Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE2
Total Enrollment
172 participants
Study Classification
INTERVENTIONAL
Study Start Date
2011-04-30
Study Completion Date
2016-06-30
Brief Summary
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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).
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Detailed Description
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Conditions
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Non-Small-Cell Lung Carcinoma
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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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.
Group Type
EXPERIMENTAL
Pemetrexed
Intervention Type
DRUG
Administered intravenously (IV)
Cisplatin
Intervention Type
DRUG
Administered IV
Cixutumumab
Intervention Type
DRUG
Administered IV
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.
Group Type
ACTIVE_COMPARATOR
Pemetrexed
Intervention Type
DRUG
Administered intravenously (IV)
Cisplatin
Intervention Type
DRUG
Administered IV
Interventions
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Pemetrexed
Administered intravenously (IV)
Intervention Type
DRUG
Cisplatin
Administered IV
Intervention Type
DRUG
Cixutumumab
Administered IV
Intervention Type
DRUG
Other Intervention Names
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Alimta
LY231514
LY3012217
Eligibility Criteria
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Inclusion Criteria
* The participant has histologically or cytologically confirmed, nonsquamous (adenocarcinoma/large cell or other) NSCLC.
* The participant has Stage IV disease at the time of study entry.
* Participants 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 participant 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 participant has measurable or nonmeasurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 guidelines.
* The participant 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 participant has adequate bone marrow reserve, and renal and hepatic function
* The participant 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 participant 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 participant has archived tumor tissue available for analysis (can be either primary tumor or metastases).
* The participant has an estimated life expectancy of at least 12 weeks.
* The participant has Stage IV disease at the time of study entry.
* Participants 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 participant 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 participant has measurable or nonmeasurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 guidelines.
* The participant 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 participant has adequate bone marrow reserve, and renal and hepatic function
* The participant 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 participant 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 participant has archived tumor tissue available for analysis (can be either primary tumor or metastases).
* The participant has an estimated life expectancy of at least 12 weeks.
Exclusion Criteria
* 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.
* Participants who have squamous histology.
* The participant's tumor fully or partially contains Small Cell Lung Cancer (SCLC).
* The participant has leptomeningeal disease.
* The participant is currently or has previously received chemotherapy for advanced (Stage IV) NSCLC.
* The participant has a history of treatment with other agents targeting the Insulin-like or Epidermal Growth factor receptors.
* Participants who have received prior Pemetrexed treatment.
* The patient has a known allergy/history of hypersensitivity reaction to any of the treatment components.
* The participant has diabetes mellitus as defined by being treated with glucose lowering medications in the past 3 months prior to enrollment.
* The participant 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 participant has an ongoing or active infection requiring parenteral antibiotic, antifungal, or antiviral therapy.
* The participant has undergone major surgery within 28 days prior to randomization.
* The participant has received a prior autologous or allogeneic organ or tissue transplantation.
* The participant is pregnant or lactating.
* The participant 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 participant has superior vena cava syndrome contraindicating hydration.
* The participant has current clinically-relevant coronary artery disease (New York Heart Association III or IV) or uncontrolled congestive heart failure.
* The participant has any Grade 2 (or greater) peripheral neuropathy.
* The participant 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 participant 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 participant is unwilling or unable to take premedications (folic acid, vitamin B12, or corticosteroids) required by the pemetrexed label.
* The participant has received a recent (within 30 days of enrollment) or is receiving concurrent yellow fever vaccination.
* Participants who have squamous histology.
* The participant's tumor fully or partially contains Small Cell Lung Cancer (SCLC).
* The participant has leptomeningeal disease.
* The participant is currently or has previously received chemotherapy for advanced (Stage IV) NSCLC.
* The participant has a history of treatment with other agents targeting the Insulin-like or Epidermal Growth factor receptors.
* Participants who have received prior Pemetrexed treatment.
* The patient has a known allergy/history of hypersensitivity reaction to any of the treatment components.
* The participant has diabetes mellitus as defined by being treated with glucose lowering medications in the past 3 months prior to enrollment.
* The participant 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 participant has an ongoing or active infection requiring parenteral antibiotic, antifungal, or antiviral therapy.
* The participant has undergone major surgery within 28 days prior to randomization.
* The participant has received a prior autologous or allogeneic organ or tissue transplantation.
* The participant is pregnant or lactating.
* The participant 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 participant has superior vena cava syndrome contraindicating hydration.
* The participant has current clinically-relevant coronary artery disease (New York Heart Association III or IV) or uncontrolled congestive heart failure.
* The participant has any Grade 2 (or greater) peripheral neuropathy.
* The participant 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 participant 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 participant is unwilling or unable to take premedications (folic acid, vitamin B12, or corticosteroids) required by the pemetrexed label.
* The participant has received a recent (within 30 days of enrollment) or is receiving concurrent yellow fever vaccination.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Chicago, Illinois, United States
Site Status
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Hackensack, New Jersey, United States
Site Status
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Portland, Oregon, United States
Site Status
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Memphis, Tennessee, United States
Site Status
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Spokane, Washington, United States
Site Status
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Buenos Aires, , Argentina
Site Status
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La Rioja, , Argentina
Site Status
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Mendoza, , Argentina
Site Status
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Santa Fe, , Argentina
Site Status
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Viedma, , Argentina
Site Status
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Brussels, , Belgium
Site Status
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Duffel, , Belgium
Site Status
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Liège, , Belgium
Site Status
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Barretos, , Brazil
Site Status
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Ijuí, , Brazil
Site Status
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Porto Alegre, , Brazil
Site Status
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Rio de Janeiro, , Brazil
Site Status
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Salvador, , Brazil
Site Status
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São José do Rio Preto, , Brazil
Site Status
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São Paulo, , Brazil
Site Status
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Oshawa, Ontario, Canada
Site Status
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Caen, , France
Site Status
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Clermont-Ferrand, , France
Site Status
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Braunschweig, , Germany
Site Status
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Erfurt, , Germany
Site Status
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Großhansdorf, , Germany
Site Status
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Halle, , Germany
Site Status
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Hanover, , Germany
Site Status
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Ulm, , Germany
Site Status
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Beer Yaakov, , Israel
Site Status
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Tel Aviv, , Israel
Site Status
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Tel Litwinsky, , Israel
Site Status
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Milan, , Italy
Site Status
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Orbassano, , Italy
Site Status
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Perugia, , Italy
Site Status
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Saronno, , Italy
Site Status
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's-Hertogenbosch, , Netherlands
Site Status
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Harderwijk, , Netherlands
Site Status
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Barcelona, , Spain
Site Status
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Girona, , Spain
Site Status
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Madrid, , Spain
Site Status
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Palma de Mallorca, , Spain
Site Status
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Edirne, , Turkey (Türkiye)
Site Status
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Zeytinburnu, , Turkey (Türkiye)
Site Status
Countries
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United States
Argentina
Belgium
Brazil
Canada
France
Germany
Israel
Italy
Netherlands
Spain
Turkey (Türkiye)
Other Identifiers
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I5A-MC-JAEM
Identifier Type: OTHER
Identifier Source: secondary_id
13973
Identifier Type: -
Identifier Source: org_study_id
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NCT01788566
COMPLETED
PHASE2
Study of Pazopanib and Paclitaxel in Advanced Non-small Cell Lung Cancer
NCT00866528
COMPLETED
PHASE1
A Study of Atezolizumab in Combination With Carboplatin or Cisplatin + Pemetrexed Compared With Carboplatin or Cisplatin + Pemetrexed in Participants Who Are Chemotherapy-Naive and Have Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC) (IMpower 132)
NCT02657434
COMPLETED
PHASE3
Study to Evaluate Adverse Events, Optimal Dose, and Change in Disease Activity, With Livmoniplimab in Combination With Budigalimab Plus Chemotherapy Versus IV Infused Pembrolizumab Plus Chemotherapy in Adult Participants With Untreated Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
NCT06236438
ACTIVE_NOT_RECRUITING
PHASE2/PHASE3