Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

ZD6474 300 mg by mouth daily for 28 Days.

ZD6474

Anne S. Tsao, MD

Primary Objective:

* 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.

Secondary Objectives:

* Determine the overall response rate
* Determine the overall survival
* Determine the time to disease progression
* Assess the safety/toxicity of the study treatment
* Assess biomarker modulation in the tumor tissue and serum samples from the treatment
* Assess plasma and intra-tumor concentrations of study treatment

ZD6474 is designed to block the formation of new blood vessels. The growth of new blood vessels is called angiogenesis. Angiogenesis is thought to be important for the growth of tumors beyond a small size. Researchers want to find out if ZD6474 will limit new blood vessel growth in the tumor and "starve" the tumor by limiting blood flow to it.

In order to enroll in this study, you must also be enrolled in Protocol 2005-0823: A Biomarker-integrated study in Chemorefractory Patients with Advanced Non-Small Cell Lung Cancer. Protocol 2005-0823 is the screening study in a group of studies called the BATTLE program. Participants in Protocol 2005-0823 are assigned to one of the research studies. The results of your tumor analysis helped the study doctor determine to assign you to this particular treatment study.

While on study, you will take ZD6474 by mouth each morning. ZD6474 is swallowed as a whole tablet. The tablet should not be chewed, crushed, or divided and should be taken with 8 ounces of water and a small amount of food to lessen stomach discomfort. You should take ZD6474 at about the same time every day. Four (4) weeks is considered 1 treatment cycle. If you miss a dose and are unable to take the missed dose on the same day, you should take the next scheduled dose and the missed dose will not be made up. The dose of study medication may be repeated if vomiting occurs within 30 minutes of taking the study medication.

You will have routine blood tests (about 2 teaspoons) at Weeks 1, 2, 4, 8, 12, then every 4 weeks after that. You will have an electrocardiogram (ECG -- a test that measures the electrical activity of the heart) at Weeks 1, 2, 4, 8, 12, then every 3 months after that. Every 4 weeks, your complete medical history will be recorded and you will have a physical exam, including measurement of vital signs (blood pressure, heart rate, temperature, and breathing rate), a performance status evaluation, and weight. You will also have a routine urine test and your study doctor will ask you about any medications you are taking and your smoking history.

Every 2 cycles, your tumor will be evaluated by chest x-ray and computed tomography (CT) or magnetic resonance imaging (MRI) scans to evaluate the status of the disease. If you are taking coumadin, you will have blood drawn (about 1-2 teaspoons) to check your blood clotting function every week. You will be asked to bring your unused medication to each clinic visit.

You may continue receiving ZD6474 for as long as the cancer responds to study treatment. Your doctor may decide to take you off this study if you experience intolerable side effects, your medical condition gets worse, and/or you are unable to comply with study requirements. If you stop study treatment, you may be able to enroll in 1 of the remaining 3 protocols of the BATTLE program.

After you have stopped taking the study treatment, you will have a physical exam, including measurement of vital signs. Blood (about 2 teaspoons) and urine will be collected for routine tests. You will also have blood drawn (about 1-2 teaspoons) to check your blood clotting function. You will have a performance status evaluation, chest x-ray, ECG, and a CT or MRI scan. Following this evaluation, you will be contacted by telephone every 3 months for up to 3 years to see how you are doing.

You have the right to leave the study at any time. If you choose to stop participating in this study, you should contact the study chair and/or research nurse.

This is an investigational study. ZD6474 is an investigational drug that has been approved by the FDA for research use only. Up to 72 patients will take part in this multicenter study. All will be enrolled at M. D. Anderson.

BATTLE Program: ZD6474 in Previously Treated Subjects With NSCLC

A Phase II, Open Label Study of ZD6474 in Previously Treated Subjects With Advanced Non-Small Cell Lung Cancer (NSCLC)

The disease control rate (DCR) is the percentage of patients without progression at 8 weeks. Disease control rate defined as: Complete Response (CR): Disappearance of all non-target/target lesions and normalization of tumor marker level. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD since the treatment started.

Progression-free survival (PFS) was estimated using Kaplan-Meier method. PFS was defined as time from start of treatment to disease progression.

United States Department of Defense

AstraZeneca

M.D. Anderson Cancer Center

Collection period: January 16, 2007 to April 02, 2010.

Age, Continuous

<=50 years

Between 51 and 60 years

Between 61 and 70 years

>70 years

Age, Customized

Sex: Female, Male

United States

Region of Enrollment

Anne S. Tsao, MD / Associate Professor, Thoracic/Head & Neck Med Oncology

8 Week Progression-Free Survival

8-Week Disease Control Rate (Complete Response, Partial Response and Stable Disease)

Overall Study

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Erlotinib Hydrochloride

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Erlotinib 150 mg by mouth daily x 28 days.

Erlotinib

Erminia Massarelli, MD, PHD

The goal of this clinical research study is to learn if erlotinib hydrochloride (OSI-774, Tarceva®) can help to control NSCLC. The safety of this drug will also be studied, as well as the drug's effect on different cells in the body and the participants' overall response.

Erlotinib hydrochloride is designed to block the activity of an enzyme found on the surface of many tumor cells that may slow tumor growth.

In order to enroll in this study, you must also be enrolled in Protocol 2005-0823: A Biomarker-integrated study in Chemorefractory Patients with Advanced Non-Small Cell Lung Cancer. Protocol 2005-0823 is the screening study in a group of studies called the BATTLE program. Participants in Protocol 2005-0823 are assigned to one of the research studies. The results of your tumor analysis helped the study doctor determine to assign you to this particular research study.

While on study, you will take erlotinib hydrochloride by mouth once a day. Tablets should be taken preferably in the morning 1 hour before or 2 hours after a meal with no more than 7 ounces of water. If you are unable to swallow tablets, you may dissolve the tablets in distilled water. If you forget to take a dose, the last missed dose should be taken as soon as you remember, as long as it is at least 12 hours before the next dose is due to be taken. The next day, you should take the scheduled dose at the usual time. Every attempt should be made to keep from vomiting the medication for at least 30 minutes after taking it. For example, if you feel nauseated before or after taking the erlotinib, anti-nausea medications should be used. The dose of erlotinib hydrochloride may be repeated if vomiting occurs within 30 minutes of taking the tablet. Four (4) weeks is considered 1 treatment cycle.

Every 4 weeks, your complete medical history will be recorded and you will have a physical exam, including measurement of vital signs (blood pressure, pulse, temperature, breathing rate) and weight. You will have blood drawn (about 2 teaspoons) for routine tests. You will have a performance status evaluation (questions about your ability to perform everyday activities). Your study doctor will ask you about any medications you are taking and your smoking history. Every 2 cycles, the tumor will be evaluated by chest x-ray and computed tomography (CT) or magnetic resonance imaging (MRI) scans to evaluate the status of the disease. If you are taking warfarin, you will have blood drawn (about 1-2 teaspoons) to check your blood clotting function weekly for the first 5 weeks of treatment and then every cycle after that.

You may continue receiving erlotinib hydrochloride for as long as the cancer responds to study treatment. Your doctor may decide to take you off this study if you experience intolerable side effects, your medical condition gets worse, or you are unable to comply with study requirements. If you stop study treatment, you may be able to enroll in 1 of the remaining 3 protocols of the BATTLE program. You should discuss this with your doctor.

After you have stopped taking the study treatment, you will have a physical exam, including measurement of vital signs. Blood (about 2 teaspoons) and urine will be collected for routine tests. You will also have blood drawn (about 1-2 teaspoons) to check your blood clotting function. You will have a performance status evaluation, a chest x-ray, and a CT or MRI scan. Following this evaluation, you will be contacted by telephone every 3 months for up to 3 years, to see how you are doing.

You have the right to leave the study at any time. If you choose to stop participating in this study, you should contact the study chair and/or research nurse. Your doctor may decide to take you off this study if your medical condition gets worse and/or you are unable to comply with study requirements.

This is an investigational study. Erlotinib hydrochloride is approved by the FDA for treatment of NSCLC in patients who have relapsed. Up to 72 patients will take part in this study. All will be enrolled at M. D. Anderson.

BATTLE Program: Erlotinib in Previously Treated Subjects With Advanced NSCLC

A Phase II, Open Label Study of Erlotinib (Tarceva) in Previously Treated Subjects With Advanced Non-Small Cell Lung Cancer

Progression-free survival (i.e. disease control rate) defined as percentage of participants without progression at 8 weeks, evaluation after the second cycle of therapy (i.e., 8 weeks), with confirmation of efficacy 2 cycles after its initial assessment. A "success" or "disease control" to treatment is defined as a participant being progression free at 8 weeks after randomization.

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Vice President Clinical Research/Clinical Research Operations

One participant was not evaluable for outcome.

8 Week Progression-Free Survival Rate (i.e. Disease Control Rate)

Sorafenib

Sorafenib 400 mg By Mouth Twice Daily for 28 Days.

George Blumenschein, MD

Primary Objective:

* To determine the 8 week progression-free survival rate (i.e. disease control rate) in patients with advanced non-small cell lung cancer (NSCLC) who have failed at least one prior chemotherapy regimen.

Secondary Objective:

The secondary objectives of this study will be to:

* Determine the overall response rate
* Determine the overall survival
* Determine the time to disease progression
* Assess the safety/toxicity of the study treatment
* Assess biomarker modulation in the tumor tissue and serum samples from the treatment.
* Assess plasma and intra-tumor concentrations of study treatment

BAY 43-9006® (Sorafenib) is an experimental agent designed to stop the growth of cancer cells.

In order to enroll in this study, you must also be enrolled in Protocol 2005-0823: A Biomarker-integrated study in Chemorefractory patients with advanced Non-Small Cell Lung Cancer. Protocol 2005-0823 is the screening study in a group of studies called the BATTLE program. Participants in Protocol 2005-0823 are assigned to one of the treatment studies. The results of your tumor analysis helped the study doctor determine to assign you to this particular treatment study.

While on study, you will take 2 tablets of sorafenib each morning, and again each evening. Sorafenib should be taken with about 1 cup of water on an empty stomach (either 1 hour before a meal or 2 hours after a meal). Sorafenib must be swallowed whole without chewing. If you feel nauseated before or after taking the medication, anti-nausea medications should be used. If you miss a dose, you should skip it and take the next scheduled dose at the right time. Your medication should be stored at room temperature.

Every 4 weeks (1 cycle) your complete medical history will be recorded and you will have a physical exam, including measurement of vital signs (blood pressure, pulse, temperature, and breathing rate) and weight. Blood (about 2 teaspoons) and urine will be drawn for routine tests. You will have a performance status evaluation (questions about your ability to perform everyday activities) and blood drawn (about 1-2 teaspoons) to check your blood clotting function. Your study doctor will also ask you about any medications you are taking and your smoking history. You will be asked to record your weekly blood pressure for the first 6 weeks of study treatment. The study doctor or research nurse will review the log at each clinic visit.

Every 2 cycles, your tumor will be evaluated by chest x-ray and computed tomography (CT) or magnetic resonance imaging (MRI) scans to evaluate the status of the disease. If you are taking Coumadin® (warfarin), you will have blood drawn (about 1-2 teaspoons) to check your blood clotting function weekly for the first 6 weeks of treatment and then every cycle after that.

You may continue receiving sorafenib for as long as the cancer responds to study treatment. Your doctor may decide to take you off this study if you experience intolerable side effects or your medical condition gets worse. If you stop study treatment, you will be allowed to enroll in one of the remaining 3 protocols of the BATTLE program.

After you have stopped taking the study treatment, you will have a physical exam, including measurement of vital signs. Blood (about 2 teaspoons) and urine will be collected for routine tests. You will also have blood drawn (about 1-2 teaspoons) to check your blood clotting function. You will have a performance status evaluation, a chest x-ray, and a CT or MRI scan. Following this evaluation, you will be contacted by telephone every 3 months for up to 3 years, to see how you are doing.

You have the right to leave the study at any time. If you choose to stop participating in this study, you should contact the study chair and/or research nurse. Your doctor may decide to take you off this study if your medical condition gets worse and/or you are unable to comply with study requirements.

This is an investigational study. Sorafenib (BAY 43-9006) has been approved by the FDA for treatment of advanced renal cell cancer; however, it's use in this research study is investigational. Up to 62 patients will take part in this multicenter study. Up to 50 will be enrolled at M. D. Anderson.

BATTLE Program: Sorafenib in Patients With NSCLC

A Phase II Study of Sorafenib (BAY 43-9006) in Chemorefractory Patients With Advanced Non-small Cell Lung Cancer (NSCLC)

The disease control rate (DCR) was defined as the proportion of patients who did not meet Response Evaluation Criteria in Solid Tumors (RECIST) criteria for progressive disease (PD) at 8 weeks. Progressive disease was defined as at least a 20% increase in the sum of longest diameter (LD) of measured lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

The Progression-Free Survival (PFS) was measured from date of randomization until progressive disease (PD) or death respectively.

Tumor responses was measured according to RECIST criteria. Tumor responses were defined as: Partial Response (PR): at least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD. Stable Disease (SD): steady state of disease. Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Progressive Disease (PD): at least a 20% increase in the sum of LD of measured lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

Bayer

Collection period: December 18, 2006 to November 13, 2010.

Sorafenib 400 mg by mouth twice daily in continuous 28 day cycles.

Sorafenib 400 mg

< 60 years

>= 60 years

George Blumenschein, MD / Professor, Thoracic/Head & Neck Med Oncology

Of the enrolled participants, 98 were evaluable for the outcome.

8-Week Disease Control Rate

Of the enrolled participants, only 98 were evaluable for the outcome.

Progression-Free Survival

Patial Response

Stable Disease

Progressive Disease

Early Progression

Tumor Response Measured Every 8-weeks

Carcinoma

Carcinoma, Bronchogenic

Bronchial Neoplasms

Bexarotene

Bexarotene 400 mg/m\^2 by mouth daily x 28 Days. Erlotinib 150 mg by mouth daily x 28 Days.

Vali Papadimitrakopoulou, MD

The goal of this clinical research study is to evaluate the effectiveness of Tarceva® (OSI-774, erlotinib hydrochloride) in combination with Targretin® (bexarotene) in treating NSCLC. The safety of this treatment will also be studied, as well as the treatment's effect on different cells in the body and the participants' overall response.

Erlotinib hydrochloride is designed to help block the activity of an enzyme that is believed to play an important role in cell growth. Researchers want to find out if blocking these enzymes will slow tumor growth. Bexarotene is designed to control cancer cell growth and division.

In order to enroll in this study, you must also be enrolled in Protocol 2005-0823 (NCT00409968): A Biomarker-integrated study in Chemorefractory Patients with Advanced Non-Small Cell Lung Cancer. Protocol 2005-0823 (NCT00409968) is the screening study in a group of studies called the BATTLE program. Participants in Protocol 2005-0823(NCT00409968) are assigned to one of the research studies. The results of your tumor analysis helped the study doctor determine to assign you to this particular research study.

While on study, you will take erlotinib hydrochloride and bexarotene by mouth once a day. Erlotinib hydrochloride tablets should be taken preferably in the morning 1 hour before or 2 hours after a meal with no more than 7 ounces of water. If you forget to take a dose, the last missed dose should be taken as soon as you remember, as long as it is at least 12 hours before the next dose is due to be taken. The next day, you should take the scheduled dose at the usual time.

Bexarotene capsules should be taken with or immediately after a meal. If you miss a dose, take it as soon as possible, with food. However, if it is nearly time for your next dose, skip the missed dose and continue your dose schedule as before.

Every attempt should be made to keep from vomiting the medication for at least 30 minutes after taking it. For example, if you feel nauseated before or after taking the medication, anti-nausea medications should be used.

The erlotinib hydrochloride tablets and bexarotene capsules should be stored at room temperature. Bexarotene capsules should not be stored near heating devices, high temperatures or humidity, or where children or pets have access to them. Bexarotene capsules should be protected from sunlight.

Every 4 weeks (1 cycle) your medical history will be recorded and you will have a physical exam, including measurement of vital signs (blood pressure, pulse, temperature, and breathing rate) and weight. You will have routine blood tests (about 2 teaspoons) and a performance status evaluation (questions about your ability to perform everyday activities). You will have blood drawn (about 1-2 teaspoons) to check you thyroid function. You will also have blood drawn (about 1-2 teaspoons) to check your lipid profile weekly for the first 4 weeks and then every cycle after that. Your study doctor will also ask you about any medications you are taking and your smoking history.

Every 2 cycles, your tumor will be evaluated by chest x-ray and computed tomography (CT) or magnetic resonance imaging (MRI) scans to evaluate the status of the disease. If you are taking Coumadin® (warfarin), you will have blood drawn (about 1-2 teaspoons) to check your blood clotting function weekly for the first 5 weeks of treatment and then every cycle after that.

You may continue receiving erlotinib hydrochloride and bexarotene for as long as the cancer responds to study treatment. Your doctor may decide to take you off this study if you experience intolerable side effects, your medical condition gets worse, or you are unable to comply with study requirements. If you stop study treatment, you may be able to enroll in 1 of the remaining 3 protocols of the BATTLE program.

After you have stopped taking the study treatment, you will have a physical exam, including measurement of vital signs. Blood (about 2 teaspoons) and urine will be collected for routine tests. You will also have blood drawn (about 1-2 teaspoons) to check your blood clotting function. You will have a performance status evaluation, a chest x-ray, and a CT or MRI scan. Following this evaluation, you will be contacted by telephone every 3 months for up to 3 years, to see how you are doing.

This is an investigational study. Erlotinib hydrochloride is approved by the FDA for treatment of NSCLC in patients who have relapsed. Bexarotene is approved by the FDA for the treatment of cutaneous T-cell lymphoma (CTCL). Their use together in this study is investigational. Up to 72 patients will take part in this multicenter study. All will be enrolled at M. D. Anderson.

BATTLE Program: Tarceva and Targretin in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

A Phase II Study of Erlotinib (Tarceva) in Combination With Bexarotene (Targretin) in Chemorefractory Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

The primary objective is 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. A radiologist independently assessed DC, which was defined as a complete or partial response or stable disease according to the RECIST(29) at the end of 8 weeks (start of treatment to end of second treatment cycle). PFS was assessed from the date of randomization to the earliest sign of disease progression or death from any cause. OS was assessed from the date of randomization until death from any cause. Tumor response was assessed every 8 weeks until disease progression. Toxicity was assessed in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0.

Bexarotene 400 mg/m\^2 by mouth daily x 28 Days. Erlotinib 150 mg by mouth daily x 28 Days.

Bexarotene: 400 mg/m\^2 by mouth daily x 28 Days

Erlotinib: 150 mg by mouth daily x 28 Days

Erlotinib + Bexatrtene

Bexarotene + Erlotinib

51-60 years

61-70 years

Dr. John V Heymach, PHD/ Chair, Thoracic-Head & Neck Med Onc

EGFR

KRAS/BRAF

VEGF/VEGFR-2

RXR/Cyclin D1

None

Erlotinib 150 mg by mouth daily + bexarotene 400 mg/m2/day daily (1 cycle =4 weeks) for 2 cycles, tumor response will be evaluated at the end of the second cycle. Patients who have progressed stop treatment and can renter the main BATTLE protocol and be assigned to another Phase II trial.

The primary end point was the 8-week DCR \[complete or partial response or stable disease via Response Evaluation Criteria in Solid Tumors (RECIST, which we compared with the historical 30% DCR estimate in similar patients. Treatment efficacy (a positive finding) was defined as \>0.80 probability of achieving\>30% DCR.

Number of Participants With 8-week Progression-Free Survival (i.e. Disease Control Rate) Stratified by Cancer Mutation Type

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.

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).

Tumor Biopsy

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.

This study is the "umbrella" or screening study in a group of 5 studies known as the BATTLE (Biomarker-integrated Approaches of Targeted Therapy of Lung Cancer Elimination) program. In order to participate in one of the research studies, you must first agree to take part in this screening study, which will be used to determine if you are eligible. After participating in this study, you may be assigned to a study that is using an investigational drug. The investigational drug(s) to be used in each of the 4 studies are not approved by the Food and Drug Administration (FDA) for commercial use in this setting; however, the FDA has permitted its use in these research studies.

If you agree to participate in this screening study, your complete medical history (including smoking history) will be recorded and you will have a physical exam, including measurement of vital signs (blood pressure, pulse, temperature, and breathing rate), height, and weight. You will have blood (about 2 teaspoons) drawn for routine tests. You will also have blood (about 1-2 tablespoons) drawn to check your blood clotting function, thyroid function, and lipid (fat) levels. You will have a urine test, a performance status evaluation (questions about your ability to perform everyday activities), and an electrocardiogram (ECG -- a test that measures the electrical activity of the heart).

Your tumor will be evaluated by chest x-ray and computed tomography (CT) or magnetic resonance imaging (MRI) scans to evaluate the status of the disease. You will have a brain MRI. Women who are able to have children must have a negative blood (about 1 teaspoon) pregnancy test before receiving the study drug.

A sample of your tumor tissue will be collected for biomarker analysis. If your tumor tissue cannot be reached, you will not be able to participate in this research study. To collect a tumor biopsy, you will have either a CT-guided core biopsy, bronchoscopy, or other type of biopsy (such as subcutaneous, cutaneous, or lymph node). You will be asked to stop taking any medication that affects blood-clotting (such as aspirin or coumadin) before the biopsy procedure.

For the cutaneous (skin) biopsy, you will be given a local anesthetic by either a spray or shot to numb your skin. A small cut will be made to remove all or a piece of the affected skin.

For the CT-guided core biopsy of the lung, subcutaneous, and/or lymph node biopsy, a tissue sample is withdrawn from an organ or suspected tumor mass using a very thin needle and a syringe. The needle is guided while being viewed by the physician on a CT scan. Any site that can be safely biopsied will be considered for the collection of tissue. Sites not commonly biopsied include kidneys, adrenal glands, and brain.

For the bronchoscopy, you will be given drugs to relax, and then a local anesthetic will be sprayed into your nose and throat to numb those areas. A slim, flexible tube with a light will be placed through your nose or mouth and into your lungs. A small brush will be fed through the tube and into your lungs. The brush will gently scrape off a sample of lung tissue. Tweezers will then be fed through the tube to collect the tissue samples (biopsy). A small amount of water will be sprayed into your lungs and then suctioned out through the tube to collect tissue samples and mucous samples.

For the CT-guided core biopsy or bronchoscopy, you should not take any medications by mouth or have any solid food for at least 6 hours before the procedure. You also should not have any liquids 2 hours before the procedure.

If you are eligible to take part in this study, you will be assigned to 1 of the 4 research studies based on the results of your tumor analysis. You will be asked to read and sign a separate informed consent to take part in one of the research studies.

You have the right to leave the study at any time. If you choose to stop participating in this study, you should contact the study chair and/or research nurse. Your doctor may decide to take you off this study if your medical condition gets worse and/or you are unable to comply with study requirements.

This is an investigational study. Up to 250 patients will take part in this study. All will be enrolled at M. D. Anderson.

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 title	NCT ID	Conditions	Interventions	Eligibility	Organization
BATTLE Program: ZD6474 in Previously Treated Subjects With NSCLC	NCT00410189	Lung Cancer	ZD6474	18 Years -	M.D. Anderson Cancer Center
BATTLE Program: Erlotinib in Previously Treated Subjects With Advanced NSCLC	NCT00410059	Lung Cancer	Erlotinib	18 Years -	M.D. Anderson Cancer Center
BATTLE Program: Sorafenib in Patients With NSCLC	NCT00411671	Lung Cancer	Sorafenib	18 Years -	M.D. Anderson Cancer Center
BATTLE Program: Tarceva and Targretin in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)	NCT00411632	Lung Cancer	Bexarotene Erlotinib	18 Years -	M.D. Anderson Cancer Center
BATTLE Program: Erlotinib in Previously Treated Subjects With Advanced NSCLC	NCT00410059	Lung Cancer	Erlotinib	18 Years -	M.D. Anderson Cancer Center
BATTLE Program: ZD6474 in Previously Treated Subjects With NSCLC	NCT00410189	Lung Cancer	ZD6474	18 Years -	M.D. Anderson Cancer Center
BATTLE Program: Umbrella Protocol for Patients With Non-Small Cell Lung Cancer (NSCLC)	NCT00409968	Lung Cancer	Tumor Biopsy	18 Years -	M.D. Anderson Cancer Center
BATTLE Program: ZD6474 in Previously Treated Subjects With NSCLC	NCT00410189	Lung Cancer	ZD6474	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for battle program