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BATTLE-2 Program: A Biomarker-Integrated Targeted Therapy Study in Previously Treated Patients With Advanced Non-Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT01248247
Recruitment Status : Active, not recruiting
First Posted : November 25, 2010
Last Update Posted : August 22, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:

Different people have different biomarkers (chemical "markers" in the blood that may be related to your reaction to study drugs). If researchers know about your biomarkers before you receive treatment, they may be able to prescribe a treatment that is better suited to your body's specific needs.

The goal of this clinical research study is to learn if drug or drug combinations based on your biomarkers can help to control NSCLC. The safety of these drug combinations will also be studied.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: Erlotinib Drug: AZD6244 Drug: MK-2206 Drug: Sorafenib Phase 2

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 334 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: BATTLE-2 Program: A Biomarker-Integrated Targeted Therapy Study in Previously Treated Patients With Advanced Non-Small Cell Lung Cancer
Actual Study Start Date : June 2011
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Group 1 - Erlotinib
Erlotinib 150 mg by mouth each day of a 28 day cycle.
Drug: Erlotinib
150 mg by mouth each day of a 28 day cycle.
Other Names:
  • OSI-774
  • Tarceva
Experimental: Group 2 - Erlotinib + MK-2206

Erlotinib 150 mg by mouth each day of a 28 day cycle.

MK-2206 135 mg by mouth every week of a 28 day cycle.

Drug: Erlotinib
150 mg by mouth daily of a 28 day cycle.
Other Names:
  • OSI-774
  • Tarceva
Drug: MK-2206
135 mg by mouth every week of a 28 day cycle.
Experimental: Group 3 - AZD6244 + MK-2206
AZD6244 100 mg by mouth daily of a 28 day cycle. MK-2206 100 mg by mouth every week of a 28 day cycle.
Drug: AZD6244
100 mg by mouth daily of a 28 day cycle.
Drug: MK-2206
100 mg by mouth every week of a 28 day cycle.
Experimental: Group 4 - Sorafenib
Sorafenib 400 mg by mouth twice a day for a 28 day cycle.
Drug: Sorafenib
400 mg by mouth twice a day for a 28 day cycle.
Other Names:
  • Nexavar
  • BAY43-9006

Outcome Measures

Primary Outcome Measures :
  1. 8-Week Disease Control Rate [ Time Frame: 8 weeks ]
    Initial tumor response (unidimensionally measured disease) assessed at completion of two cycles of therapy, and compared to pre-treatment values. Subsequent tumor response for subjects receiving therapy assessed following completion of every two cycles of therapy. Responses based on a comparison to the pre-treatment tumor evaluation. All subjects who have received treatment with at least one cycle of treatment considered evaluable for response.

Eligibility Criteria

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

Inclusion Criteria:

  1. The subject has a diagnosis of pathologically confirmed NSCLC by tumor biopsy and/or fine-needle aspiration.
  2. The subject has a diagnosis of either advanced, incurable stage IIIB or stage IV NSCLC, and failed at least one front-line metastatic NSCLC chemotherapy regimen, or EGFR TKI. (Subjects who have failed adjuvant or locally advanced therapy within 6 months are also eligible to participate in the study).
  3. The subject has measurable NSCLC (patients with active new disease growth in previously irradiated site are eligible).
  4. The subject's ECOG performance status is </= 2 at study entry.
  5. The subject has biopsy accessible tumor
  6. The subject has adequate hematologic function as defined by an absolute neutrophil count (ANC) >/= 1,500/mm3, platelet count >/= 100,000/mm3, WBC >/= 3,000/ mm3, and hemoglobin >/= 9 g/dL.
  7. The subject has adequate hepatic function as defined by a total bilirubin level </= 1.5 x the upper limit of normal (ULN) (bilirubin >/= 1.5 x ULN with 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. Serum creatinine clearance >50ml/min, either by Cockcroft-Gault formula or 24-hour urine collection analysis
  9. If subject has brain metastasis, they must have been stable (treated and/or asymptomatic) and off steroids for at least 2 weeks.
  10. The subject is >/=18 years of age.
  11. The subject has signed informed consent.
  12. The subject is eligible if disease free from a previously treated malignancy, other than a previous NSCLC, for greater than two years. Subject with a history of prior basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix are allowed.
  13. 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, 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.
  14. The subject, if a man, agrees to use effective contraception or abstinence while on study and for 90 days after last dose of study drug.
  15. Subject is able to swallow capsules and has no surgical or anatomical condition that will preclude the patient from swallowing and absorbing oral medications on an ongoing basis.

Exclusion Criteria:

  1. The subject has received prior chemotherapy, surgery, or radiotherapy within 3 weeks of initiating study drug, or 4 weeks for bevacizumab or investigational drug or 72 hours for erlotinib or the subject has not recovered (</= Grade 1) from side effects of the prior therapy (localized palliative radiotherapy within 2 weeks is allowed).
  2. The subject has undergone prior thoracic or abdominal surgery within 30 days of study entry, excluding prior diagnostic biopsy.
  3. The subject has cardiac conditions as follows: uncontrolled hypertension BP > 140/90 despite optimal therapy, uncontrolled angina, ventricular arrhythmias, or congestive heart failure New York Heart Association Class II or above, baseline LVEF </= 50%, prior or current cardiomyopathy, atrial fibrillation with heart rate >100 bpm, unstable ischaemic heart disease (MI within 6 months prior to starting treatment, or angina requiring use of nitrates more than once weekly).
  4. The subject has neuropathy >/= grade 2
  5. The subject is pregnant (confirmed by serum b-HCG if applicable) or is breastfeeding. In the event of inconclusive pregnancy test results, the investigator will have final determination of pregnancy status.
  6. Subjects will be excluded for other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study (i.e., uncontrolled diabetes, severe infection requiring active treatment, severe malnutrition, chronic severe liver or renal disease).
  7. Refractory nausea and vomiting, chronic gastrointestinal diseases (e.g. inflammatory bowel disease), or significant bowel resection that would preclude adequate absorption
  8. Subjects with poorly controlled diabetes (HbA1c >8%) are excluded.
  9. Subjects whose tumor harbors the EML4-ALK fusion gene are excluded unless the patient has failed treatment with Anaplastic Lymphoma Kinase (ALK) inhibitor.
  10. Subjects are excluded if they have QTc prolongation >450 msec (Bazett's Formula) for males or >470 ms for females on screening or other factors that increase the risk of QT prolongation or arrhythmic events (e.g., heart failure, hypokalemia, family history of long QT interval syndrome) including heart failure that meets New York Heart Association (NYHA) class II or above or require use of a concomitant medication that can prolong the QT interval.
  11. Subjects who have abnormal K+ or Mg++ levels will be excluded if these levels cannot be corrected to within normal range with adequate supportive treatment prior to study drug initiation.
  12. Subjects whose tumor harbors an EGFR mutation are excluded unless the subject failed treatment with EGFR TKIs in which case the subject can be randomized to Arms 2, 3, and 4.
  13. Drug Specific Eligibility Criteria based on Treatment Arms- Subjects are excluded from the erlotinib monotherapy arm if they have progressed on prior EGFR TKI therapy; from the AKT inhibitor arm(s) if they have received prior AKT inhibitor therapy; from the MEK inhibitor arm if they have received prior MEK inhibitor therapy; and from Sorafenib arm if they have previously received the drug or have prior history of clinically significant hemoptysis or bleeding diathesis as per principal investigator judgment.
Contacts and Locations

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): NCT01248247

United States, Connecticut
Yale Universtiy
New Haven, Connecticut, United States, 06520
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Merck Sharp & Dohme Corp.
National Cancer Institute (NCI)
Principal Investigator: Vali Papadimitrakopoulou, MD M.D. Anderson Cancer Center
More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01248247     History of Changes
Other Study ID Numbers: 2009-0360
P01 CA148133 ( Other Grant/Funding Number: NCI )
NCI-2011-01104 ( Registry Identifier: NCI CTRP )
First Posted: November 25, 2010    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017

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
Biopsy accessible tumor
Stage IIIB non small cell lung cancer
Stage IV non small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action