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BATTLE-FL: Front-Line Biomarker-Integrated Treatment Study in Non Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01263782
Recruitment Status : Completed
First Posted : December 21, 2010
Results First Posted : May 8, 2019
Last Update Posted : May 15, 2019
Sponsor:
Collaborators:
Eli Lilly and Company
Genentech, Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

The goal of this clinical research study is to learn if knowing biomarker status can help researchers find better treatment combinations for patients with advanced NSCLC.

Researchers want to use biomarker status to decide what drug (bevacizumab, or cixutumumab) to give in combination with carboplatin and pemetrexed. The safety of these drug combinations will also be studied.


Condition or disease Intervention/treatment Phase
Lung Cancer Drug: Carboplatin Drug: Pemetrexed Drug: Bevacizumab Drug: Cixutumumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: BATTLE-FL: A Biomarker-Integrated Study in Patients With Advanced Non-Small Cell Lung Cancer Treated in the Front-Line (FL) Setting
Actual Study Start Date : May 17, 2011
Actual Primary Completion Date : August 15, 2017
Actual Study Completion Date : August 15, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Carboplatin + Pemetrexed

The chemotherapy will be Carboplatin (AUC 6) and Pemetrexed (500 mg/m2) every 3 weeks for 4 cycles.

Then maintenance Pemetrexed (500 mg/m2 every 3 weeks) will be administered until disease progression or excessive toxicity.

If patients are randomized into one of the arms with a biologic therapy, patients will take the chemotherapy prescribed above, but will also receive the biologic therapy during the same time period.

Drug: Carboplatin
AUC 6 by vein on day 1 of every 21 day cycle for 4 cycles.
Other Name: Paraplatin

Drug: Pemetrexed
500 mg/m2 by vein on day 1 of each 21 day cycle.
Other Names:
  • LY231514
  • Alimta
  • MTA
  • Multitargeted Antifolate
  • NSC-698037

Experimental: Chemo (Carbo/Peme) + Bevacizumab
Carboplatin AUC 6 by vein on day 1 of every 21 day cycle for 4 cycles. Pemetrexed 500 mg/m2 by vein on day 1 of each 21 day cycle. Bevacizumab 15 mg/kg by vein on day 1 of each 21 day cycle.
Drug: Carboplatin
AUC 6 by vein on day 1 of every 21 day cycle for 4 cycles.
Other Name: Paraplatin

Drug: Pemetrexed
500 mg/m2 by vein on day 1 of each 21 day cycle.
Other Names:
  • LY231514
  • Alimta
  • MTA
  • Multitargeted Antifolate
  • NSC-698037

Drug: Bevacizumab
15 mg/kg by vein on day 1 of each 21 day cycle.
Other Names:
  • Avastin
  • Anti-VEGF monoclonal antibody
  • rhuMAb-VEGF

Experimental: Chemo (Carbo/Peme)
Carboplatin AUC 6 by vein on day 1 of every 21 day cycle for 4 cycles. Pemetrexed 500 mg/m2 by vein on day 1 of each 21 day cycle.
Drug: Carboplatin
AUC 6 by vein on day 1 of every 21 day cycle for 4 cycles.
Other Name: Paraplatin

Drug: Pemetrexed
500 mg/m2 by vein on day 1 of each 21 day cycle.
Other Names:
  • LY231514
  • Alimta
  • MTA
  • Multitargeted Antifolate
  • NSC-698037

Experimental: Chemo (Carbo/Peme) + Cixutumumab

Carboplatin AUC 6 by vein on day 1 of every 21 day cycle for 4 cycles. Pemetrexed 500 mg/m2 by vein on day 1 of each 21 day cycle.

Cixutumumab 20 mg/kg by vein on day 1 of each 21 day cycle.

Drug: Carboplatin
AUC 6 by vein on day 1 of every 21 day cycle for 4 cycles.
Other Name: Paraplatin

Drug: Pemetrexed
500 mg/m2 by vein on day 1 of each 21 day cycle.
Other Names:
  • LY231514
  • Alimta
  • MTA
  • Multitargeted Antifolate
  • NSC-698037

Drug: Cixutumumab
20 mg/kg by vein on day 1 of each 21 day cycle.
Other Name: IMC-A12




Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: From treatment start to the time of progression or death, whichever occurred first, or to the time of last contact, assessed up to 5 years ]
    It is defined as from treatment start to the time of progression or death, whichever occurred first, or to the time of last contact. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.


Secondary Outcome Measures :
  1. Overall Response Rate [ Time Frame: From treatment start to every two cycles of completed therapy. ]
    Tumor response was assessed every two cycles of completed therapy. Responses will be based on a comparison to the pretreatment tumor evaluation. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The patient has a diagnosis of pathologically confirmed nonsquamous (nonpredominant squamous) NSCLC by tumor biopsy and/or fine-needle aspiration. Mixed tumors will be categorized by the predominant cell type; if small cell elements are present, the patient is ineligible.
  2. The patient has a diagnosis of either stage IIIB or stage IV NSCLC or has recurrent NSCLC and is not a candidate for curative treatment. Patients may not have had chemotherapy for the advanced setting.
  3. The patient has measurable NSCLC.
  4. The patient's Eastern Cooperative Oncology Group (ECOG) performance status is </=2 at study entry.
  5. The patient should have tumor available for epidermal growth factor receptor (EGFR) mutations, ALK fusions and other molecular analyses. If there is no tissue then the patient has should have biopsy accessible tumor.
  6. The patient has adequate hematologic function as defined by an absolute neutrophil count (ANC) >/= 1,500/mm^3, platelet count >/= 100,000/mm^3, white blood cell count (WBC) >/= 3,000/ mm^3, and hemoglobin >/= 9 g/dL.
  7. The patient has adequate hepatic function as defined by a total bilirubin level </= 1.5 X the upper limit of normal (Serum bilirubin >/= 1.5x Upper Limit of Normal in the setting of known Gilbert's disease is allowed), and alkaline phosphatase, AST and ALT </= 2.5 X the upper limit of normal or </= 5.0 x ULN if liver metastases are present.
  8. The patient has adequate renal function as defined as CrCl of at least 45ml/min.
  9. If patient has brain metastasis, they must have been stable (treated and/or asymptomatic) and off steroids for at least 2 weeks.
  10. The patient is >/= 18 years of age.
  11. The patient has signed informed consent.
  12. Pregnancy Test. Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation and for six (6) months after discontinuation of the study drugs. Childbearing potential will be defined as women who have had menses within the past 12 months, who have not had tubal ligation, hysterectomy 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 for the duration of study participation and for six (6) months after discontinuation of the study drugs.
  13. The ability to interrupt the use of NSAIDS two days before (5 days for long-acting NSAIDs), the day of, and 2 days following administration of Pemetrexed.

Exclusion Criteria:

  1. The patient has received prior definitive therapy (chemotherapy, surgery, or radiotherapy) within 3 months of initiating study drug or within, 2 weeks of localized palliative radiotherapy. Patients treated with initial biologic therapy that progress are eligible (no drug within 4 weeks). Patients must have recovered from the acute toxic effects prior to Day 1 of Cycle 1 to grade </= 1 or baseline.
  2. Patients may not have had prior chemotherapy for first line treatment for NSCLC Stage IIIB/IV. Patient with activating EGFR mutations could have been treated with an EGFR tyrosine kinase inhibitor. Similarly patient with ALK or ROS1 fusions could have had treatment with crizotinib or other ALK inhibitors. Patients may not have had prior biologic therapy with antibodies targeting VEGF,or insulin-like growth factor receptor (IGFR).
  3. The patient has undergone prior thoracic or abdominal surgery within 30 days of study entry, excluding prior diagnostic biopsy.
  4. The patient has a history of uncontrolled angina, arrhythmias, or congestive heart failure.
  5. The patient has inadequately controlled hypertension (defined as systolic blood pressure > 140 and/or diastolic > 90 mm Hg on antihypertensive medications).
  6. The patient has a history of stroke or transient ischemic attack within 6 months prior to Day 1 of Cycle 1.
  7. The patient is unable or unwilling to take folic acid, vitamin B12 supplementation, or dexamethasone according to protocol.
  8. The patient has neuropathy >/= grade 2.
  9. The patient has a history of gastrointestinal fistula, perforation, or abscess, inflammatory bowel disease, or diverticulitis.
  10. The patient is currently receiving ongoing treatment with full-dose warfarin or equivalent (that is, unfractionated and/or low molecular weight heparin).
  11. The patient is pregnant.
  12. The patient is breastfeeding.
  13. Presence of significant third space fluid which cannot be controlled by drainage.
  14. The patient's tumor harbors the EML4-ALK fusion gene.
  15. Drug Specific Eligibility for Treatment Arms. Patients are excluded from the Bevacizumab arm if they have a history of hemoptysis (>/= ½ teaspoon of bright red blood per episode) within 3 months prior to randomization.
  16. Drug Specific Eligibility for Treatment Arms. Patients are excluded from Bevacizumab arm if the Urine Protein Creatinine (UPC) ratio is not within the institutional normal limits.
  17. Drug Specific Eligibility for Treatment Arms. Patients are excluded from the IMC-A12 containing arm if they have poorly controlled diabetes: HBA1C>8% or if the patient has abnormally elevated fasting serum glucose (defined >110% ULN).
  18. Drug Specific Eligibility for Treatment Arms. Patients are excluded if they have known hypersensitivity to any of the drugs.

Information from the National Library of Medicine

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): NCT01263782


Locations
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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Eli Lilly and Company
Genentech, Inc.
Investigators
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Principal Investigator: George Simon, MD M.D. Anderson Cancer Center
  Study Documents (Full-Text)

Documents provided by M.D. Anderson Cancer Center:
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01263782    
Other Study ID Numbers: 2010-0097
NCI-2011-00301 ( Registry Identifier: NCI CTRP )
First Posted: December 21, 2010    Key Record Dates
Results First Posted: May 8, 2019
Last Update Posted: May 15, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by M.D. Anderson Cancer Center:
Non-Small Cell Lung Cancer
NSCLL
Nonsquamous cell
Metastatic disease
Cixutumumab
IMC-A12
Carboplatin
Paraplatin
Pemetrexed
LY231514
Alimta
MTA
Multitargeted Antifolate
NSC-698037
Bevacizumab
Avastin
Anti-VEGF monoclonal antibody
rhuMAb-VEGF
Additional relevant MeSH terms:
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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
Bevacizumab
Carboplatin
Pemetrexed
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors