NSCLC who have failed at least one prior chemotherapy regimen.
- Determine the overall response rate
- Determine the overall survival
- Determine the time to disease progression
- Assess the safety/toxicity of the study treatment(s)
- Assess biomarker modulation in the tumor tissue and serum samples from the treatment
- Assess plasma and intra-tumor concentrations of study treatment
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||A Biomarker-Integrated Study in Chemorefractory Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)|
- Biomarker Profile Assessment (before randomized allocation to research study) [ Time Frame: At enrollment ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
A sample of your tumor tissue will be collected for biomarker analysis, and based on the results, you will be assigned to one of four phase II studies.
|Study Start Date:||November 2006|
|Estimated Primary Completion Date:||November 2014 (Final data collection date for primary outcome measure)|
Screening study to find out if Patients with non-small cell lung cancer (NSCLC) that has spread to other parts of the body are eligible to take part in 1 of 4 different research studies.
Procedure: Tumor Biopsy
A sample of tumor tissue will be collected by either a CT-guided core biopsy, bronchoscopy, or other type of biopsy (such as subcutaneous, cutaneous, or lymph node).
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|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||William N. William Jr., MD||M.D. Anderson Cancer Center|