BATTLE Program: Umbrella Protocol for Patients With Non-Small Cell Lung Cancer (NSCLC)
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ClinicalTrials.gov Identifier: NCT00409968 |
Recruitment Status :
Completed
First Posted : December 12, 2006
Last Update Posted : January 13, 2020
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Condition or disease | Intervention/treatment |
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Lung Cancer | Procedure: Tumor Biopsy |

Study Type : | Observational |
Actual Enrollment : | 341 participants |
Observational Model: | Case-Only |
Time Perspective: | Prospective |
Official Title: | A Biomarker-Integrated Study in Chemorefractory Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) |
Actual Study Start Date : | November 27, 2006 |
Actual Primary Completion Date : | October 31, 2019 |
Actual Study Completion Date : | October 31, 2019 |

Group/Cohort | Intervention/treatment |
---|---|
Screening Study
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.
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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). |
- Biomarker Profile Assessment (before randomized allocation to research study) [ Time Frame: At enrollment ]
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- The patient has a diagnosis of pathologically confirmed NSCLC by tumor biopsy and/or fine-needle aspiration
- The patient has a diagnosis of either stage IIIB, stage IV, or advanced, incurable NSCLC, and failed at least one front-line metastatic NSCLC chemotherapy regimen. (Patients who have failed adjuvant or locally advanced therapy within 6 months are also eligible to participate in study).
- The patient has uni-dimensionally measurable NSCLC.
- Karnofsky performance status >/= 60 or ECOG performance status 0-2
- The patient has biopsy accessible tumor.
- The patient has adequate hematologic function as defined by an absolute neutrophil count (ANC) >/= 1,500/mm^3, platelet count >/= 100,000/mm^3, WBC >/= 3,000/ mm^3, and hemoglobin >/= 9 g/dL.
- The patient has adequate hepatic function as defined by a total bilirubin level </= 1.5 X the upper limit of normal, and alkaline phosphatase, AST or ALT </= 2.5 X the upper limit of normal.
- The patient has adequate renal function as defined by a serum creatinine level </= 1.5 mg/dL or a calculated creatinine clearance of >/= 60cc/minute.
- The patient has PT < 1.5 x upper limit of normal
- If patient has brain metastasis, they must have been stable (treated or asymptomatic) for at least 4 weeks after radiation if treated with radiation and not have used steroids for at least 1 week. Re-imaging performed after 2 weeks, upon completion of radiation therapy.
- The patient is >/= 18 years of age.
- The patient has signed informed consent.
- The patient is eligible if disease free from a previously treated malignancy, other than a previous NSCLC, for greater than two years. Patients with a history of prior basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix are exempt from exclusion.
- Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Childbearing potential will be defined as women who have had menses within the past 12 months,who have not had tubal ligation or bilateral oophorectomy.Should a woman become pregnant or suspect that she is pregnant while participating in this study,she should inform her treating physician immediately.The patient,if a man,agrees to use effective contraception or abstinence.
- Subject must be considered legally capable of providing his or her own consent for participation in this study.
Exclusion Criteria:
- The patient has received prior investigational therapy, chemotherapy, surgery, or radiotherapy within 4 weeks of initiating study drug
- The patient has undergone prior thoracic or abdominal surgery within 28 days of study entry, excluding prior diagnostic biopsy.
- The patient has received radiation therapy to the measurable tumor within 6 months. Patients are allowed to have local irradiation for the management of tumor-related symptoms (bones, brain). However, if a patient has active new disease growing in the previously irradiated site, the patient will be eligible to participate in the study.
- The patient has a significant medical history or unstable medical condition (unstable systemic disease: congestive heart failure (New York Heart Association Functional Classification class II or worse), recent myocardial infarction within 3 months, unstable angina, active infection (i.e. currently treated with antibiotics), uncontrolled hypertension). Patients with controlled diabetes will be allowed. Patient must be able to undergo procedure for tissue acquisition.
- The patient has uncontrolled seizure disorder, active neurologic disease, or neuropathy >/= grade 2. Patients with meningeal or CNS involvement by tumor are eligible for the study if the above exclusion criteria are not met.
- The patient is pregnant (confirmed by serum Beta-HCG if applicable) or is breastfeeding.
- Any condition that is unstable or could jeopardize the safety of the patient and its compliance in the study, in the investigator's judgment.
- The patient is actively taking herbal remedies or over-the-counter biologics (e.g., shark cartilage, high dose antioxidants).
- Patients will be allowed to have prior biologic (i.e. VEGF, EGFR, etc.) therapy. However, the patient will be excluded from a given study if he/she has received the same therapy as the clinical trial (i.e. If a patient has been previously treated with bevacizumab, they are allowed to enroll in any of the 4 studies. If a patient has been previously treated with erlotinib, they are excluded from the clinical trials with erlotinib). In addition, if a patient has been previously treated with gefitinib (Iressa), they are excluded from the clinical trials with erlotinib.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00409968
United States, Texas | |
University of Texas MD Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Vali Papadimitrakopoulou, MD | M.D. Anderson Cancer Center |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00409968 |
Other Study ID Numbers: |
2005-0823 W81XWH-06-1-0303 ( Other Identifier: U.S. Department of Defense ) NCI-2018-01767 ( Registry Identifier: CTRP ID ) |
First Posted: | December 12, 2006 Key Record Dates |
Last Update Posted: | January 13, 2020 |
Last Verified: | January 2020 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Lung Cancer Non Small Cell Lung Cancer BATTLE Program |
Umbrella Trial Tumor Biopsy NSCLC |
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms |