A Study in Non-Small Cell Lung Cancer
This study has been completed.
Information provided by (Responsible Party):
Eli Lilly and Company
First received: October 28, 2010
Last updated: July 18, 2016
Last verified: July 2016
The primary purpose of this study is to evaluate the hypothesis that cixutumumab given in combination with cisplatin and pemetrexed is superior to cisplatin and pemetrexed as first-line therapy for patients with advanced nonsquamous non-small cell lung carcinoma (NSCLC).
Non-Small-Cell Lung Carcinoma
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||An Open-label, Multicenter, Randomized Phase 2 Study Evaluating the Safety and Efficacy of Cisplatin and Pemetrexed With or Without Cixutumumab as First-Line Therapy in Patients With Advanced Nonsquamous Non-Small Cell Lung Carcinoma
Primary Outcome Measures:
- Progression-free survival (PFS) [ Time Frame: Baseline to disease progression or death from any cause ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Proportion of patients achieving an objective response (objective response rate) [ Time Frame: Baseline to disease progression ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: Baseline to death from any cause ] [ Designated as safety issue: No ]
- Duration of response [ Time Frame: Time from response to disease progression or death from any cause ] [ Designated as safety issue: No ]
- Time to progressive disease [ Time Frame: Baseline to disease progression ] [ Designated as safety issue: No ]
- Time to worsening of symptoms as measured by Lung Cancer Symptom Scale (LCSS) score [ Time Frame: Baseline to first date of worsening in any one of the six LCSS symptoms ] [ Designated as safety issue: No ]
- Change in tumor size [ Time Frame: Change from baseline measurement to the end of Cycle 2 ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||January 2013 (Final data collection date for primary outcome measure)
Experimental: Pemetrexed + Cisplatin + Cixutumumab
Induction Treatment: Pemetrexed 500 mg/m^2 plus cisplatin 75 mg/m^2 plus cixutumumab 20 mg/kg given intravenously (IV) on Day 1 of a 21 day cycle for up to 4 cycles. Two additional cycles of cisplatin may be given (6 cycles total) for patients with significant tumor size reduction, after sponsor approval.
Maintenance Therapy: Pemetrexed 500 mg/m^2 plus cixutumumab 20 mg/kg given IV every 21 days until progression of disease, unacceptable toxicity, or another withdrawal criterion is met.
Administered intravenously (IV)
Other Name: LY3012217
Active Comparator: Pemetrexed + Cisplatin
Induction Treatment: Pemetrexed 500 mg/m^2 plus cisplatin 75 mg/m^2 given intravenously (IV) on Day 1 of a 21 day cycle for up to 4 cycles. Two additional cycles of cisplatin may be given (6 cycles total) for patients with significant tumor size reduction, after sponsor approval.
Maintenance Therapy: Pemetrexed 500 mg/m^2 given IV every 21 days until progression of disease, unacceptable toxicity, or another withdrawal criterion is met.
Administered intravenously (IV)
|Ages Eligible for Study:
||18 Years and older (Adult, Senior)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- The patient has histologically or cytologically confirmed, nonsquamous (adenocarcinoma/large cell or other) NSCLC.
- The patient has Stage IV disease at the time of study entry.
- Patients with treated brain metastases are eligible if they are clinically stable with regard to neurologic function, off steroids after cranial irradiation (whole brain radiation therapy, focal radiation therapy, and stereotactic radiosurgery) ending at least 14 days prior to randomization, or after surgical resection performed at least 28 days prior to randomization. The patient may have no evidence of Grade 1 (or greater) Central Nervous System (CNS) hemorrhage based on pretreatment scans(performed within 21 days before randomization).
- The patient has measurable or nonmeasurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 guidelines.
- The patient has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.
- If prior adjuvant or neoadjuvant chemotherapy, the last dose of adjuvant or neoadjuvant treatment was administered at least 6 months prior to randomization.
- The patient has adequate bone marrow reserve, and renal and hepatic function
- The patient has fasting serum glucose less than or equal to 125 mg/dL, and hemoglobin A1C less than or equal to 6%.
- Females with reproductive potential: Must have a negative serum or urine pregnancy test within 7 days prior to the first dose of any study drug.
- Males and females with reproductive potential: Must agree to use medically approved contraceptive precautions during the study and for 6 months following the last dose of any study drug.
- The patient has the ability to understand and the willingness to sign a written informed consent form.
- Previous radiation therapy is allowed to less than 25% of the bone marrow, but should have been limited and must not have included whole pelvis radiation.
- The patient has archived tumor tissue available for analysis (can be either primary tumor or metastases).
- The patient has an estimated life expectancy of at least 12 weeks.
- Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device or off-label use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
- Patients who have squamous histology.
- The patient's tumor fully or partially contains Small Cell Lung Cancer (SCLC).
- The patient has leptomeningeal disease.
- The patient is currently or has previously received chemotherapy for advanced (Stage IV) NSCLC.
- The patient has a history of treatment with other agents targeting the Insulin-like or Epidermal Growth factor receptors.
- Patients who have received prior Pemetrexed treatment.
- The patient has a known allergy/history of hypersensitivity reaction to any of the treatment components.
- The patient has diabetes mellitus as defined by being treated with glucose lowering medications in the past 3 months prior to enrollment.
- The patient has an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring parenteral antibiotics, symptomatic congestive heart failure, uncontrolled hypertension, clinically significant cardiac arrhythmia,or psychiatric/social situations that would limit compliance with study requirements.
- The patient has an ongoing or active infection requiring parenteral antibiotic, antifungal, or antiviral therapy.
- The patient has undergone major surgery within 28 days prior to randomization.
- The patient has received a prior autologous or allogeneic organ or tissue transplantation.
- The patient is pregnant or lactating.
- The patient has a history of another primary cancer, with the exception of the following: curatively resected nonmelanomatous skin cancer, curatively treated carcinoma in situ, or other primary solid tumor treated with curative intent and no known active disease present and no treatment administered during the last 5 years.
- The patient has superior vena cava syndrome contraindicating hydration.
- The patient has current clinically-relevant coronary artery disease (New York Heart Association III or IV) or uncontrolled congestive heart failure.
- The patient has any Grade 2 (or greater) peripheral neuropathy.
- The patient has clinically significant third-space fluid collections, for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to study entry.
- The patient is unable to interrupt aspirin or other nonsteroidal anti-inflammatory agents, other than an aspirin dose less than or equal to 1.3 grams per day, for a 5-day period (8-day period for long-acting agents, such as piroxicam).
- The patient is unwilling or unable to take premedications (folic acid, vitamin B12, or corticosteroids) required by the pemetrexed label.
- The patient has received a recent (within 30 days of enrollment) or is receiving concurrent yellow fever vaccination.
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01232452
Eli Lilly and Company
||Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
||Eli Lilly and Company
||Eli Lilly and Company
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 28, 2010
||July 18, 2016
||United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Spain: Ministry of Health
Belgium: Ministry of Social Affairs, Public Health and the Environment
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Italy: The Italian Medicines Agency
Turkey: Ministry of Health
Israel: Ministry of Health
Brazil: Ministry of Health
Argentina: Ministry of Health
Keywords provided by Eli Lilly and Company:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 21, 2016
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Respiratory Tract Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors